QUIDEL QuickVue At-Home OTC COVID-19 Test Kit Instruction Manual

: June 6, 2024
: QUIDEL

QUIDEL QuickVue At-Home OTC COVID-19 Test Kit Instruction Manual

QUIDEL QuickVue At-Home OTC COVID-19 Test Kit Instruction
Manual

Healthcare Provider Instructions for Use
For Use Under an Emergency Use Authorization (EUA) Only For use with direct anterior nasal swab specimens
For In Vitro Diagnostic Use Only

INTENDED USE

The QuickVue At-Home OTC COVID-19 Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first six days of symptom onset. This test is also authorized for non-prescription home use with adult- collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first six days of symptom onset.

This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

The QuickVue At-Home OTC COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the QuickVue At-Home OTC COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with as a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.

Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider.

All results should be provided to a healthcare provider for public health reporting.

The QuickVue At-Home OTC COVID-19 Test is intended for non-prescription self- use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting. The QuickVue At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

SUMMARY AND EXPLANATION

SARS-CoV-2, also known as the COVID-19 virus, was first identified in Wuhan, Hubei Province, China in December 2019. This virus, as with the novel coronavirus SARS-1 and MERS, is thought to have originated in bats, however the SARS-CoV-2 may have had an intermediary host such as pangolins, pigs or civets.1 The WHO declared that COVID-19 was a pandemic on March 11, 2020, and human infection has spread globally, with hundreds of thousands of confirmed infections and deaths.2 The median incubation time is estimated to be 5.1 days with symptoms expected to be present within 12 days of infection.3 The symptoms of COVID-19 are similar to other viral respiratory diseases and include fever, cough and shortness of breath.4

PRINCIPLE OF THE PROCEDURE

The QuickVue At-Home OTC COVID-19 Test employs lateral flow immunoassay technology. Using this test allows for the rapid detection of nucleocapsid protein from SARS-CoV-2 as described in the intended use. This test does not differentiate between SARS-CoV and SARS-CoV-2.

To begin the test, a self-collected anterior nasal swab samples in individuals aged 14 and older or individuals between the age of 2 to 14 a swab collected by a parent or guardian is inserted into the Reagent Tube. This Reagent interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The Test Strip is added to the Reagent Tube now containing the specimen and Reagent Solution.

If the extracted specimen contains SARS-CoV-2 antigens, a pink-to-red Test Line, along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If SARS-CoV-2 is not present, or is present at very low levels, only a blue procedural Control Line will appear.

MATERIALS SUPPLIED WITH the QuickVue At-Home OTC COVID-19 Test Kit

Swabs – individually wrapped sterile foam swabs
Test Strips – individually packaged, single-use strips
Pre-filled Tubes
Tube Holder
Instruction Sheet

NOTE: This test comes in a 1 test, 2 test, 10 test, and 25 test quantity. The number of items supplied in the kit will vary depending on which kit was purchased.

MATERIALS NOT SUPPLIED WITH the QuickVue At-Home OTC COVID-19 Test Kit

Clock, Timer, or Stopwatch
Hand soap and water or hand sanitizer for cleaning your hands
Safety mask or other face covering
Gloves
Household waste basket

WARNINGS and PRECAUTIONS

For in vitro diagnostic use
Read the written instructions fully before starting the procedure
If uncertain how to proceed, contact Technical Assistance (see below)
Keep testing kit and kit components out of the reach of children and pets before and after use
Wear safety mask or other face covering when collecting anterior nasal swab specimen from child or another individual
Use of gloves is recommended when conducting
This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA)
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
The QuickVue At-Home OTC COVID-19 Test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first six days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first six days of symptom
The QuickVue At-Home OTC COVID-19 Test is also authorized for non-prescription home use with self- collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between
Do not open the test material until ready for use
Do not reuse the used Test Strip, Reagent Tubes, or
The Test Strip must remain sealed in the protective foil pouch until The user should never open the foil pouch of the Test Strip exposing it to the ambient environment until the Test Strip is ready for immediate use. If the test strip is open for an hour or longer, invalid test result may occur.
Do not touch swab tip when handling the
When collecting an anterior nasal swab sample, only use the nasal swab(s) provided in the
Inadequate or inappropriate specimen collection may yield false negative test
To obtain accurate results, you must follow the Package Insert
Testing should be performed in an area with adequate
Individuals with color-impaired vision may not be able to adequately interpret test results
Dispose of all materials in household
Do not use the QuickVue At-Home OTC COVID-19 Test Kit after its expiration
Wash hands thoroughly or use hand sanitizer after handling
The Reagent Solution contains harmful chemicals (see table below). If the solution contacts the skin or eye, flush with copious amounts of water. If irritation persists, seek medical advice: https://www.poisoorg/contact-us or 1-800-222-1222

Hazardous Ingredients for Reagent Solution

Chemical Name/CAS| Harms (GHS Code) for each ingredient| Concentration
Sodium Phosphate Monobasic Monohydrate/10049-21-5| Causes skin irritation (H315) Causes serious eye irritation (H319)

May cause respiratory irritation (H335)

| 0.7%
Sodium Phosphate Dibasic Anhydrous/7558-79-4| Causes serious eye damage (H318) Causes serious eye irritation (H319)| 0.7%
C12-14-Alkyldimethyl- betaines/ 66455-29-6| Causes severe skin burns and eye damage (H314) Causes serious eye damage (H318)

Causes skin irritation (H315) Causes serious eye irritation (H319)

| 0.03%
ProClin® 300| Harmful if swallowed (H302) Harmful if inhaled (H332)

Causes severe skin burns and eye damage (H314) May cause an allergic skin reaction (H317)

| 0.03%
EDTA Tetrasodium Salt/64-02-8| Harmful if swallowed (H302) Causes serious eye damage (H318) Causes serious eye irritation (H319) Harmful if inhaled (H332)

May cause respiratory irritation (H335)

May cause damage to organs (H371), single exposure

| 0.2%

KIT STORAGE and STABILITY

You can store the testing kit at room temperature in a place out of direct sunlight and out of reach of children until its expiration date. After that date the kit should be discarded in household waste.

PLANNING

If you are performing the test for more than one person complete all of the steps for one person’s test before starting the next collection. This will help avoid possible mix-ups of specimens and test results. Take time to review the product information, quick reference instructions and training material prior to testing.

If the test is being used for testing individuals without symptoms or other epidemiological reasons to suspect COVID-19, testing should be scheduled twice over two (or three) days with at least 24 hours (and no more than 48 hours) between tests.

BEFORE STARTING

Read these instructions carefully
Complete the steps in order
Gather all kit components required for running the test
If collecting a sample or performing the test on another individual, a face covering and gloves should be worn
Before starting the test, wash your hands with soap and water or use hand sanitizer

TEST PROCEDURE

Test materials and clinical specimens must be at room temperature before beginning the assay. Use of gloves is recommended when conducting testing.

QUIDEL QuickVue At-Home OTC COVID-19 Test Kit Instruction Manual - TEST
PROCEDURE

COLLECTING A SAMPLE

Hold the swab approximately halfway up the handle and gently insert the swab ½ to ¾ of an inch into the nostril, depending on the size of the person’s nose
Rub the swab around the inside wall of each nostril at least 4 times. Take approximately 15 seconds to collect the This is done with the same swab.

Note: Please wear a face covering if collecting specimen from an individual aged 2 years or older. With children, the maximum depth of insertion into the nostril may be less than ¾ of an inch and you may need to have a second person to hold the child’s head while collecting. Samples should be processed as soon as possible after collection.

**Note: Inadequate or inappropriate specimen collection, may yield false negative test results**

**** PERFORMING THE TEST

Immediately place the swab into the open pre-filled Be sure the swab is touching the bottom of the tube. Stir or twirl swab 3 or 4 times.

![QUIDEL QuickVue At-Home OTC COVID-19 Test Kit Instruction Manual

PERFORMING THE TEST](https://manuals.plus/wp-content/uploads/2022/03/QUIDEL- QuickVue-At-Home-OTC-COVID-19-Test-Kit-Instruction-Manual-PERFORMING-THE- TEST-3.jpg)

INTERPRETATION OF RESULTS

*Positive Result:**

At 10 minutes, the appearance of ANY shade of pink-to-red Test Line AND the appearance of a blue procedural Control Line indicates a positive Test Result for the presence of SARS-CoV-2 antigen. Results can only be read for an additional five (5) minutes after being remove from the tube at the 10-minute read time. Do not read the Test Strip more than fifteen minutes after placing into pre-filled tube.
*A positive result does not rule out co-infections with other pathogens
__ Look closely! The test strip on the far right is a positive result. Even if you see a very faint, pink Test Line and a blue Control Line, this is a POSITIVE Test Result.

C = Control Line
T = Test Line

Negative Result:**

At 10 minutes, the appearance of ONLY the blue procedural Control Line indicates SARS antigen was note detected. Results can only be read for an additional five (5) minutes after the 10-minute read time. Do not read the Test Strip more than fifteen minutes after placing into pre-filled tube.

For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such in an individual with as a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection.

Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.

** A negative result does not exclude SARS-CoV-2 infection. Negative results should be treated as presumptive and may need to be confirmed by a molecular assay.

Invalid Result:

If at 10 minutes, the blue Control Line does not appear, even if any shade of pink-to- red Test Line appears, the result is invalid.
If at 10 minutes, the background color does not clear and it interferes with the reading of the test, the result is also invalid.
If the Test Result is invalid, a new swab should be collected, and the test should be performed again with a new pre-filled tube and Test Strip.

LIMITATIONS

Testing for asymptomatic individuals should be performed at least twice over three days, with at least twenty-four hours and no more than 48 hours between You may need to purchase additional tests to perform this serial (repeat) testing.
There is a higher chance of false negative results with antigen tests than with laboratory-based molecular This means that there is a higher chance this test will give you a negative result when you have COVID-19.
Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any
The performance of this test has not yet been clinically validated for use in patients without signs and symptoms of respiratory infection or for serial screening applications, and performance may differ in these
The test is intended for direct anterior nasal swab specimens Using another sample collection device or method may cause false results.
The contents of this kit are to be used only for the qualitative detection of SARS-CoV-2 antigens from anterior nasal swab
A negative tests result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected improperly.
This test detects both viable (live) and non-viable, SARS-CoV-2. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same
Failure to follow the Performing the Test and Interpretation of Results may adversely affect test performance and/or invalidate the Test Results.
Positive Test Results do not rule out co-infections with other
Negative results should be treated as presumptive, and confirmation with another SARS-COV-2 assay, if necessary, should be done.
If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is Please discuss with your healthcare provider.
The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between January 2021 and March 2021. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time. The performance of this test has not yet been clinically validated for use in patients without signs and symptoms of respiratory infection, or for serial screening applications and performance may differ in these

CLINICAL PERFORMANCE*

The QuickVue At-Home OTC COVID-19 Test was compared to a Reference Extracted EUA SARS-CoV-2 RT-PCR Assay using fresh self-collected or parent/guardian collected anterior nasal swab specimens and healthcare provider collected anterior nasal swab specimens. Symptomatic subjects were enrolled within six days of the onset of symptoms from a multi-site prospective clinical study. The subjects included in the study were provided a Quick Reference Instruction (QRI) and the test kit. No additional training or instructions were provided. Testing occurred in subjects’ home, a private, home-like environment within an outpatient clinic, or in subjects’ cars.

Three hundred fifty (350) patients (306 symptomatic, 44 asymptomatic) were enrolled in the on-going prospective clinical study at six (6) collection sites. The healthcare collected swabs were sent on cold packs to the Quidel laboratory in Athens, Ohio for EUA SARS-CoV-2 RT-PCR testing. The Reference Extracted SARS-CoV- 2 RT-PCR Assay testing was performed on the swabs according to the device’s instructions for use.

The table below summarizes the data from the one hundred and sixty-one specimens: Patient Demographics

Patient demographics (age, elapsed time from date of on-set) for the combined data are provided below.

The specimen positivity breakdown based on age of the patient:

Age

| QuickVue At-Home OTC COVID-19 Test (N=350)
---|---
Total #| Total Positive| Prevalence
£ 5 years| 6| 0| 0%
6 to 21 years| 84| 9| 10.7%
22 to 59 years| 249| 70| 28.1%
³ 60 years| 11| 4| 36.4%

The specimen positivity breakdown based on days post onset:

Days Post Symptom Onset	QuickVue At-Home OTC COVID-19 Test
# Specimens Tested	# Positive Specimens
0	32
1	71
2	86
3	49
4	31
5	18
6	9
>6	10
Asymptomatic	44

Comparison of QuickVue At-Home OTC COVID-19 Test and an authorized EUA Molecular comparator assay with anterior nasal swabs

Number

Tested

| True

Positive

| False

Positive

| True

Negative

| False

Negative

| PPA%| NPA%| PPA 95% CI| NPA 95% CI
350| 81| 2| 251| 16| 83.5| 99.2| 74.9 to 89.6| 97.2 to 99.8

* The performance of this test has not yet been clinically validated for use in patients without signs and symptoms of respiratory infection, or for serial screening applications and performance may differ in these populations.

ANALYTICAL PERFORMANCE

Limit of Detection

The Limit of Detection (LoD) of the QuickVue At-Home OTC COVID-19 Test was determined using limiting dilutions of heat-inactivated SARS-CoV-2 (ZeptoMetrix 0810587CFHI). The ZeptoMetrix material is a preparation of SARS- Related Coronavirus 2 (SARS-CoV-2), isolate USA-WA1/2020, that has been inactivated by heating at 65°C for 30-minutes. The material was supplied frozen at a concentration of 9.55 x106 TCID50/mL.

The study to determine the QuickVue At-Home OTC COVID-19 Test LoD was designed to reflect the assay when using direct swabs. Individual foam swabs (the same swab that is provided with the kit) were placed into the limiting dilutions. The swabs were then processed according to the QuickVue At Home COVID-19 Test. The results were recorded for each swab in the study.

The LoD was determined in three steps:

LoD Screening
10-fold dilutions of the heat inactivated virus were made in negative nasal matrix in saline and processed for each study as described above. These dilutions were tested in triplicate. The lowest concentration demonstrating 3 of 3 positives was chosen for LoD range finding. Based on this testing, the concentration chosen was TCID50 per mL of 9.55 x104.
LoD Range Finding
A 1:3 and 1:5 dilution was made of the 9.55× 104 TCID50 per mL dilution from the previous study yielding concentrations of 3.18× 104 TCID50 per mL and 1.91× 104 TCID50 per mL, respectively. (Note: 9.55× 103 TCID50 per mL was previously determined to be negative (0/3)).
LoD Confirmation
The concentration 1.91 x104 dilution was tested twenty (20) times. Twenty (20) of twenty (20) results were positive. Based on this testing the concentration was confirmed as TCID50 per mL of 1.91 x104.

Analytical Reactivity/Inclusivity

The analytical reactivity of the monoclonal antibodies targeting SARS-CoV-2 in the QuickVue At-Home COVID- 19 Test were evaluated with a currently available SAR-CoV-2 strain (see table below).

2019-nCoV Strain/Isolate	Source/Sample Type	Concentration
USA-WA1/2020	ZeptoMetrix 0810587CFHI	9.55 x106 TCID50/mL

Cross-Reactivity

Cross-reactivity of the monoclonal antibodies used for the detection of SARS- CoV-2 was evaluated by testing various microorganisms (13) and viruses (16) that may potentially cross-react with the QuickVue At-Home COVID-19 Test. Each organism and virus were tested in triplicate. The final concentration of the organisms and viruses are documented in the table below:

Cross-Reactivity/Interference of QuickVue At-Home OTC COVID-19 Test

Arabia_2014

|

Isolate

|

3.55e5 U/mL

|

No Cross-Reactivity

|

No Interference

Caledonia/20/99

| Isolate| 3.55e5 U/mL| No Cross-Reactivity| No Interference

Cross-Reactivity/Interference of QuickVue At-Home OTC COVID-19 Test

Virus/Bacteria/Parasite| Strain| Source/

Sample type

| Concentration| Cross-Reactivity

**Results***

| Interference

**Results***

Virus

| Type A (3/2015

Isolate #3)

Testing was performed in triplicate
** CCU/mL is Color Changing Units as calculated according to a modified Reed- Muench method based on dilutions which produced a color change in the broth.
* The stock is inactivated virus with no quantitation provided.
** IFU/mL is infectious units per millilitre

Hook Effect :

As part of the LoD study the highest concentration of heat-inactivated SARS- CoV-2 stock available (TCID50 per mL of 9.55 x106) was tested. There was no Hook effect detected.

Endogenous Interference Substances Studies:
A study was performed to demonstrate that twenty (20) potentially interfering substances that may be found in the upper respiratory tract do not cross-react or interfere with the detection of SARS-CoV-2 in the QuickVue At- Home OTC COVID-19 Test.

Potentially Interfering Substances for QuickVue At-Home OTC COVID-19 Test

Substance| Active Ingredient| Concentration| Cross- Reactivity

**Results***

| Interference

**Results***

Rinse

| Sodium chloride, Sodium

bicarbonate

Testing was performed in triplicate

ASSISTANCE

If you have any questions regarding the use of this product, please call QuickVue at Home product support 833-QUICKVUE (833-784-2588). Test system problems may also be reported to the FDA through the MedWatch medical products reporting program (phone: 800.FDA.1088; fax: 800.FDA.0178; http://www.fda.gov/medwatch).

Quidel and QuickVue are registered trademarks of Quidel Corporation. Any other trademark contained in this document is the property of its respective owner and its use herein does not imply sponsorship or endorsement of any products or services.

REFERENCES

Baker, S., Frias, L., and Bendix, A. Coronavirus live updates: More than 92,000 people have been infected and at least 3,100 have died. The US has reported 6 deaths. Here’s everything we know. Business Insider. March 03,
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
Clinical and Laboratory Standards Institute. Viral Culture; Approved Guidelines. CLSI document M41-A [ISBN 1562386239] Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA
Lauer, A., et. al. The incubation period of Coronavirus disease 2019 (COVID-19) from publicly reported confirmed cases: estimation and application, Ann Intern Med. 2020

(REF) 20431 – QuickVue At-Home OTC COVID-19, 1 Test Kit
(IVD) 20402 – QuickVue At-Home OTC COVID-19, 2 Test Kit
20427 – QuickVue At-Home OTC COVID-19, 10 Test Kit
20398 – QuickVue At-Home OTC COVID-19, 25 Test Kit

Quidel Corporation
10165 McKellar Court
San Diego, CA 92121 USA
quidel.com