HIBERNIA MEDICAL FlowFlex COVID-19 Rapid Test Kits Instruction Manual

HIBERNIA MEDICAL FlowFlex SARS-CoV-2 Antigen Rapid Test (Self-Testing)

Package Insert Instruction Manual

A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens.
For in vitro diagnostic use only. For self-testing.

Carefully read the instructions before performing the test.

PREPARATION

TEST PROCEDURE

SPECIMEN COLLECTION

RESULT INTERPRETATION

SAFELY DISPOSE OF YOUR TEST KIT

Once your test is complete, put all of the used test kit contents in the waste bag provided. Put in your general household waste.

INTENDED USE

The SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms.

The test can also test specimens from individuals without symptoms. It does not differentiate between SARS-CoV and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 antigen. This antigen is generally found in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but individual 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 exact cause of disease.

Negative results from individuals with symptoms beyond seven days should be treated as likely negative. Confirm with a molecular assay, if necessary. Negative results do not rule out SARS-CoV-2 infection. SARS-CoV-2 Antigen Rapid Test is intended to be used to help the diagnosis of SARS-CoV-2 infection.

The usability of self-testing by an individual aged under 18 years has not been determined.

It is suggested that individual under 18 years of age should be tested by an adult.

SUMMARY

The new coronaviruses belong to the beta genus. COVID-19 is an acute respiratory infectious disease. Currently, patients infected by the new coronavirus are the main source of infection; infected people without symptoms can also infect others. Based on the current knowledge, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main symptoms include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are found in a few cases.

PRINCIPLE

The SARS-CoV-2 Antigen Rapid Test is a test for the detection of the nucleocapsid antigen from SARS-CoV-2 in human anterior nasal swab specimens. Test results are read visually at 15-30 minutes based on the presence or absence of colored lines.

To serve as a procedural control, a colored line will always appear in the control line region indicating that sufficient specimen volume was added and membrane absorption has occurred.

REAGENTS

The test cassette contains anti-SARS-CoV-2 antibodies and goat anti mouse IgG. The extraction buffer tube contains detergent and tris buffer.

PRECAUTIONS

• Read the SARS-CoV-2 Antigen Rapid Test Package Insert carefully before performing a test. Failure to follow directions may produce inaccurate test results.
• Do not use the test after the expiration date shown on the pouch.
• Do not eat, drink, or smoke before and during the test.
• Do not use the test if the pouch is damaged.
• All used tests, specimens and potentially contaminated materials should be discarded according to local regulations.
• Humidity and temperature can adversely affect results.
• The test line for a high viral load sample may become visible within 15 minutes, or as soon as the sample passes the test line region.
• The test line for a low viral load sample may become visible within 30 minutes.
• Do not collect the nasal swab specimen when nosebleed happens.
• Wash hands thoroughly after use.
• If the extraction buffer contacts the skin or eyes accidentally, flush with large amounts of water and seek medical attention if necessary.

STORAGE AND STABILITY

• The kit can be stored at temperatures between 2 – 30 °C.
• The test is stable until the expiration date printed on the sealed pouch. Do not use after the expiration date.
• The test must remain in the sealed pouch until use.
• DO NOT FREEZE.

QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the control line region (C) is an internal procedural control. It confirms that enough specimen volume was added, and the correct procedure was carried out.

LIMITATIONS

1. The SARS-CoV-2 Antigen Rapid Test is for self-testing use only. The test should only be used for the detection of SARS-CoV-2 antigens in nasal swab specimens. The intensity of the test line does not necessarily relate to the SARS-CoV-2 viral load in the specimen.
2. A false-negative test may result if the level of antigen in a sample is below the detection limit of the test or if the sample was collected incorrectly.
3. Test results should be looked at with other clinical data available to the doctor.
4. A positive test result does not rule out co-infections with other pathogens.
5. A positive test result does not differentiate between SARS-CoV and SARS-CoV-2.
6. A negative test result does not rule out other viral or bacterial infections.
7. A negative result, from an individual having symptoms beyond seven days, should be treated as likely negative and confirmed with a molecular assay, if necessary.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

Performance of the SARS-CoV-2 Antigen Rapid Test was established with 605 nasal swabs collected from symptomatic individuals who were suspected of COVID-19. The results show that the relative sensitivity and the relative specificity are as follows:

Clinical Performance for SARS-CoV-2 Antigen Rapid Test

Relative Sensitivity: 97.1% (93.1%-98.9%)
Accuracy: 98.8% (97.6%-99.5%)

Relative Specificity: 99.5% (98.2%-99.9%)
95% Confidence Intervals

Stratification of the positive samples post onset of symptoms between 0-3 days has a positive percent agreement (PPA) of 98.8% (n=81) and 4-7 days has a PPA of 96.8% (n=62).

Positive samples with Ct value ≤33 have a higher positive percent agreement (PPA) of 98.7% (n=153).

Limit of Detection (LOD)

The LOD of SARS-CoV-2 Antigen Rapid Test was established using limiting dilutions of an inactivated viral sample. The viral sample was spiked with negative human nasal sample pool into a series of concentrations. Each level was tested for 30 replicates. The results show that the LOD is 1.6*102 TCID50/mL.

Cross-Reactivity (Analytical Specificity) and Microbial Interference

Cross-reactivity was evaluated by testing a panel of related pathogens and microorganisms that are likely to be present in the nasal cavity. Each organism and virus were tested in the absence or presence of heat-inactivated SARS-CoV-2 virus at low positive level.

No cross-reactivity or interference was observed with the following microorganisms:

The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.

USABILITY STUDY

A Usability Study indicated similar device performances comparing lay people to healthcare professionals (HCPs) from a pool of 425 samples. Positive percent agreement is 92.1% and negative percent agreement is 98.9%. Overall agreement is 96.2%.

The lay person questionnaire together with the observation recorded by a HCP showed that the package insert can be easily followed by a lay person, and that the test can be easily operated by a lay person.

BIBLIOGRAPHY

1. Shuo Su, Gary Wong, Weifeng Shi, et al. Epidemiology, Genetic recombination, and pathogenesis of coronaviruses. Trends in Microbiology, June 2016, vol. 24, No. 6: 490-502
2. Susan R. Weiss, Julian L. Leibowitz, Coronavirus Pathogenesis, Advances in Virus Research, Volume 81: 85-164

Index of Symbols

Index of Contents

Number: 1151327403
Effective Date: 2021-06-29

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