IMMUVIEW COVID-19 Antigen Home Test Instruction Manual

IMMUVIEW COVID-19 Antigen Home Test

INTENDED USE

The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
This test is 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 (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS- CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab 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. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results 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 measures such as isolating from others and wearing masks. 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.

Individuals 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.
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting and to receive appropriate medical care. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.

The ImmuView® COVID-19 Antigen Home Test is intended for non-prescription self-use and/or as applicable an adult lay user testing another person 2 years of age or older in a non-laboratory setting. The ImmuView® COVID-19 Antigen Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.

QUALITY CONTROL
Internal Control: This test contains a built-in control feature, the C line. If the C line does not develop after sample application, the result is invalid. Review the entire procedure and repeat the test with a new device.

EXPLANATION OF TEST

SARS-CoV-2 belongs to the broad family of coronaviruses which are capable of causing illnesses ranging from the common cold to more severe diseases1. SARS- CoV-2 infections cause COVID-19 disease resulting in a wide range of clinical symptoms, ranging from asymptomatic to fever, tiredness, and dry cough, and possibly leading to severe sickness and even death. Most patients recover without special treatment. According to recent data, approximately 15-20% of infected individuals become seriously ill and develop difficulty breathing2. The elderly and those with underlying medical problems, such as high blood pressure, heart problems or diabetes are more likely to develop serious illness2.

Human-to-human transmission of the virus has been confirmed and occurs primarily via respiratory droplets from coughs and sneezes within a range of about six feet (1.8 m)3. Viral RNA has also been found in stool samples from patients. It is possible that the virus can be infectious even during the incubation period, but this has not yet been proven4.
The gold standard laboratory method for detecting COVID-19 is PCR. However, this method requires sophisticated equipment and highly trained laboratory technicians. The ImmuView® COVID-19 Antigen Home Test is an easy-to-use assay that can be performed by lay populations in diverse settings. The ImmuView® COVID-19 Antigen Home Test detects the presence of antigens from the SARS- CoV-2 virus within the first seven days of the onset of symptoms. Test results can be interpreted after 15 minutes. Results should not be interpreted after 30 minutes.

TEST PRINCIPLE

The ImmuView® COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a colored conjugate pad containing anti-SARS-CoV-2 antibodies conjugated with colloidal gold (antibody conjugates) and 2) a nitrocellulose membrane strip containing a test line (Ag line) and a control line (C line). The test line is pre-coated with anti-SARS- CoV-2 antibodies and the C line is pre-coated with control antibodies. The specimen is collected with a nasal swab and the SARS-CoV-2 antigen is extracted from the swab with an extraction buffer. When applied to the sample well, the extracted specimen migrates across the test strip by capillary action. SARS-CoV-2 antigen, if present in the extract, binds to the antibody conjugates, and the immunocomplex is then captured on the membrane by the pre- coated anti-SARS-CoV-2 antibody, forming a colored Ag line that indicates a COVID-19 positive test result. The test contains an internal control (C line), which should exhibit a colored line regardless of color development on the Ag line. If the C line does not develop, the test result is invalid and the specimen must be retested with a new device.

MATERIALS PROVIDED

Contents of 2 Test Kit:| x2 “Buffer and Nozzle” pouches| x2 Cassette Pouches| x2 Swabs| x1 Instructions for Use
---|---|---|---|---
Contents of 5 Test Kit:| x5 “Buffer and Nozzle” pouches| x5 Cassette Pouches| x5 Swabs| x1 Instructions for Use
Contents of 20 Test Kit:| x20 “Buffer and Nozzle” pouches| x20 Cassette Pouches| x20 Swabs| x4 Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED

• Watch or timer
• Tissues
• Soap and water or hand sanitizer
• Mirror (optional)

TEST PROCEDURE

• If testing another person, always wear gloves. If you are testing more than one person, always clean the test space and wash your hands and change gloves between each test.
• Do not use the kit if the items are damaged, missing or expired. Use buffer and cassette within 30 minutes of opening pouches. For 2, 5 and 20 test kits, do not discard the kit box until all tests are used.
• Children aged 14 to 17 may self-test with adult supervision. Do not touch your cheeks, teeth, gums or any other surfaces with the fabric tip of the swab, or it might contaminate your sample. DO NOT touch the fabric tip of the swab with your hands.

BEFORE OPENING THE TEST

1. Step 1
   You will need (not included in the kit)

   • Watch or timer
   • Tissues
   • Soap and water or hand sanitizer
   • Mirror (optional)

2. Step 2
   Clean and dry a flat, well-lit surface, such as a table or counter top.

3. Step 3
   Blow your nose and discard the tissues.

4. Step 4
   Wash your hands and DRY them thoroughly.
   PREPARE FOR TESTING

5. Step 5
   Remove all items needed for 1 test. Check that the seal is still intact in all items.
   Check the expiration dating of the kit. For current information on the expiration dating of the product please visit: https://www.fda.gov/medical- devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic- tests#list

6. Step 6
   Open the pouch labeled “Buffer and Nozzle’:

7. Step 7
   Push in the perforated circle on the kit box and place the buffer tube. Slowly peel off the buffer tube seal. Place the open tube in the rack.

8. Step 8
   Open the swab packaging and hold the swab by its handle. DO NOT touch the fabric tip of the swab.
   COLLECT SAMPLE

9. Step 9

   • Carefully insert fabric tip of the swab 1/2 to 3/4 of an inch into first nostril. With children, the maximum depth of insertion into the nostril may be less than 3/4 of an inch, and you may need to have a second person to hold the child’s head while swabbing.
   • DO NOT insert the swab any deeper if you feel strong resistance or pain. If self-testing, use a mirror to help.
   • Slowly rub swab in a complete circle around the inside of the nostril at least 5 times.
   • Using the SAME SWAB, repeat process in the second nostril.
   • Children 2-14 years old should be tested by an adult (wear a face cover when swabbing others)
     PROCESS THE SWAB SAMPLE

10. Step 10
    Remove the buffer tube from the rack. Insert the fabric tip of the swab into the tube. Swirl the swab in the liquid for 15 seconds.

11. Step 11
    Remove the swab from the tube while squeezing tube into the swab tip, to press out excess liquid. Place the tube back on the tube rack.

12. Step 12
    Insert the nozzle into the tube while holding the tube with your other hand. It should fit snug like a cork.
    TEST THE SAMPLE

13. Step 13
    Open the pouch labeled “COVID-19 Antigen Home Test” and remove the test cassette. Do not use after the test cassette has been opened for more than 30 minutes. Lay the cassette on clean, flat, well-lit surface.

14. Step 14
    Invert the buffer tube over the cassette and gently squeeze to slowly add 3 drops of the liquid into the sample well (S), avoiding forming bubbles. Immediately start timing 15 minutes and wait. DO NOT move the cassette during the test.
    READ THE RESULT

15. Step 15
    Read result after 15 minutes. You must read the result after 15 minutes, but not past 30 minutes. For result interpretation, please see the “INTERPRETATION Of ASSAY RESULTS” section below.
    SAFELY DISPOSE OF USED TEST

16. Step 16
    When testing is completed, dispose of used items (except Instructions for Use) in a trash can (not recycling) or according to your local guidelines. Thoroughly wash or sanitize your hands and any surfaces and items used during testing.

INTERPRETATION OF ASSAY RESULTS

POSITIVE
If the Control (C) line and the antigen (Ag) line are visible, the test is positive. Any faint (red) test (Ag) line with the control line (C) should be read as positive.

NEGATIVE
If the Control (C) line is visible, but the antigen (Ag) line is not visible, the test is negative.

INVALID
If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test device. For additional information on result interpretation, please see the section below.

COVID-19 Positive (+)
If the Control (C) line and the antigen (Ag) line are visible, the test is positive. Any faint (red) antigen (Ag) line with the control line (C) should be read as positive.
Repeat testing does not need to be performed if patients have a positive result at any time.

A positive test result means that the virus that causes COVID-19 was detected in the sample, and it is very likely the individual has COVID-19 and is contagious. Please contact the patient’s doctor/primary care physician (if applicable) and the local health authority immediately and instruct your patient to adhere to the local guidelines regarding self-isolation. There is a very small chance that this test can give a positive result that is incorrect (a false positive). Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow up care with their physician or healthcare provider as additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.

COVID-19 Negative (-)
If the Control (C) line is visible, but the antigen (Ag) line is not visible, the test is negative. To increase the chance that the negative result for COVID-19 is accurate, you should:

• Test again in 48 hours if the individual has symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if the individual does not have symptoms on the first day of testing.

A negative test result indicates that the virus that causes COVID-19 was not detected in the sample. A negative result does not rule out COVID-19. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR tests. If the test is negative but COVID-19-like symptoms, e.g., fever, cough, and/or shortness of breath continue, follow up testing for SARS-CoV-2 with a molecular test or testing for another respiratory disease should be considered. If applicable, seek follow up care with the primary health care provider. All negative results should be treated as presumptive and confirmation with a molecular assay may be necessary if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Negative results 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.

Invalid
If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test device.

Result Interpretation for Serial Testing
Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results for COVID-19.

Status on First Day of Testing| First Result Day 1| Second Result Day 3| Third Result Day 5| Interpretation
---|---|---|---|---
With Symptoms| Positive| N/A| N/A| Positive for COVID-19
Negative| Positive| N/A| Positive for COVID-19
Negative| Negative| N/A| Negative for COVID-19
Without Symptoms| Positive| N/A| N/A| Positive for COVID-19
Negative| Positive| N/A| Positive for COVID-19
Negative| Negative| Positive| Positive for COVID-19
Negative| Negative| Negative| Negative for COVID-19

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.

STORAGE AND STABILITY

1. In a dry place, at 35°F-86°F (2°C-30°C).
2. Keep away from direct sunlight and do not store it in a freezer.
3. If you stored the kit in an area colder than 59°F (10°C), leave it at room temperature for 30 minutes before starting the test.

WARNINGS AND PRECAUTIONS

1. Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.
2. In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. 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.
3. Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing. If you have had symptoms longer than 5 days you should consider testing at least three times over five days with at least 48 hours between tests.
4. If you have had symptoms for longer than 7 days you should consider testing at least three times over five days with at least 48 hours between tests.
5. An anterior nasal swab sample can be self-collected by an individual age 14 years and older. Children age 2 to 13 years should be tested by an adult.
6. Do not use on anyone under 2 years of age.
7. Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
8. Do not use if any of the test kit contents or packaging is damaged.
9. Test components are single-use. Do not re-use.
10. Do not use kit past its expiration date.
11. Do not touch the swab tip.
12. Once opened, the test card should be used within 30 minutes.
13. Do not read test results before 15 minutes or after 30 minutes. Results read before 15 minutes or after 30 minutes may lead to a false positive, false negative, or invalid result.
14. Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table below). If the solution contacts your [e.g., skin, eyes, nose, or mouth], flush with large amounts of water. If irritation persists, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.
    Chemical Name| Harms (GHS Code) for each ingredient at stock for reference only:| Concentration
    ---|---|---
    Tergitol 15 S-9| H302, H332, H315, H318, H401| 0.4%
    ProClin 300| H302, H312, H314, H317, H332, H411| 0.1%
    Sodium Azide| H300, H400, H410| 0.095%
15. For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
16. For the most up to date information on COVID-19, please visit: https://www.cdc.gov/coronavirus/2019-ncov/index.html.
17. For detailed instructions, please visit: https://immuviewathome.com

PERFORMANCE CHARACTERISTICS

Clinical Performance

Performance in Nasal Swab Specimens
The clinical performance of the ImmuView® COVID-19 Antigen Home Test was evaluated at 6 clinical sites in nasal swab specimens collected from symptomatic subjects suspected of COVID-19. Two nasal swabs were collected from each subject, one for testing by the ImmuView® COVID-19 Antigen Home Test and one for testing by commercially available real-time Polymerase Chain Reaction (RT-PCR) assay EUA authorized for the detection of SARS-CoV-2, used as the reference method for this study. The combined performance of the ImmuView® COVID-19 Antigen Home Test in these studies is shown in the table below:
Performance of ImmuView® COVID-19 Antigen Home Test in symptomatic subjects

Serial Testing Study Conducted by the National Institutes of Health (NIH)
A prospective clinical study was conducted between January 2021 and May 2022 as a component of the Rapid Acceleration of Diagnostics (RADx) initiative from the National Institutes of Health (NIH). A total of 7,361 individuals were enrolled via a decentralized clinical study design, with a broad geographical representation of the United States. Per inclusion criteria, all individuals were asymptomatic upon enrollment in the study and at least 14 days prior to it and did not have a SARS-CoV-2 infection in the three months prior to enrollment. Participants were assigned to one of three EUA authorized SARS- CoV-2 OTC rapid antigen tests to conduct serial testing (every 48 hours) for 15 days. If an antigen test was positive, the serial-antigen testing result is considered positive.

At each rapid antigen testing time point, study subjects also collected a nasal swab for comparator testing using a home collection kit (using a 15-minute normalization window between swabs). SARS-CoV-2 infection status was determined by a composite comparator method on the day of the first antigen test, using at least two highly sensitive EUA RT-PCRs. If results of the first two molecular test were discordant a third highly sensitive EUA RT-PCR test was performed, and the final test result was based upon the majority rule.

Study participants reported symptom status throughout the study using the MyDataHelps app. Two-day serial antigen testing is defined as performing two antigen tests 36 – 48 hours apart. Three-day serial antigen testing is defined as performing three antigen tests over five days with at least 48 hours between each test.
Out of the 7,361 participants enrolled in the study, 5,609 were eligible for analysis. Among eligible participants, 154 tested positive for SARS-CoV-2 infection based on RT-PCR, of which 97 (62%) were asymptomatic on the first day of their infection, whereas 57 (39%) reported symptoms on the first day of infection. Pre-symptomatic subjects were included in the positive percent agreement (PPA) of asymptomatic individuals, if they were asymptomatic on the first day of antigen testing, regardless of whether they developed symptoms at any time after the first day of testing.
Performance of the antigen test with serial testing in individuals is described in Table 1.2.1
Table 1.2.1: Data establishing PPA of COVID-19 antigen serial testing compared to the molecular comparator single day testing throughout the course of infection with serial testing. Data is from all antigen tests in study combined.

DAYS AFTER FIRST PCR POSITIVE TEST RESULT| ASYMPTOMATIC ON FIRST DAY OF TESTING| SYMPTOMATIC ON FIRST DAY OF TESTING
---|---|---
Ag Positive / PCR Positive (Antigen Test Performance % PPA)
1 Test| 2 Tests| 3 Tests| 1 Test| 2 Tests| 3 Tests
0| 9/97 (9.3%)| 35/89 (39.3%)| 44/78 (56.4%)| 34/57 (59.6%)| 47/51 (92.2%)| 44/47 (93.6%)
2| 17/34 (50.0%)| 23/34 (67.6%)| 25/32 (78.1%)| 58/62 (93.5%)| 59/60 (98.3%)| 43/43 (100%)
4| 16/21 (76.2%)| 15/20 (75.0%)| 13/15 (86.7%)| 55/58 (94.8%)| 53/54 (98.1%)| 39/40 (97.5%)
6| 20/28 (71.4%)| 21/27 (77.8%)| 16/18 (88.9%)| 27/34 (79.4%)| 26/33 (78.8%)| 22/27 (81.5%)
8| 13/23 (56.5%)| 13/22 (59.1%)| 4/11 (36.4%)| 12/17 (70.6%)| 12/17 (70.6%)| 7/11 (63.6%)
10| 5/9 (55.6%)| 5/8 (62.5%)| | 4/9 (44.4%)| 3/7 (42.9%)|

1. Test = one (1) test performed on the noted days after first PCR positive test result. Day 0 is the first day of documented infection with SARS-CoV-2.
2. Tests = two (2) tests performed an average of 48 hours apart. The first test performed on the indicated day and the second test performed 48 hours later.
3. Tests = three (3) tests performance an average of 48 hours apart. The first test performed on the indicated day, the second test performed 48 hours later, and a final test performed 48 hours after the second test.

Analytical Performance

• Analytical Sensitivity (Limit of Detection, LoD)
  The LoD of the ImmuView® COVID-19 Antigen Home Test was determined by evaluating a serial dilution of inactivated SARS-CoV-2 (USA-WA1/2020, ZeptoMetrix, 0810587UV). Multiple negative nasal swab specimens were eluted in buffer and combined to create clinical negative matrix pools to be used as the diluent. Inactivated SARS-CoV-2 virus lysate was diluted in this matrix to generate virus dilutions for testing. Each nasal swab was spiked with 50 μL of each virus dilution, extracted with ImmuView® COVID-19 Antigen Home Test extraction buffer and tested following the product IFU. The assay LoD was determined as the lowest concentration that was detected ≥ 95% of the time.
  The LoD of the ImmuView® COVID-19 Antigen Home Test in nasal swab matrix was determined to be 421.3 TCID50/mL. The LoD per swab, based upon 50μl pipetted onto the swabs, is 21.1 TCID50/Swab.

• Analytical Specificity (Cross-Reactivity and Microbial Interference)
  The analytical specificity of the ImmuView® COVID-19 Antigen Home Test was evaluated by testing commensal and pathogenic microorganisms that may be present in the nasal cavity. Each of the organisms was tested in triplicate in the absence or presence of 2-3X LoD inactivated SARS-CoV-2 virus (USA- WA1/2020, ZeptoMetrix, 0810587UV). No cross-reactivity (except SARS- coronavirus) or microbial interference was seen with the following microorganisms when tested at the concentration presented in the table below:Potential Cross-Reactant| Concentration| Cross-Reactivity (YES/NO)| Microbial Interference (YES/NO)
  ---|---|---|---
  SARS-coronavirus NP antigen| 25 µg/mL1| Yes (3/3 POSITIVE)| NO (3/3 POSITIVE)
  MERS-coronavirus| 1.17 x 104 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Human coronavirus HKU1 NP antigen| 66 µg/mL2| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Human coronavirus 229E| 1.26 x 105 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Human coronavirus OC43| 1.70 x 104 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Human coronavirus NL63| 1.17 x 104 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Adenovirus| 7 x 105 NIU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Human Metapneumovirus (hMPV)| 3.80 x 105 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Parainfluenza virus 1| 1.01 x 105 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Parainfluenza virus 2| 1.6 x 105 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Parainfluenza virus 3| 1.6 x 105 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Parainfluenza virus 4| 1.15 x 105 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Influenza A| 1.0 x 105 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Influenza B| 7.3 x 105 CEID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Enterovirus| 2.8 x 105 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Respiratory syncytial virus| 3.55 x 104 TCID50/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Rhinovirus| 2.2 x 105 PFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Haemophilus influenzae| 5.2 x 105 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Streptococcus pneumoniae| 1.47 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Streptococcus pyogenes| 3.6 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Candida albicans| 4.5 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Pooled human nasal wash – representative of normal respiratory microbial flora| N/A| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Bordetella pertussis| 1.95 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Mycoplasma pneumoniae| 3.0 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Chlamydophila pneumoniae| 1.4 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Legionella pneumophila| 3.68 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Staphylococcus aureus| 1.38 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Staphylococcus epidermidis| 9.27 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Mycobacterium tuberculosis| >1 x 104 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)
  Pneumocystis jirovecii (PJP)| 3.45 x 106 CFU/mL| NO (3/3 NEGATIVE)| NO (3/3 POSITIVE)

Endogenous Interfering Substances
The following potentially interfering substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity were evaluated with the ImmuView® COVID-19 Antigen Home Test at the concentrations listed in the following table and were found not to affect test performance for detection of both positive and negative specimens:

Substance| Concentration| Interference in Positive Samples (YES/NO)| Interference in Negative Samples (YES/NO)
---|---|---|---
Whole Blood| 4%| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Mucin| 0.5%| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Chloraseptic (Menthol / Benzocaine)| 15% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Naso GEL (NeilMed) (Saline)| 5% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
CVS Nasal Drops (Phenylephrine)| 15% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Afrin (Oxymetazoline)| 15% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
CVS Nasal Spray (Cromolyn)| 15% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Zicam| 5% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Homeopathic (Alkalol)| 1:10 Dilution| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Sore Throat Phenol Spray| 15% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Tobramycin| 4 µg/mL| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Mupirocin| 10 mg/mL| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Fluticasone Propionate| 5% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Tamiflu (Oseltamivir Phosphate)| 5 mg/mL| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Biotin| 100 µg/mL| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Body & Hand Lotion (Aveeno)| 0.5% w/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Body Lotion (1.2% dimethicone) (Aveeno)| 0.5% w/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Hand Sanitizer with Aloe (70% ethyl alcohol (CVS)| 5% v/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Hand Sanitizer Cream Lotion (Vaseline)| 10% w/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Hand Sanitizer, fast drying (80% ethanol) (NatureWell)| 15% w/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)
Hand Soap Liquid Gel (Softsoap)| 10% w/v| NO (3/3 POSITIVE)| NO (3/3 NEGATIVE)

Hook Effect
No high dose hook effect was observed when tested with up to a concentration of 9.14 × 105 TCID50/mL of inactivated SARS-CoV-2 Virus (USA-WA 1/2020, ZeptoMetrix, 0810587UV) with the ImmuView® COVID-19 Antigen Home Test.

Flex Studies
A robust use of ImmuView® COVID-19 Antigen Home Test was demonstrated by eight (8) flex studies as follows:

1. Device orientation
2. Cassette moving during analysis
3. Swab elution variability
4. Sample volume variability
5. Result reading time variability
6. Extraction buffer volume variability
7. Lighting
8. Temperature and humidity

LIMITATIONS OF TEST

1. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between March, 2022 and August, 2022. The clinical performance has not been established for 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.
2. The performance of the ImmuView® COVID-19 Antigen Home Test was evaluated using the procedures provided in Instruction for Use (IFU) only. Modifications to these procedures may alter the performance of the test.
3. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 as compared to a molecular test, especially in samples with low viral load.
4. All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary.
5. Negative test results are not indicative of the presence/absence of other viral or bacterial pathogens.
6. If the patient continues to have symptoms of COVID-19, and both the patient’s first and second tests are negative, the patient may not have COVID-19, however additional follow-up may be needed.
7. If the test is positive, then proteins from the virus that causes COVID-19 have been found in the sample and the individual likely has COVID-19.
8. This test is read visually and has not been validated for use by those with impaired vision or color-impaired vision.
9. Incorrect test results may occur if a specimen is incorrectly collected or handled.
10. This test detects both viable (live) and nonviable SARS-CoV-2. Test performance depends on the amount of virus (antigens) in the sample and may or may not correlate with viral culture results performed on the same sample.
11. This device is only used for testing direct human anterior nasal swab specimens. Viral transport media (VTM) should not be used with this test.

REFERENCES

1. Naming the coronavirus disease (COVID-19) and the virus that causes it. (n.d.). Retrieved from https://www.who.int/emergencies/diseases/novelcoronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it.
2. “Frequently Asked Questions – General Assembly of the United Nations.” United Nations, www.un.org/pga/75/coronavirus/faqs/.
3. World Health Organization. (2020). Advice on the use of masks in the community, during home care, and in health care settings in the context of COVID-19: interim guidance, 19 March 2020 (No. WHO/2019-nCoV/IPC_Masks/2020.2). World Health Organization.
4. Healthcare Professionals: Frequently Asked Questions and Answers. (2020, March 22). Retrieved from https://www.cdc.gov/coronavirus/2019ncov/hcp/faq.html.

TECHNICAL SUPPORT

For assistance regarding the ImmuView® COVID-19 Antigen Home Test, please call Technical Support at 833-919-0617 (Available Hours: Mon. to Fri.: 9 a.m. – 5 p.m. PST) or email at [email protected].
Test system problems may also be reported to the FDA using the MedWatch reporting system (phone: 1-800 FDA-1088; fax: 1-800 FDA-1078: or http://www.fda.gov/medwatch).

ORDERING AND CONTACT INFORMATION
CTK Biotech, Inc. | [email protected]
Call center 1-833-919-0617 | https://immuviewathome.com

INTERNATIONAL SYMBOL USAGE

13855 Stowe Drive,
Poway, CA 92064, USA
Tel: 858-457-8698
Fax: 858-535-1739
E-mail: [email protected]

References

• MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
• Frequently Asked Questions | General Assembly of the United Nations
• ImmuView
• ImmuView
• Coronavirus Disease 2019 (COVID-19) | CDC
• At-Home OTC COVID-19 Diagnostic Tests | FDA
• 800-222-1222" class="nturl" > Poison Control | Call Poison Help Centers Now 1-800-222-1222

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