SARS-CoV-2 Rapid Antigen Test

The (Roche) SARS-CoV-2 Rapid Antigen Test, available at Nine Elms Clinic, is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environment.

The SARS-CoV-2 Rapid Antibody Test is a lateral flow rapid chromatographic immunoassay intended for qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environment.

Features and benefits of the SARS-CoV-2 Rapid Antigen Test

Besides laboratory PCR testing, antigen assays can also be offered as rapid testing in near-patient settings. The SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of specific antigens of SARS‑CoV‑2 present in nasopharyngeal or combined nasopharyngeal/oropharyngeal samples. This test is intended to detect antigen from the SARS‑CoV‑2 virus in individuals suspected of COVID‑19. This product is strictly intended for professional use in laboratory and Point of Care environments. Similar to laboratory instruments, it detects a SARS-CoV-2 antigen, the nucleoprotein. It can therefore be used to assess whether a person is infected with SARS-CoV-2 by providing a qualitative result showing coloured bands indicating the presence of SARS-CoV-2 antigens.

The SARS-CoV-2 Rapid Antigen Test enables fast decision making e.g. whether patients need to be put in quarantine, reducing the risk of further spreading. In addition to that it allows for screening of individuals after confirmed exposure to a SARS-CoV-2 infected person or individuals at risk of exposure such as healthcare workers.

The SARS-CoV-2 Rapid Antigen Test allows for decentralized testing at the point of care and helps to expand the range and quantity of direct virus testing into otherwise inaccessible locations. Rapid point of care testing can sometimes be the only viable option if lab testing is not sufficiently available. In addition to that, the SARS-CoV-2 Rapid Antigen Test is an instrument free test, allowing testing in rural/ low-infrastructure areas.

The benefits of the SARS-CoV-2 Rapid Antigen Test in short:
• Getting a quick result within 15-30 minutes – no need for a follow-up appointment to discuss the result
• Easy handling which does not require specific training
• No instrument required
• Allowing decentralized testing or access to testing in areas where laboratory testing is not available

Reference: www.roche.com

How does the Antigen test work?

1. Collecting a sample

Insert a sterile swab into the nostril of the patient and then rotate the swab 3-4 times against the nasopharyngeal surface. Withdraw the swab from the nasal cavity.

2. Preparing a sample

Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Press the nozzle cap tightly onto the tube.

3. Performing a test

Place the test device on a flat surface and apply 3 drops of extracted sample in a 90° angle to the specimen well of the test device.

4. Read and Interpreting results

Read the test result at 15 to 30 min. A coloured line appears in the top section of the result window to show that the test is working properly, if no control line is visible the test is invalid. In case of a positive result, a colored line appears in the lower section of the result window.

SARS-CoV-2 Rapid Antigen Test characteristics

Assay format - Lateral flow test / immunochromatographic
Instrument - No
Testing time - 15-30 minutes
Specificity - 99.2%
Sensitivity - 96.52% (Ct value ≤ 30)
Antigen - N
Sample material - Nasopharyngeal Swab
Reagents - mAb anti-COVID19 antibody, mAb anti-Chicken IgY, mAb anti-COVID-19 antibody‑gold conjugate, Purified chicken IgY‑gold conjugate

Reference: www.roche.com

SARS-CoV-2 / Covid-19 tests available at Nine Elms Clinic