Sexual Health

Instructions for Use

PS-001402





Device Name

Visby Medical Sexual Health Test

Common or Usual Name

Visby Sexual Health Test

CLIA Waived

A Certificate of Waiver is required to perform this test in a CLIA Waived setting. To

obtain CLIA waiver information and a Certificate of Waiver, please contact your state

health department. Additional CLIA waiver information is available at the Centers for

Medicare and Medicaid website at www.cms.hhs.gov/CLIA.

Failure to follow the instructions or any modifications to the test will result in the test

no longer meeting the requirements for waived classification.

Intended Use

The Visby Medical Sexual Health Test is a single-use (disposable), fully integrated,

automated Polymerase Chain Reaction (PCR) in vitro diagnostic test intended for use

in point-of-care or clinical laboratory settings for the rapid detection and

differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and

Trichomonas vaginalis in self-collected female vaginal swab specimens using the

Visby Medical Sexual Health Vaginal Specimen Collection Kit in a health care setting.

The test results are to aid in the diagnosis of symptomatic or asymptomatic infections

with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Summary and Explanation of the Procedure

Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis

(TV) are three of the most common Sexually Transmitted Infections (STIs) in the

United States. These infections are called “silent infections” as many infected people

are asymptomatic and lack abnormal physical examination findings. In 2018, the

Centers for Disease Control and Prevention (CDC) estimated that 4 million chlamydial

infections, 1.6 million gonococcal infections, and over 2 million trichomoniasis

infections occur annually in the United States but more than half are not reported

because most people are asymptomatic and are therefore not tested.

1,2,3

CT are gram-negative, nonmotile obligate intracellular bacteria. This species currently

includes nineteen serovars that can induce disease in humans, with Serovars D

through K known to be the major cause of genital chlamydial infections in men and

women.

If CT infections are left untreated, they can cause non-gonococcal urethritis,

acute salpingitis (an infection of the fallopian tubes), proctitis, cervicitis, and

epididymitis. Furthermore, in women, untreated CT can cause pelvic inflammatory

disease (PID) in about 10-15% of the infected population, which can subsequently

cause permanent damage to fallopian tubes, uterus, or surrounding tissues which

can result in chronic pelvic pain, infertility, and ectopic pregnancy.

NG, the causative agent of gonorrheal disease, are gram-negative, non-motile

diplococci. Although most Gonococcal infections are uncomplicated lower and upper

genital tract infections, some can also be asymptomatic. Testing is essential in these

cases as untreated NG infections in women can lead to PID, which can then cause the

onset of salpingitis, pelvic peritonitis, tuboovarian abscesses, and endometritis.

Untreated NG infections may also develop Disseminated Gonococcal Infection (DGI),

Visby Medical Sexual Health Test

Instructions for Use

a potentially life threating condition which is usually characterized by arthritis,

tenosynovitis and/or dermatitis.

TV is a protozoan parasite that causes trichomoniasis, the most common curable STI,

with approximately 2 million new cases occurring annually in the US. However, only

approximately 30% of TV infections are symptomatic.

Women who are symptomatic

may experience vaginal discharge, vulvovaginal soreness, dysuria and/or irritation.

Patients with trichomoniasis have an increased risk of getting and spreading other

sexually transmitted infections, including HIV. In addition, pregnant women with

trichomoniasis are at higher risk of premature labor and having low-birth-weight

babies.

Principles of the Procedure

The Visby Medical Sexual Health Test is a single-use (disposable), fully integrated,

rapid, compact device containing a PCR-based assay for direct qualitative detection

and differentiation of DNA from CT, NG, and TV. The test system includes the Visby

Medical Sexual Health device, the Visby Medical power supply, the Visby Medical

Vaginal Specimen Collection kit, and fixed-volume transfer pipettes. The device

processes a vaginal swab sample by automatically performing all steps required to

complete lysis, polymerase chain reaction, and amplicon detection.

The patient uses the Visby Medical Vaginal Specimen Collection Kit to self-collect a

vaginal specimen with the provided flocked swab, and then the patient elutes the

specimen into the Visby Medical Collection Media. The test operator transfers the

collection media containing the patient specimen into the sample port of the device

using the provided fixed-volume pipette, where it rehydrates a lyophilized internal

process control. The sample enters a lysis module, where the DNA of the sample and

the internal process control are extracted using a combination of chemical lysis and

high temperature. The extracted DNA enters a mixing chamber where it rehydrates

lyophilized PCR reagents, followed by thermocycling to amplify target DNA. If present,

the amplified pathogen target (CT, NG, and/or TV) and internal process control

hybridize to specific probes located on a flow channel. Detection of the target-specific

PCR product is accomplished via an enzyme-linked colorimetric assay using

streptavidin bound horseradish peroxidase (HRP) and a colorimetric substrate that

forms a purple precipitate. Test results can be expected in approximately 30 minutes:

a green check mark will appear, and a purple color will appear in the “Results Valid”

spot, indicating a valid test. A purple spot adjacent to “Chlamydia,” “Gonorrhea,” and/

or “Trichomoniasis” signifies the presence of amplified CT, NG, and/or TV DNA in the

sample.

Materials Required

Materials Provided in 10 Pack Test Kit

Visby Medical Sexual Health Test – Quantity 10

Visby Fixed Volume Pipette (650 µl) – Quantity 12

Materials Required and Available as Accessories

Visby Power Adapter

(PS-000885 or PS-000288)

Visby Medical Sexual Health Vaginal

Specimen Collection Kit‡

Materials Required but Not Provided

Gloves

External Controls

NATtrol™ Chlamydia trachomatis (CT), Neisseria

gonorrhoeae (NG), Trichomonas vaginalis (TV)

by ZeptoMetrix Corporation

+ Control SKU:

NATCTNGTV-POS-IVD

- Control SKU:

NATCTNGTV-NEG-IVD

The Visby Medical Sexual Health device can only be used with the Visby

Medical Sexual Health Vaginal Specimen Collection Kit.

Visby Medical Sexual Health Test

Instructions for Use

Warnings and Precautions

General

1. For in vitro diagnostic use. Rx only.

2. For use only with female vaginal swabs collected in the Visby Medical Sexual

Health Vaginal Specimen Collection Kit.

3. Do not re-sterilize unused swabs from the Visby Medical Sexual Health Vaginal

Specimen Collection Kit.

4. This product is for single use only; do not reuse the Visby Medical Sexual Health

device.

5. Federal law restricts the sale of this device unless it is by or on the order of a

licensed practitioner (US only).

6. Colorblind users may be unable to differentiate red, green, and white status lights.

However, they can consult the light location and shape of the light to determine

test status. When interpreting results, the purple shade may appear as a dark

shade for some users.

7. Results from The Visby Medical Sexual Health device must be interpreted in

accordance with these Instructions for Use.

8. The specimen collection media is a clear colorless, and odorless solution. Do not

use if the solution appears discolored or has a strong odor.

Safety and Contamination Prevention

1. Follow your institution’s safety procedures for working with chemicals and

handling biological samples.

2. Wear gloves while handling samples. If the gloves come in contact with specimen

or appear to be wet, change gloves to avoid contaminating other specimens.

Change gloves between processing of each specimen and before leaving the

work area and upon entry into work areas.

3. Keep the work area clean to prevent contamination.

4. Do not try to disassemble the Visby Medical Sexual Health device.

5. Treat all biological specimens, including a used Visby Medical Sexual Health

device, as if capable of transmitting infectious agents. All biological specimens

should be treated with standard precautions. Guidelines for specimen handling

are available from the U.S. Centers for Disease Control and Prevention and the

Clinical Laboratory Standards Institute.

5,6

6. If a spill with the Visby Medical Sexual Health Test occurs, soak up spill with an

absorbent material. Spray the contaminated area and materials with 10% bleach.

Wipe down the surface so that it is saturated with bleach and let rest for at least

10 minutes. Once a minimum of 10 minutes has passed, wipe the area down with

an absorbent material, such as paper towels, followed by rinsing the area with

water. Discard the Visby Medical Sexual Health device according to your

Institution’s standard practices.

7. If a spill occurs on the Visby power adapter, unplug the unit and wipe it down

vigorously with 70% ethyl or isopropyl alcohol. Allow the power adapter to

completely dry before using it again.

8. Safety Data Sheets (SDS) are available at Visby Medical Customer Support 1-833-

GoVisby (1-833-468-4729).

Electromagnetic Compatibility (EMC) Safety

1. Use of this equipment adjacent to or stacked with other equipment should be

avoided because it could result in improper operation. If such use is necessary,

this equipment and the other equipment should be observed to verify that they

are operating normally.

2. Portable RF communications equipment (including peripherals such as antenna

cables and external antennas) should be used no closer than 30 cm (12 inches)

to any part of the Visby Medical Sexual Health Test, including cables specified by

the manufacturer. Otherwise, degradation of the performance of this equipment

could result.

Visby Medical Sexual Health Test and Accessories

1. Do not use the Visby Medical Sexual Health device if it has been dropped or

appears to be broken or is past its expiration date.

2. Do not shake or tilt the Visby Medical Sexual Health device after adding a sample.

3. Store the Visby Medical Sexual Health device sealed in the foil pouch prior to use.

4. Do not move or unplug the Visby Medical Sexual Health device while it is running.

5. The Visby power adapter should be replaced if an increased number of RED X

errors are observed. Failure to do so may result in invalid results.

6. Only use the supplied Visby power adapter (9 V, 3.5 A DC) to power the Visby

Medical Sexual Health device. Using other power adapters to operate the Visby

Medical Sexual Health device will void the safety protection of the device and

could result in increased electromagnetic emissions or decreased

electromagnetic immunity of this equipment and result in improper operation.

7. The Visby Medical Sexual Health device is best used in a room with adequate

lighting and away from glare. Failure to do so may result in an inability to see the

results on the test.

8. The Visby Medical Sexual Health device should be disposed of in the appropriate

specimen waste containers according to the Institution’s standard practices.

9. The results of the Visby Medical Sexual Health device must be read within 120

minutes (2 hours) after the green check mark light appears.

10. The purple switch on the Visby Sexual Health device must be fully closed to start

the test. Failure to completely close the switch will result in failure to start the test

and can cause invalid test results.

11. The Visby Sexual Health device should be placed and operated on a flat surface

with the front of the device facing up. Placing the device at 90° angle on its side

can result in invalid or false negative test results.

Note: Dispose of the power adapter per your local, federal, and institutional guidelines.

Specimen

1. Only patient-collected vaginal swab specimens taken with the Visby Medical

Sexual Health Vaginal Specimen Collection Kit should be used with The Visby

Medical Sexual Health Test.

2. Failure to add sufficient sample volume to the test can lead to invalid results.

3. The Visby Medical Sexual Health device requires a specific volume of specimen.

Use the provided fixed-volume pipette to transfer sample to the device.

4. The Visby Medical Sexual Health Test should not be used if antiperspirants and

deodorants or the following vaginal products (douches, washes, lubricants,

vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area)

were used by the patient within 48 hours of collection.

5. Do not dilute patient samples.

6. Samples can contain inhibitors that may generate invalid results.

Color Blindness Precaution

Visby Medical Sexual Health Test

Instructions for Use

While colorblind users may be unable to differentiate red, green, and white

status lights, they can consult the light location and shape of the light to

determine test status.

Test Kit and Device Storage

Store the Visby Medical Sexual Health Test kit and device between 36°F and 86°F (2°C

and 30°C), and between 5% and 80% humidity. Do not freeze. In case of refrigeration or

other exposure to cold temperatures, ensure that the Visby Medical Sexual Health

device is allowed to fully come to at least its minimum operating temperature of 55°F

(13°C) prior to use.

Specimen Collection and Storage

Female vaginal swab specimens tested with the Visby Medical Sexual Health Test

must be collected by the patient in clinical settings in accordance with the Visby

Medical Sexual Health Vaginal Specimen Collection Kit Instructions for Use and

following the Self-Collection Instructions. The performance of this test has not been

evaluated with other specimen types or other specimen collection devices.

Note: Ensure that patients read and understand the Self-Collection Instructions before

providing them with the Visby Medical Sexual Health Vaginal Specimen Collection Kit.

The Visby Medical Sexual Health Vaginal Specimen Collection Kit may

contain irritants. Do not ingest the contents of the tube. If the contents of

the tube are splashed in your eyes, flush your eyes with water. If the

contents splash onto your skin, wash with soap and water. If irritation

persists, notify a health care provider.

For best results, patient-collected samples should be tested as soon as possible. If the

sample cannot be immediately tested, they can be stored as shown in the following

table.

Patient Sample Storage Specifications

Room Temperature

Up to 4 hours between

64°F - 86°F (18°C - 30°C)

Refrigerated

Up to 4 hours between

36°F - 46°F (2°C – 8°C)

Frozen

Up to 90 days at less

than 5°F (<-15°C)

For refrigerated specimens, ensure the cap is securely tightened. Invert specimen

tube at least 5 times to re-suspend any settled specimen particulates or mucus

before loading into the Visby Medical Sexual Health device.

For frozen specimens, allow the tube to reach room temperature for 1-2 hours prior to

use. Once at room temperature, ensure the cap is securely tightened. Invert specimen

tube at least 5 times to re-suspend any settled specimen particulates or mucus

before transferring the specimen into the Visby Medical Sexual Health device.

Visby Medical Sexual Health Test Procedure

Follow these instructions carefully. This test is designed for use by health care

professionals.

Operating Conditions

TEMPERATURE

55°F - 91°F

(13°C - 33°C)

HUMIDITY

5% - 80%

PRESSURE

-300ft  9500ft

(102.5 kPa – 71 kPa)

Run the test on a clean,

level surface. Test

samples within four

hours of collection.

Setup | Prepare the Workspace Place device on a level surface

A. Clean your workspace and

gather all the required materials,

then unwrap the device.

Note: Use the device immediately

after unwrapping. Use new gloves

for each test.

B. Plug the Visby Power Adaptor

into the device power port.

C. Remove the sticker over the

sample port.

Visby Medical Sexual Health Test

Instructions for Use

Step 1 | Mix and Add Patient Sample

A. Mix the patient sample

(or control) by gently

inverting the tube 5

times.

B. Squeeze the upper

bulb of the provided

pipette and submerge

the tip to the bottom of

the sample tube.

C. Release the upper

bulb slowly to fill the

shaft. Keep pipette tip

submerged until shaft is

full. Extra fluid should

enter the lower bulb.

D. Check that there are

no air bubbles in the

shaft. Note: Do not

squeeze lower bulb or

invert the pipette.

E. Place the tip at the

bottom of the sample

port and then squeeze

the upper bulb of the

pipette to release all of

the sample.

F. Discard the pipette

according to your

institution’s guidelines

immediately. Do not set it

down.

Step 2 | Run the Test Do not move test while running

A. Immediately after

sample addition, slide the

switch upwards in a firm,

swift motion to fully close

the sample port to ensure

the test is started.

B. Check that the first

progress indicator light is

blinking. Lights will initially

blink and then become

stable as the test

progresses.

C. Wait approximately 28

minutes for a green check

mark to appear indicating

the test is finished running.

Note: If a red X appears at

any point, stop, do not

read test results, and

retest.

Step 3

Interpret Results

If the test is invalid, stop, and retest!

A. Determine if the test is valid.

Green check and purple spot

next to “Results Valid” = Valid

Test

Red X

no purple spot next

to “Results Valid” =

Invalid

Test

B. Read the test results. Note: Results may be read up to 2 hours after the test is completed.

Do not read results if test is invalid.

Examples of possible results:

Negative: No spot next to the target is a

negative result.

Positive: Any shade of purple with distinct

edges next to the target is a positive result.

Intensity of the spot may vary. Any shade of color with distinct edges

should be considered positive.

Read Results

Stop and Retest

Visby Medical Sexual Health Test

Instructions for Use

Interpretation of Results: Use the following table to determine next steps and

reporting of patient test results.

Indicator Light

Results Valid

Spot

Chlamydia

Spot

Gonorrhea

Spot

Trichomoniasis

Spot

Next Steps

Test Results

Red X

N/A

Retest

Invalid

Green ✓

Absent

N/A

Retest

Invalid

Green ✓

Present

Absent

Report

Results

Chlamydia trachomatis

Detected

Neisseria gonorrhoeae

Not Detected

Trichomonas vaginalis

Not Detected

Green ✓

Present

Absent

Present

Absent

Report

Results

Chlamydia trachomatis

Not Detected

Neisseria gonorrhoeae

Detected

Trichomonas vaginalis

Not Detected

Green ✓

Present

Absent

Present

Report

Results

Chlamydia trachomatis

Not Detected

Neisseria gonorrhoeae

Not Detected

Trichomonas vaginalis

Detected

Green ✓

Present

Absent

Report

Results

Chlamydia trachomatis

Detected

Neisseria gonorrhoeae

Detected

Trichomonas vaginalis

Not Detected

Green ✓

Present

Absent

Present

Report

Results

Chlamydia trachomatis

Detected

Neisseria gonorrhoeae

Not Detected

Trichomonas vaginalis

Detected

Green ✓

Present

Absent

Present

Report

Results

Chlamydia trachomatis

Not Detected

Neisseria gonorrhoeae

Detected

Trichomonas vaginalis

Detected

Green ✓

Present

Report

Results

Chlamydia trachomatis

Detected

Neisseria gonorrhoeae

Detected

Trichomonas vaginalis

Detected

Green ✓

Present

Absent

Report

Results

Chlamydia trachomatis

Not Detected

Neisseria gonorrhoeae

Not Detected

Trichomonas vaginalis

Not Detected

Retest Procedure

If a retest is required, obtain the leftover sample from the Visby collection media tube.

If the leftover sample has been stored for ≤ 4 hours, then repeat the test with a new

Visby Medical Sexual Health device. If the leftover sample has exceeded the storage

recommendations (four hours at room temperature or under refrigeration), and/or if

the sample volume is insufficient, collect a new sample and repeat the test with a new

Visby Medical Sexual Health Test. If a retest continues to return an invalid result,

collect a new sample and repeat the test with a new Visby Medical Sexual Health Test.

If the positive or negative external controls fail, repeat the test with a new Visby

Medical Sexual Health device.

If a repeat test fails, please contact Visby Medical Customer Support at 1-833-468-

4729 (1-833-GoVisby).

Quality Control

The Visby Medical Sexual Health Test has built-in procedural controls. These include

an internal process control and built-in electronic control. The result of the process

control is displayed in the detection window while the results of the electronic controls

are displayed using the status lights.

Internal Process Control

The Visby Medical Sexual Health device contains an internal process control. The

internal process control monitors effective sample preparation, PCR amplification,

and detection. If these steps are completed successfully, then a purple spot will

develop next “Results Valid” in the detection window. If the purple spot does not

appear, the test result is Invalid, and the test must be repeated with a new Visby

Sexual Health device.

Built-in Electronic Control

The electronic controls monitor the device to ensure proper operation. If the electronic

control passes, a green check mark status light appears. If this control fails, a “Red X”

status light appears. A “Red X” error will occur if (1) the device is being operated

outside of its temperature range, (2) the power is interrupted during a run, (3) a

device error is detected, or (4) the test is not started within 2 hours of the device being

plugged in. In the event of a “Red X”, the test is invalid, and the test must be repeated

with a new Visby Sexual Health device.

Visby Medical Sexual Health Test

Instructions for Use

External Positive and Negative Controls

Good laboratory practice suggests the use of positive and negative controls to ensure

that the test is working properly and that the test is correctly performed.

Test these controls using the same process that is used for testing a patient sample.

The external control should be run once with each new shipment of test kits and once

for each untrained operator. Further controls may be tested to conform with local,

state and/or federal regulations, accrediting groups, or your laboratory’s standard

Quality Control procedures.

NATtrol™ Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas

vaginalis (TV) Controls by ZeptoMetrix™ Corporation

Product Code

Unit

Control Key

NATtrol

CT/NG/TV

Positive Control

SKU: NATCTNGTV-

POS-IVD

Six (6)

1 mL Vials

per Kit

Valid Positive

Control Run

NATtrol

CT/NG/TV

Negative Control

SKU: NATCTNGTV-

NEG-IVD

Six (6)

1 mL Vials

per Kit

Valid Negative

Control Run

Limitations

1. The performance characteristics of the Visby Medical Sexual Health Test have not

been evaluated in women less than 14 years of age.

2. This test has only been validated with female vaginal specimens self-collected in

clinical settings, using the Visby Medical Sexual Health Vaginal Specimen

Collection Kit. The performance of this test has not been evaluated with other

specimen types or other specimen collection devices.

3. Not for use with self-collected specimens in home setting.

4. Erroneous results may occur from improper specimen collection, technical error,

sample mix-up, or if the organism in the patient sample is below the limit of

detection of the Visby Medical Sexual Health Test.

5. Careful compliance with the instructions in this insert, the Quick Reference Guide

Instructions, and Visby Medical Sexual Health Vaginal Specimen Collection Kit

instruction documents are necessary to avoid erroneous results.

6. Because the detection of CT, NG, and TV are dependent on the DNA present in the

sample, reliable results are dependent on proper sample collection, handling, and

storage.

7. As with other assays of this type, there is a risk of false negative or invalid results

due to the presence of sequence variants (mutations) in the amplification

targets.

8. A negative result does not preclude a possible infection. If clinical symptoms

persist, additional testing should be performed.

9. The Visby Medical Health Test should not be used by patients using

antiperspirants and deodorants or the following vaginal products: douches,

washes, lubricants, vaginal swabs, vaginal moisturizers, or feminine hygiene spray

in the genital area, within 48 hours of sample collection.

10. This test has been evaluated with human specimen material only.

11. The effect of interfering substances has been evaluated only for those listed in the

interfering substances section of this document.

12. Assay interference was observed in the presence of the following substances:

RepHresh Odor Eliminating pH Balancing Gel at a concentration greater than 1.25%

w/v; Replens Long Lasting Vaginal Moisturizer at a concentration greater than

2.5% w/v; Dove 0% alcohol antiperspirant spray at concentration greater than

0.19% w/v; Menstrual blood at a concentration greater than 2.5% v/v.

13. Results from the Visby Sexual Health Test should be interpreted in conjunction with

other clinical and laboratory data available to the clinician.

14. In cases where it is suspected the reporting of a positive result will have adverse

socioeconomic impact, a new sample should be collected, and tested with an

alternate assay.

15. The Visby Sexual Health Test is not intended for the evaluation of suspected

sexual abuse or for other medico-legal indications.

Equivalence between the Visby Medical Sexual Health Test and the Visby

Medical Sexual Health Click Test

The Visby Medical Sexual Health Test (Ref #: PS-001402, referenced as Visby Test

hereafter) is an updated version of original test, the Visby Medical Sexual Health Click

Test (Ref #: PS-000175, referenced as Click Test hereafter). Both tests use the same

reagents and are composed of the same materials. The housing and fluidic path of

the Visby Test was modified to improve test usability and reliability; however, the test

was developed to be functionally equivalent to the original test. Clinical performance

presented in the following section, was established based on the data from the Click

Test. For the purpose of demonstrating that the performance of the Visby Test is

equivalent to the original version of the test, clinical comparison studies were

performed. The data is shown in the “Clinical Comparison Study between Visby Test

and Click Test” section of this document.

Visby Medical Sexual Health Test

Instructions for Use

Expected Values

The prevalence of infection with CT, NG, and/or TV in patient populations depends on

risk factors such as age, gender, the presence or absence of symptoms, the type of

clinic, and the sensitivity of the test used to detect infections. During the clinical

evaluation of the Click Test, the positivity rate for detection of CT, NG, and/or TV using

the Click Test, by clinical study site and overall, is shown in the table below. These

values also apply to the Visby Test.

Table 1. Positivity Rate of the Visby Test for Detection of CT, NG, and/or TV during the Clinical

Study

Site

% Percent Positive (# positive / # tested)

CT only

positive

NG only

positive

TV only

positive

CT & NG

positive

CT & TV

positive

NG & TV

positive

CT, NG, & TV

positive

2.7%

(5/185)

0.5%

(1/185)

1.1%

(2/185)

0.0%

(0/185)

0.0%

(0/185)

0.0%

(0/185)

0.0%

(0/185)

2.1%

(5/236)

1.3%

(3/236)

18.6%

(44/236)

0.0%

(0/236)

2.5%

(6/236)

0.0%

(0/236)

0.0%

(0/236)

1.5%

(1/67)

1.5%

(1/67)

9.0%

(6/67)

0.0%

(0/67)

0.0%

(0/67)

0.0%

(0/67)

0.0%

(0/67)

21.2%

(57/269)

4.1%

(11/269)

8.2%

(22/269)

3.3%

(9/269)

3.7%

(10/269)

1.1%

(3/269)

2.2%

(6/269)

1.6%

(1/61)

1.6%

(1/61)

14.8%

(9/61)

0.0%

(0/61)

1.6%

(1/61)

1.6%

(1/61)

3.3%

(2/61)

8.6%

(23/269)

0.7%

(2/269)

0.4%

(1/269)

0.4%

(1/269)

0.4%

(1/269)

0.0%

(0/269)

0.0%

(0/269)

3.0%

(10/332)

0.6%

(2/332)

12.3%

(41/332)

0.3%

(1/332)

1.2%

(4/332)

0.0%

(0/332)

0.3%

(1/332)

0.0%

(0/15)

6.7%

(1/15)

13.3%

(2/15)

0.0%

(0/15)

0.0%

(0/15)

0.0%

(0/15)

0.0%

(0/15)

5.1%

(3/59)

0.0%

(0/59)

10.2%

(6/59)

1.7%

(1/59)

1.7%

(1/59)

0.0%

(0/59)

0.0%

(0/59)

3.9%

(2/51)

0.0%

(0/51)

7.8%

(4/51)

0.0%

(0/51)

2.0%

(1/51)

0.0%

(0/51)

2.0%

(1/51)

6.4%

(5/78)

1.3%

(1/78)

5.1%

(4/78)

1.3%

(1/78)

0.0%

(0/78)

0.0%

(0/78)

0.0%

(0/78)

10.5%

(6/57)

0.0%

(0/57)

5.3%

(3/57)

5.3%

(3/57)

0.0%

(0/57)

1.8%

(1/57)

0.0%

(0/57)

12.7%

(8/63)

1.6%

(1/63)

3.2%

(2/63)

1.6%

(1/63)

3.2%

(2/63)

1.6%

(1/63)

3.2%

(2/63)

10.6%

(5/47)

2.1%

(1/47)

6.4%

(3/47)

0.0%

(0/47)

2.1%

(1/47)

0.0%

(0/47)

0.0%

(0/47)

All

7.3%

(131/1789)

1.4%

(25/1789)

8.3%

(149/1789)

1.0%

(17/1789)

1.5%

(27/1789)

0.3%

(6/1789)

0.7%

(12/1789)

Performance Characteristics

Clinical Performance

Performance characteristics of the Click Test were established in two multi-center

studies conducted at 14 clinical sites representative of CLIA waived testing facilities.

The sites were geographically distributed across the United States and included an

OB/GYN physician’s office, sexual health clinics, primary care clinics, a public health

clinic, a university student health clinic, an HIV/AIDS clinic, and STD clinics. A total of 32

untrained operators, representative of CLIA waived users, participated in the study.

The study subjects were prospectively enrolled females, 14 years of age and older,

who self-collected vaginal swab specimens using the Visby Vaginal Specimen

Collection Kit. The average age among study participants was 34 years, with a range

between 14 to 80 years of age.

The table below shows the prevalence of each pathogen at each study site based on

the comparator results.

Table 2. Pathogen Prevalence by Site and Overall (based on comparator results)

Site

% (# positive / # tested)

1.6% (3/185)

0.5% (1/184)

0.0% (0/184)

3.9% (9/233)

1.3% (3/236)

18.9% (42/222)

1.5% (1/66)

1.5% (1/67)

4.6% (3/65)

27.2% (72/265)

9.3% (25/269)

9.8% (26/266)

6.6% (4/61)

4.9% (3/61)

13.3% (8/60)

8.6% (23/268)

0.7% (2/269)

3.7% (12/326)

0.9% (3/330)

11.2% (37/330)

0.0% (0/15)

6.7% (1/15)

13.3% (2/15)

6.8% (4/59)

1.7% (1/59)

6.8% (4/59)

0.0% (0/51)

5.9% (3/51)

6.4% (5/78)

2.6% (2/78)

3.9% (3/77)

10.5% (6/57)

1.8% (1/57)

11.1% (7/63)

1.6% (1/63)

4.8% (3/63)

14.9% (7/47)

2.1% (1/47)

6.4% (3/47)

Total

8.6% (153/1774)

2.5% (45/1786)

7.8% (137/1765)

The collected samples were provided to participating study operators who tested

them on-site using the Click Test. The participating operators conducted the test by

following the instructions in the Quick Reference Guide (QRG). The study operators

had no formal training or experience with CLIA high or moderate complexity testing

and did not receive any training on the use of the Visby test.

Three additional vaginal swabs were collected from each female by a licensed

clinician and were sent to one central laboratory for comparator testing with three

FDA cleared nucleic acid amplification tests (NAATs) detecting CT, NG, and TV.

A total of 1899 subjects were initially enrolled, of which 1881 met the study inclusion

criteria. Of those, 1789 females (929 symptomatic and 860 asymptomatic) were

included in the performance evaluation. Study samples were excluded from the data

analysis due to lack of a valid Visby test result (n=28) or for protocol deviations

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(n=64), (e.g., failure to follow the study protocol, improper execution of the Visby test).

Samples were also excluded from the data analysis due to lack of a valid comparator

test result (CT=15, NG=3 and TV=24). Among the 1817 tests performed on the Visby

Test, 119 had an invalid result on the first test, for an overall invalid rate of 6.55%

(119/1817), with 95% CI (5.5%-7.8%).

The Click Test results for CT and NG were compared to a composite comparator result

(CCR) comprised of results of three FDA-cleared NAATs testing clinician collected

vaginal swabs. A positive (infected) comparator result for CT and NG was determined

when at least two of the three comparator assays were positive. The performance

estimates for the Visby Test for the detection of CT and NG were calculated as positive

percent agreement (PPA) and negative percent agreement (NPA) with the composite

comparator result.

The following two tables summarize the clinical performance of the Click Test for CT

and NG when compared to the CCR.

Table 3. Clinical Performance of the Click Test for CT vs. Composite Comparator Results, by

Symptom Status

Symptom

Status

Prevalence%

PPA

(95% CI)

NPA

(95% CI)

Symptomatic

918

795

10.6%

97.9%

(92.8-99.4%)

96.8%

(95.4-97.8%)

Asymptomatic

856

790

6.5%

96.4%

(87.9-99.0%)

98.8%

(97.7-99.3%)

Overall

1774

149

1585

8.6%

97.4%

(93.5-99.0%)

97.8%

(96.9-98.4%)

PPA=Positive Percent Agreement with CCR; NPA=Negative Percent Agreement with CCR;

TP=true positive; FP=false positive; TN=true negative; FN=false negative

Table 4. Clinical Performance of the Click Test for NG vs. Composite Comparator Results, by

Symptom Status

Symptom

Status

Prevalence %

PPA

(95% CI)

NPA

(95% CI)

Symptomatic

929

896

2.7%

100.0%

(86.7-100.0%)

99.1%

(98.3-99.6%)

Asymptomatic

857

829

2.3%

95.0%

(76.4-99.1%)

99.0%

(98.1-99.5%)

Overall

1786

1725

2.5%

97.8%

(88.4-99.6%)

99.1%

(98.5-99.4%)

PPA=Positive Percent Agreement with CCR; NPA=Negative Percent Agreement with CCR;

TP=true positive; FP=false positive; TN=true negative; FN=false negative

The clinical performance of the Visby Test for detection of T. vaginalis was compared

to a patient infected status (PIS) determined by testing clinician collected vaginal

swabs with three FDA cleared NAATs for TV. The patient was considered infected if at

least two of the three comparator assays were positive for TV. The performance

estimates for the Visby Test for the detection of TV were calculated as percent

sensitivity and percent specificity when compared with the PIS.

The following table summarizes the clinical performance of the Click Test for T.

vaginalis when compared to the PIS.

Table 5. Clinical Performance of the Click Test for TV vs. PIS, by Symptom Status

Symptom

Status

Prevalence%

Sensitivity %

(95% CI)

Specificity %

(95% CI)

Symptomatic

916

797

9.2%

98.8%

(93.6%-99.8%)

95.8%

(94.2%-97.0%)

Asymptomatic

849

778

6.2%

100%

(93.2%-100.0%)

97.7%

(96.5%-98.6%)

Overall

1765

136

1575

7.8%

99.3%

(96.0%-99.9%)

96.7%

(95.8%-97.5%)

TP=true positive; FP=false positive; TN=true negative; FN=false negative

The following table shows the comparator results that determined the infected / not

infected composite comparator result for CT.

Table 6. Patient CT status by CCR

Patient

Infected

Status – CT

NAAT 1

NAAT 2

NAAT 3

Visby

Symptom Status

Symptomatic

Asymptomatic

Infected

Non-infected

317

366

Non-infected

471

415

Total

918

856

Test not done

Invalid test result

Visby Medical Sexual Health Test

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The following table shows the comparator results that determined the infected / not

infected composite comparator result for NG.

Table 7. Patient NG status by CCR

Patient

Infected

Status – NG

NAAT 1

NAAT 2

NAAT 3

Visby

Symptom Status

Symptomatic

Asymptomatic

Infected

Non-infected

372

391

Non-infected

512

430

Total

929

857

Test not done

Invalid test result

The following table shows the patient infected status for TV based on testing vaginal

swabs.

Table 8. Patient Infected Status – TV

Patient

Infected

Status – TV

NAAT 1

NAAT 2

NAAT 3

Visby

Symptom Status

Symptomatic

Asymptomatic

Infected

Non-infected

Non- infected

330

356

Non-infected

448

406

Total

916

849

Test not done

Invalid test result

Comparison study between Visby Test and Click Test

Three studies were conducted to evaluate the equivalence of the Visby Test with the

Click Test.

Multicenter study with Untrained Operators

This study was conducted in CLIA Waived (CW) testing environments at three study

sites. A subset of archived frozen self-collected vaginal swab patient samples that

had been previously characterized in the clinical study for the Click Test were tested.

A total of 30 CT positive (based on comparator results from the clinic study for Click

Test, and this is the same for other analytes and negative sample), 20 NG positive, 30

TV positive, and 33 negative vaginal swab specimens were selected for the study. Six

(6) untrained study operators (two operators at each site) conducted the testing.

The frozen samples were de-identified, randomized, and blinded so that the study

staff and test operators did not know the expected results. Operators thawed the

samples and tested them on-site using the Visby Test by following the instructions in

the Quick Reference Guide (QRG). The results of the Visby Test were compared to the

recorded results of the Click Test. Of the 102 samples included in the study, two (2.4%)

had an initial invalid test result. One sample was excluded from the data analysis

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because it was invalid upon retesting. There were no additional exclusions. Table 9

summarize the concordance between the Click Test results and the Visby Test results.

Table 9. Clinical Performance of the Visby Test compared to the Click test (performed by

untrained operators)

Target

PPA (95% CI)

NPA (95% CI)

101

100.0%

(88.6%-100.0%)

100.0%

(94.9%-100.0%)

101

100.0%

(83.9%-100.0%)

100.0%

(95.5%-100.0%)

101

100.0%

(88.6%-100.0%)

95.8%

(88.3%-98.6%)

PPA=Positive Percent Agreement; NPA=Negative Percent Agreement.

TP=true positive; FP=false positive; TN=true negative; FN=false negative.

Single Center study with trained operators

A second clinical comparison study was performed to include all frozen specimens

with sufficient volume from the original clinical study of the Click Test, with a focus on

testing samples representing a natural distribution of the pathogen loads among

individuals, especially these with low target levels. To obtain a sufficient number of

positive specimens (by comparator assays) for each analyte, these specimens were

further supplemented with archived and banked frozen self-collected samples from

two other previous Visby Medical specimen collections. These specimens were tested

in house by seven trained operators over seven days and under variable lighting

conditions. The specimens were randomized and blinded so that the test operators

did not know the expected results.

A total of 359 de-identified, frozen, self-collected vaginal swab specimens were

included in this study. Operators thawed the samples and tested them with both the

Visby Test and the Click Test if sufficient sample volume was present. Specimens

without sufficient volume to run on both devices were tested only on the Visby Test,

and the original Click Test results were used for the comparison.

Of the 359 specimens included in the study, one specimen did not have sufficient

volume to run on any test and thus was excluded from the study. Of the remaining

358 specimens tested on the Visby Test, 11 (3.1%) had an initial invalid test result. As a

final result, seven specimens were excluded from performance calculation due to

insufficient sample volume for retest or failure to obtain a valid retest result.

Therefore, a total of 351 specimens were included in the performance table. Table 10

summarizes the concordance between the Visby Test results and the Click Test

results.

Table 10. Clinical Performance of the Visby Test compared to the Click Test (testing by

trained operators)

Target

PPA (95% CI)

NPA (95% CI)

351

116

232

100.0%

(96.8%-100.0%)

98.7%

(96.3%-99.6%)

351

317

100.0%

(89.9%-100.0%)

100.0%

(98.8%-100.0%)

351

100

240

93.5%

(87.1%-96.8%)

98.4%

(95.9%-99.4%)

TV PIS (based on the original clinical study for Click Test) for all seven specimens were

negative.

Testing spiked samples at low organism concentrations

To further evaluate the performance of the Visby Test as compared to Click Test at

low levels of the target organisms, samples spiked at 1.5x LoD, 2x LoD or 3x LoD for

each target in individual negative clinical matrix were prepared and tested. Twenty

(20) CT positive, 20 NG positive, 20 TV positive and 20 negative samples were tested

on both the Visby Test and Click Test by four trained operators at a single site. Testing

was performed over two days under various lighting conditions in a randomized and

blinded fashion. All 80 contrived samples yielded valid results (0% initial invalid) and

are included in the final data analysis.

Table 11 summarizes the concordance of the results between the Visby Test and the

Click Test.

Table 11. Performance of the Visby Test compared to the Click Test (spiked samples tested

by trained operators)

Organism

Concentration

Correct Results / Total Tested

Click Test

Visby Test

1.5x LoD

6/6

5/6

2x LoD

10/10

9/10

3x LoD

4/4

1.5x LoD

5/6

2x LoD

9/10

10/10

3x LoD

4/4

1.5x LoD

6/6

2x LoD

10/10

3x LoD

4/4

Negative

N/A

20/20

19/20*

* One device was unexpectedly positive for TV

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Analytical Performance

Most analytical studies described below were performed with the Click Test and are

representative and applicable to the Visby test. Two studies, including the

“Comparison of Limit of Detection between the Visby Test and Click Test” and the

“Reproducibility for the Visby Test” were performed on the Visby Test.

Limit of Detection

Limit of Detection (LoD) of the Click Test was determined for CT in elementary bodies

per mL (EB/mL), NG in colony forming units per mL (CFU/mL), and TV in trophozoites

per mL (troph/mL), from two distinct strains or serovars, seeded into clinical negative

vaginal sample matrix. LoD is defined as the lowest concentration per sample that

can be reproducibly distinguished from negative samples (the lowest concentration

at which 95% samples are determined to be positive).

Each organism was individually seeded into negative vaginal swab sample matrix

and tested in a range-finding study at five different concentrations in replicates of 20

per concentration. A single lot of negative sample matrix and a single lot of Click Tests

were used throughout this study.

The LoD values for each strain were estimated by probit analysis of the results from

the range-finding study. The calculated LoDs were verified by testing 20 replicates at

the estimated LoD concentration and demonstrating that at least 19 out of 20

replicates were positive.

The LoD for each organism is shown in the table below.

Table 12. LoD of CT Serovars, NG strains, and TV strains in Clinical Negative Vaginal Sample Matrix

Organism

LoD

CT Serovar H (VR-879)

16.0 EB/mL

CT Serovar D (VR-885)

5.9 EB/mL

NG (ATCC 19424)

5.7 CFU/mL

NG (ATCC 49226)

6.2 CFU/mL

TV (ATCC 30001) (metronidazole susceptible)

1.2 troph/mL

TV (ATCC 30238) (metronidazole resistant)

0.24 troph/mL

Comparison of Limit of Detection between the Visby Test and Click Test

The purpose of this study is to demonstrate that the LoD for the Visby Test is

equivalent to the Click Test. The LoD values were determined to be equivalent if the

lowest concentrations of organism with at least 19/20 detection rate from the two

devices were within 3-fold of each other. Negative pooled clinical vaginal sample in

Visby Collection Media was spiked at the LoD that was established with the Click Test

and tested with 20 Visby Tests and 20 Click Tests. If at least 19/20 devices returned a

positive test result, the organism was diluted 3-fold and the testing was repeated until

the detection rate was <19/20 for both the Click and Visby test. The results in Table 13

confirm that the LoD between the Click Test and Visby Test are comparable.

Table 13. LoD comparison between the Visby Test and the Click Test

Organism

LoD Multiple

Target

Concentration

Detection Rate (Positive Valid

Devices / Total Valid Devices

Tested)

Click Test

Visby Test

CT Serovar H

(VR-879)

16.00 EB/mL

20/20

1/3x

5.33 EB/mL

13/20

18/20

CT Serovar D

(VR-885)

5.90 EB/mL

20/20

1/3x

1.97 EB/mL

11/20

19/20

1/9x

0.66 EB/mL

7/20

10/20

(ATCC 49226)

6.20 cfu/mL

19/20

20/20

1/3x

2.06 cfu/mL

10/20

19/20

1/9x

0.68 cfu/mL

5/20

9/20

(ATCC 19424)

17.1 cfu/mL

20/20

5.7 cfu/mL

17/20

20/20

1/3x

1.9 cfu/mL

17/20

19/20

1/9x

0.63 cfu/mL

8/20

9/20

(ATCC 30001)

1.2 troph/ mL

19/20

20/20

1/3x

0.4 troph/mL

20/20

19/20

1/9x

0.13 troph/mL

16/20

(ATCC 30238)

0.24 troph/mL

20/20

1/3x

0.08 troph/mL

17/20

a. Metronidazole susceptible

b. Metronidazole resistant

Inclusivity

The ability of the Click Test to detect 14 serovars of CT, 30 strains of NG, and 15 strains

of TV at or near the LoD was evaluated. Each organism was individually seeded into

negative clinical vaginal swab matrix at or near 2x LoD and tested in 3 replicates. If

any strain did not result in 3/3 detection, then the next lower dilution was tested until

detected in 3/3. All 14 CT serovars, 30 NG strains, and 15 TV strains were successfully

detected at the following concentrations:

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Table 14. CT Organisms Tested in Inclusivity Study

ATCC Number

Serovar

CT Concentration Tested

VR-346

32 EB/mL

VR-347

32 EB/mL

VR-348B

32 EB/mL

VR-571B

32 EB/mL

VR-573

32 EB/mL

VR-878

32 EB/mL

VR-880

128 EB/mL

VR-886

32 EB/mL

VR-887

32 EB/mL

VR-901B

LGV I

32 EB/mL

VR-902B

LGV II

64 EB/mL

VR-903

LGV III

32 EB/mL

VR-1500

32 EB/mL

nvCT, Swedish variant

32 EB/mL

Table 15. NG Organisms Tested in Inclusivity Study

ATCC Number

NG Concentration

Tested

ATCC Number

NG Concentration

Tested

BAA-1833

12.4 cfu/mL

27632

12.4 cfu/mL

BAA-1839

12.4 cfu/mL

27633

12.4 cfu/mL

BAA-1847

24.8 cfu/mL

31148

12.4 cfu/mL

9826

12.4 cfu/mL

31149

12.4 cfu/mL

9827

12.4 cfu/mL

31151

12.4 cfu/mL

9830

12.4 cfu/mL

31356

12.4 cfu/mL

10874

12.4 cfu/mL

31397

12.4 cfu/mL

11688

12.4 cfu/mL

31398

12.4 cfu/mL

11689

12.4 cfu/mL

31401

12.4 cfu/mL

19088

12.4 cfu/mL

31402

12.4 cfu/mL

23050

12.4 cfu/mL

31403

12.4 cfu/mL

23051

12.4 cfu/mL

31406

12.4 cfu/mL

27628

12.4 cfu/mL

35541

12.4 cfu/mL

27629

12.4 cfu/mL

43069

12.4 cfu/mL

27631

12.4 cfu/mL

49981

12.4 cfu/mL

Table 16. TV Organisms Tested in Inclusivity Study

ATCC Number

TV Concentration Tested

PRA-95

2.4 troph/mL

PRA-98

2.4 troph/mL

30184

2.4 troph/mL

30187

2.4 troph/mL

30188

2.4 troph/mL

30236

2.4 troph/mL

30240

2.4 troph/mL

30245

2.4 troph/mL

50138

2.4 troph/mL

50139

2.4 troph/mL

50141

2.4 troph/mL

50143

2.4 troph/mL

50147

2.4 troph/mL

50167

2.4 troph/mL

50183

2.4 troph/mL

Cross Reactivity and Microbial Interference

The cross reactivity of the Click Test was evaluated by testing 144 different

microorganisms in replicates of 3 in negative vaginal swab matrix. Quantified stocks

of whole microorganisms were spiked into the matrix and tested at high

concentrations (>10

genomic copies/mL for bacteria and >10

genomic copies/mL for

viruses). No cross reactivity was observed with any of the organisms tested.

Microbial Interference, when testing with the Click Test, was evaluated by testing the

same 144 microorganisms in the presence of low concentrations of the target

organisms (3X LoD for CT, NG and TV). No microbial interference was observed with

any of the organisms tested.

Additionally, three organisms could not be obtained for direct testing (Bacterial

Vaginosis Associated Bacteria 2 (BVAB-2), Megasphaera type 1, and Dientamoeba

fragilis). The sequences of these organisms were analyzed against the Click Test

primer and amplicon sequences using basic local alignment search tool (BLAST). No

match was found for any of the 3 organisms.

Note: The organisms evaluated in the two studies are listed in the table on the

following pages.

Table 17. Microorganisms Evaluated for Cross-Reactivity and Microbial Interference

Microorganism (ATCC Number)

Achromobacter xerosis (14780)

Acinetobacter calcoaceticus (23055)

Acinetobacter lwoffii (15309)

Actinomyces israelii (12102)

Aerococcus viridans (700406)

Aeromonas hydrophila (35654)

Alcaligenes faecalis (8750)

Arcanobacterium pyogenes (49698)

Atopobium vaginae (BAA-55)

Bacteroides fragilis (25285)

Bacteroides ureolyticus (33387)

Bergeriella denitrificans (14686)

Bifidobacterium adolescentis (15703)

Bifidobacterium breve (15700)

Bifidobacterium longum (15697)

Blastocystis hominis (50629)

Brevibacterium linens (21330)

BV associated bacteria (BVAB-2, N/A)*

Campylobacter jejuni (33291)

Candida albicans (801504, Zeptometrix)

Candida glabrata (90030)

Candida parapsilosis (22019)

Candida tropicalis (750)

Chlamydophila pneumoniae (53592)

Chlamydophila psittaci (MBC013-R, Vircell)

Chlamydia trachomatis LGVII (VR-902B)**

Chromobacterium violaceum (12472)

Citrobacter freundii (8090)

Clostridium difficile (9689)

Clostridium perfringens (13124)

Corynebacterium genitalium (33034)

Corynebacterium xerosis (373)

Cryptococcus neoformans (66031)

Cryptosporidium parvum (PRA-67DQ)

Cutibacterium acnes (6919)

Deinococcus radiodurans (13939)

Derxia gummosa (15994)

Dientamoeba fragilis (N/A)*

Microorganism (ATCC Number)

Eikenella corrodens (23834)

Elizabethkingia meningoseptica (13253)

Entamoeba histolytica (30458)

Enterococcus faecalis (29212)

Enterococcus faecium (19434)

Enterobacter cloacae (13047)

Enterococcus raffinosus (avium) (49464)

Erysipelothrix rhusiopathiae (19414)

Escherichia coli (700928D-5)

Fusobacterium nucleatum (25586)

Gardnerella vaginalis (801894)

Gemella haemolysans (10379)

Giardia intestinalis (50581)

Haemophilus ducreyi (33940)

Haemophilus influenzae (49247)

Herpes simplex virus I (VR-539)

Herpes simplex virus II (VR-540)

HIV-1 (synthetic RNA) (VR-3245SD)

Human papilloma virus 16 (synthetic DNA)

(VR-3240SD)

Human papilloma virus 16 E6/E7 (Transformed

cells) (CRL-2616)

Kingella dentrificans (33394)

Kingella kingae (23330)

Klebsiella aerogenes (13048)

Klebsiella oxytoca (49131)

Klebsiella pneumoniae (801506, Zeptometrix)

Lactobacillus acidophilus (4356)

Lactobacillus brevis (14869)

Lactobacillus crispatus (33820)

Lactobacillus jensenii (25258)

Lactobacillus vaginalis (49540)

Lactococcus lactis (19435)

Legionella pneumophila (33152, 33153)

Listeria monocytogenes (19115)

Megashaera type 1 (N/A)*

Micrococcus luteus (4698)

Mobiluncus curtisii (35241)

Microorganism (ATCC Number)

Mobiluncus mulieris (35243)

Moraxella lacunata (17967)

Moraxella osloensis (19976)

Moraxella (Branhamella) catarrhalis (25240)

Morganella morganii (25830)

Mycobacterium smegmatis (14468)

Mycoplasma genitalium (49123)

Mycoplasma hominis (23114)

Neisseria elongata (25295, 29315, 49378)

Neisseria cinerea (14685)

Neisseria subflava (14221)

Neisseria flavescens (13116, 13120)

Neisseria perflava (14799)

Neisseria lactamica (23970, 23971, 23972,

49142)

Neisseria meningitidis serogroup a (13077)

Neisseria meningitidis serogroup b (13090)

Neisseria meningitidis serogroup c (13102,

13105, 13112, 19577)

Neisseria meningitidis serogroup D (13113)

Neisseria meningitidis serogroup w-135

(35559)

Neisseria meningitidis serogroup y (35561)

Neisseria polysaccharea (43768)

Neisseria subflava (49275)

Neisseria mucosa (19695, 25998, 49233)

Neisseria sicca (9913, 29193, 29256)

Pantoea agglomerans (27155)

Paracoccus denitrificans (13543)

Pentatrichomonas hominis (30000)

Peptostreptococcus anaerobius (27337)

Peptostreptococcus productus (Blautia

producta) (35244)

Microorganism (ATCC Number)

Plesiomonas shigelloides (51903)

Prevotella bivia (29303)

Proteus mirabilis (7002)

Proteus vulgaris (6380)

Providencia stuartii (33672)

Pseudomonas aeruginosa (801519,

Zeptometrix)

Pseudomonas fluorescens (13525)

Pseudomonas putida (12633)

Rahnella aquatilis (33071)

Rhodospirillum rubrum (11170)

Saccharomyces cerevisiae (9763)

Salmonella minnesota (49284)

Salmonella typhimurium (19585)

Serratia marcescens (13880)

Staphylococcus aureus (12600)

Staphylococcus epidermidis (14990)

Staphylococcus saprophyticus (15305)

Streptococcus agalactiae (13813)

Streptococcus bovis (35034)

Streptococcus mitis (49456)

Streptococcus mutans (25175)

Streptococcus pneumoniae (6303)

Streptococcus pyogenes (19615)

Streptococcus salivarius (13419)

Streptococcus sanguinis (10556)

Streptomyces griseinus (23915)

Ureaplasma urealyticum (27618)

Trichomonas tenax (30207)

Vibrio parahaemolyticus (17802)

Yersinia enterocolitica (23715)

* These organisms were not available for direct testing and were evaluated using in-silico analysis

** This organism was correctly positive with the CT assay and negative for NG and TV

Visby Medical Sexual Health Test

Instructions for Use

Interfering Substances

The performance of the Click Test in the presence of potentially interfering substances

that may be found in a vaginal swab sample was evaluated. The potential interfering

substances were diluted in the negative swab matrix and tested in the presence of

low concentrations (3x LoD) of CT, NG, and TV organisms. The testing was also

performed with negative clinical swab matrix samples. All samples were tested in

triplicate.

The following substances were tested and found not to interfere with the assay up to

the concentrations shown below.

Table 18. Potentially Interfering Substances

Substances

Concentration

Abreva Cold Sore Cream

0.25% w/v

Beta Estradiol

0.07 mg/mL

Biotin

3.5 µg/mL

Dove 0% alcohol

anti-perspirant spray

0.19% w/v

KY Jelly personal lubricant

0.25% w/v

Leukocytes

1x10

cells/mL

Menstrual Blood

2.50% v/v

Monistat 1

0.25% w/v

Mucin (bovine)

0.80% w/v

Preparation H Hemorrhoidal

Ointments

0.25% w/v

Progesterone

0.07 mg/mL

RepHresh Odor Eliminating pH

Balancing Gel

1.25% w/v

Substances

Concentration

Replens Long Lasting Vaginal

Moisturizer

2.50% w/v

Seminal fluid

5.00% v/v

Summer's Eve Povidone- Iodine

Medicated Douche

0.25% w/v

Summer's Eve, Cleansing Wash

0.40% w/v

Vaginal anti-fungal

0.25% w/v

7-day Vaginal cream

0.25% w/v

Vagisil Moisturizer

0.25% w/v

Vagisil Regular Strength Anti-Itch

Creme

0.25% w/v

VCF Vaginal Contraceptive Gel

0.25% w/v

Yeast Gard Douche Advanced

0.25% w/v

Dove 0% alcohol anti-perspirant spray may cause false positive results for CT, NG, and/or TV when

present at a concentration greater than 0.19% (w/v)

Menstrual blood may cause invalid results when present at a concentration greater than 2.50%

(v/v)

RepHresh Odor Eliminating pH Balancing Gel may cause false negative results for CT and/or NG

when present at a concentration greater than 1.25% (w/v)

Replens Long Lasting Vaginal Moisturizer may cause invalid results when present at a

concentration greater than 2.50% (w/v)

Competitive Interference

The Click Test was evaluated for performance in the case of a mixed infection

(presence of multiple target organisms). Each of the target organisms (CT, NG, and

TV) were seeded into clinical negative vaginal sample matrix at varying

concentrations and then tested in triplicate. Low concentrations were prepared at 3x

LoD for the respective organisms and high concentrations were prepared at 1 x 10

units/mL. No competitive interference was observed at the levels tested for any of the

three target organisms.

Table 19. Competitive Interference for each Target Organisms

Organism and Concentration

CT (# Positive /

# Tested)

NG (# Positive /

# Tested)

TV (# Positive /

# Tested)

Low

3/3

Low

High

3/3

Low

High

Neg

3/3

0/3

Low

Neg

High

3/3

0/3

3/3

High

Low

High

3/3

High

Low

Neg

3/3

0/3

Neg

Low

High

0/3

3/3

High

Low

3/3

Neg

High

Low

0/3

3/3

High

Neg

Low

3/3

0/3

3/3

High

Neg

3/3

0/3

Neg

High

Neg

0/3

3/3

0/3

Neg

High

0/3

3/3

Visby Medical Sexual Health Test

Instructions for Use

Reproducibility

A reproducibility study was performed to evaluate the reproducibility of the Click Test

when used by untrained users in CLIA waived settings. The operators performing the

testing were non-laboratorians representing healthcare professionals that may be

encountered at such sites. The study evaluated four (4) panel members that were

prepared using cultured organisms in negative pooled clinical vaginal swab matrix

(previously determined to be negative for CT, NG, TV). The study was performed with

negative (unspiked) and positive samples.

A total of six (6) study operators (2 operators at each site) tested the panel three (3)

times each testing day, over six (6) non-consecutive days. Three reagent lots were

used in the study. A summary of the results (count correct / total count) and %

agreement with expected results for each analysis is presented in the table below.

The Click Test demonstrated robust reproducibility with no significant effect observed

for the components of variation evaluated (sites, days, operators, lots).

Table 20. Summary of Reproducibility Results with Click Test

Site 1

Site 2

Site 3

Overall Agreement

Panel Member

% Agreement

(count)

% Agreement

(count)

% Agreement

(count)

% Agreement

(count)

95% CI

CT Positive

(49.72 EB/mL)

100%

(35/35)

100%

(36/36)

100%

(36/36)

100%

(107/107)

92.1%-99.0%

NG Positive

(22.68 cfu/mL)

97.1%

(34/35)

94.3%

(33/35)

100%

(36/36)

97.2%

(103/106)

92.0%-99.0%

TV Positive

(21.6 troph/mL)

100%

(36/36)

100%

(35/35)

100%

(35/35)

100%

(106/106)

96.5%-100%

Negative

97.2%

(35/36)

100%

(36/36)

97.2%

(35/36)

98.1%

(106/108)

93.5%-99.5%

One sample had invalid results and was omitted from the analysis.

One sample was positive result for CT, but unexpectedly positive for NG and TV

Two samples were Ct positive, but unexpectedly positive for TV

One sample was unexpectedly positive for TV

One sample was unexpectedly positive for NG

An additional study using low positive (spiked at ~1X LoD) and negative (unspiked)

samples was performed to evaluate the repeatability of test results near the assay

LoD when tested by untrained operators in a CLIA waived setting. A total of six (6)

operators (2 operators at each site) tested the panel twice a day for 5 days, for a total

of 60 data points per panel member. The composition of the panel members along

with summary of results (count correct / total count) and percent agreement with the

expected result for each panel member is presented in the table below. The study

demonstrated that untrained users can perform the test and interpret the results

accurately when testing samples with organism concentrations near the LoD.

Table 21. Summary of Study with Samples Near Assay LoD

Site 1

Site 2

Site 3

Overall Agreement

Panel Member

% Agreement

(count)

% Agreement

(count)

% Agreement

(count)

% Agreement

(count)

95% CI

CT Low Positive

(16.0 EB/mL)

100%

(20/20)

100%

(20/20)

100%

(20/20)

100%

(60/60)

94.0%-100%

NG Low Positive

(6.2 cfu/mL)

95.0%

(19/20)

95.0%

(19/20)

100%

(20/20)

96.7%

(58/60)

88.6%-99.1%

TV Low Positive

(1.2 troph/mL)

100%

(20/20)

95.0%

(19/20)

95.0%

(19/20)

96.7%

(58/60)

88.6%-99.1%

Negative

100%

(18/18)*

100%

(20/20)

100%

(20/20)

100%

(58/58)

93.8%-100%

*Two samples had invalid results and were omitted from the analysis.

Reproducibility for the Visby Test

A reproducibility study was conducted at three (3) study sites with CLIA Waived

settings by untrained operators. The operators performing the testing were non-

laboratorians representing healthcare professionals that may be encountered at

such sites. The study evaluated seven (7) panel members that were prepared using

cultured organisms in negative pooled clinical vaginal swab matrix (previously

determined to be negative for CT, NG, TV). The study was performed with negative

(unspiked), low positive (1X LoD), and moderate positive (3-5X LoD) samples.

A total of six (6) study operators (two operators at each site) tested the panel three

(3) times each testing day, over six (6) non-consecutive days. Three reagent lots were

used in the study. A summary of the results (count correct / total count) and %

agreement with expected results for each panel member by site and overall is

presented in the table below. The Visby Test demonstrated that untrained users can

perform testing accurately and reproducibly.

Visby Medical Sexual Health Test

Instructions for Use

Table 22. Summary of Reproducibility Study Results for the Visby Test

Panel Member

Site 1

Site 2

Site 3

Overall Agreement

Agreement

(count)

Agreement

(count)

Agreement

(count)

Agreement

(count)

95% CI

CT Moderate Positive

(64.0 EB/mL)

100.0%

(36/36)

100.0%

(36/36)

100.0%

(36/36)

100.0%

(108/108)

96.6%-100.0%

CT Low Positive

(16.0 EB/mL)

97.2%

(35/36)

100.0%

(36/36)

100.0%

(36/36)

99.1%

(107/108)

94.9%-99.8%

NG Moderate

Positive

(24.8 cfu/mL)

100.0%

(36/36)

100.0%

(36/36)

97.2%

(35/36)

99.1%

(107/108)

94.9%-99.8%

NG Low Positive

(6.2 cfu/mL)

100.0%

(36/36)

100.0%

(36/36)

100.0%

(36/36)

100.0%

(108/108)

96.6%-100.0%

TV Moderate

Positive

(4.8 troph/mL)

100.0%

(36/36)

100.0%

(36/36)

100.0%

(36/36)

100.0%

(108/108)

96.6%-100.0%

TV Low Positive

(1.2 troph/mL)

97.2%

(35/36)

97.2%

(35/36)

94.4%

(34/36)

96.3%

(104/108)

90.9%-98.6%

Negative

97.2%

(35/36)

100.0%

(36/36)

97.2%

(35/36)

98.1%

(106/108)

93.5%-99.5%

One CT Low Positive sample was unexpectedly positive for TV

One TV Low Positive sample was unexpectedly positive for CT

One Negative sample was unexpectedly positive for TV

EMC Compliance

The Visby Test was tested and found compliant in full to all requirements of IEC 60601-

1-2: 2014 +A1: 2020. The compliance for each emissions and immunity standard or

test specified by this collateral standard is provided in the tables below:

Table 23: Electromagnetic Emissions

Emissions Test

Compliance

Conducted Emissions Mains Terminal

Measurements

IEC 60601-1-2

CISPR 11 Group 1, Class B

Radiated Emissions Measurements

IEC 60601-1-2

CISPR 11 Group 1, Class B

Harmonic Current Emissions

IEC 61000-3-2

Voltage Fluctuations / Flicker Emissions

IEC 61000-3-3

Table 24: Electromagnetic Immunity

Immunity Test / Basic EMC Standard or

Test Method

IEC 60601-1-2: 2014 Test Levels

Electrostatic Discharge (ESD) Immunity

IEC 61000-4-2

Contact: +/- 8 kV

Air: +/- 2 kV; +/- 4 kV; +/- 8 kV; +/- 15

Radiated Immunity

IEC 61000-4-3

10 V/m over the frequency ranges of

80 MHz to 2,700 MHz, modulated with 1

kHz at 80% amplitude modulation

RF wireless communications

equipment: 385 MHz to 5785 MHz

Electrical Fast Transient/Burst Immunity

IEC 61000-4-4

Power Supply Lines: ±2 kV with a 100

kHz repetition rate

Surge Immunity

IEC 61000-4-5

Line to Line: ±0.5 kV, ±1 kV

Conducted Immunity

IEC 61000-4-6

3 Vrms: 1 kHz at 80% amplitude

modulation injection over the

frequency range 150 kHz to 80 MHz

6 Vrms: 1 kHz at 80% amplitude

modulation injection over the

frequency range 150 kHz to 80 MHz

Power Frequency Magnetic Field

Immunity (60 Hz)

IEC 61000-4-8

30 A/m at 60 Hz

Voltage Dips, Short Interruptions, and

Voltage Variations Immunity

IEC 61000-4-11

Dips:

0% of the rated voltage (100V and

240V) for 0.5 cycle and 1 cycle

70% of the rated voltage (100V and

240V) for 30 cycles at 60 Hz

Interruptions:

0 % of the rated voltage (100V and

240V) for 300 cycles at 60 Hz

Visby Medical Sexual Health Test

Instructions for Use

References

1. Gonorrhea detailed factsheet [Internet]. Centers for Disease Control and Prevention;

accessed updated 2021 July 22. Available from: https://www.cdc.gov/std/gonorrhea/

stdfactgonorrhea-detailed.htm.

2. Chlamydia detailed factsheet [Internet]. Centers for Disease Control and Prevention;

updated 2021 July 22. Available from: https://www.cdc.gov/std/chlamydia/

stdfactchlamydia-detailed.htm.

3. Trichomoniasis factsheet [Internet]. Centers for Disease Control and Prevention;

updated 2021 July 22. Available from:

https://www.cdc.gov/std/trichomonas/stdfacttrichomoniasis. htm.

4. Morré, S. A., Rozendaal, L., van Valkengoed, I. G., Boeke, A. J., van Voorst Vader, P. C.,

Schirm, J., de Blok, S., van Den Hoek, J. A., van Doornum, G. J., Meijer, C. J., & van Den

Brule, A. J. (2000). Urogenital Chlamydia trachomatis serovars in men and women with

a symptomatic or asymptomatic infection: an association with clinical manifestations?

JCM, 38(6), 2292–2296. https://doi.org/10.1128/JCM.38.6.2292-2296.2000

5. Centers for Disease Control and Prevention. Biosafety in microbiological and

biomedical laboratories. 6th Edition.

6. CLSI Publication M29. Protection of laboratory workers from occupationally acquired

infections; Approved Guideline. 4th Edition.

Index of Symbols

Symbol

Meaning

ISO 15223-1

Ref. Number

Power supply (9 V, 3.5 A DC, 31.5 W)

N/A

Catalog number

5.1.6

Do not reuse

5.4.2

Handle with care

5.3.1

Batch code

5.1.5

Caution

5.4.4

Consult instructions for use

5.4.3

Manufacturer

5.1.1

Expiration date

5.1.4

Temperature limitation

5.3.7

Humidity limitation

5.3.8

Biological risk

5.4.1

In vitro diagnostic medical device

5.5.1

Do not use if package is damaged

5.2.8

Nemko 61010

N/A

Prescription Use Only

N/A

Positive / negative controls

5.5.4 / 5.5.3

Atmospheric Pressure limitation

5.3.9

Visby Medical, Inc.

3010 North First Street

San Jose, CA 95134

Email: support@visby.com

Website: www.visby.com

Customer Support: 1-833-GoVisby (1-833-468-4729)

PS-300648 Rev C 05/24

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