Antigen Screen Test

Wholepower 2019-nCoV Antigen Screen Test

92.2% Sensitivity (95,8% at Ct < 32)
99.1% Specificity
Results in 15-20 minutes
Potential infected test materials sealed within test tube
Registered at Austrian Federal Office for Safety and Healthcare as in-vitro diagnostic devices for self-testing
Registered at The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM, No. AT185/21)
Registered at the FDA under Emergency Use Authorization (EUA)
CE marked

Clinical evaluation

A performance evaluation of the Wholepower 2019-nCoV Antigen Screen Test was conducted at 3 geographically diverse study sites.

697 clinical nasal swabs were collected from patients who were suspected of COVID-19 (within 7 days of onset). 154 were positive samples and 543 negative samples were tested. All samples were unaltered clinical specimens and confirmed with RT-PCR.

Each sample was blindly labelled by a nonparticipant. Separate sets of the blind coded were assigned. Samples were also randomized prior to testing.

As the table shows, the test has a sensitivity of 92.2% (95% CI: 86.8% to 95.5%) and a specificity of 99.1% (95% CI: 97.9% to 99.6%).

Product Information

The Wholepower 2019-nCoV Antigen Screen Test is a colloidal gold immunoassay for the qualitative determination of the 2019-nCoV nucleocapsid protein antigen in nasal swabs, using the double antibody sandwich method. Anti-2019-nCoV antibody (Test Line) and goat anti-mouse IgG antibody (Control Line) are used as the solid of the assay.

The anti-2019-nCoV antibody can bind with the 2019-nCoV nucleocapsid protein antigen in the specimen. During the test procedures, the 2019-nCoV nucleocapsid protein antigen in the specimen will bind with the colloidal gold-anti-2019-nCoV antibody specifically. Because of capillary and chromatographic effects of the Nitrocellulose membrane, the complexes migrate along the membrane to the anti-2019-nCoV antibody line (T), form Abα-Ag-Abβ-Au complexes and remain captured in the T line. As a result, a red colored band develops in T and the result is positive. If there is no 2019-nCoV nucleocapsid protein antigen in the specimen, there is no red band in the Test zone, indicating negative result. No matter if there’s 2019-nCoV antigen in the specimen, when the complexes migrate along the Control zone, a red band must be developed in the C zone.

Test Procedure

Specimen to be tested should be obtained and handled by standard methods for their collections.
Insert the entire absorbent tip of the swab into one nostril, but do not insert the swab more than 1.5 cm into the nose. Slowly rotate the swab in a circular path against the inside of the nostril at least 4 times for a total of 15 seconds. Be sure to collect any nasal drainage that may be present on the swab, gently remove the swab. Using the same swab, repeat the same collection procedure in the other nostril.
All specimens should be tested as soon as they are prepared. If necessary, they can be stored at 2-8 °C for up to 24 hours or at - 20 °C for longer periods. Restore the sample to room temperature before testing.

Reading the results

Negative:
Only one colored line appears in the control region (C).

Positive:
A colored line appears in the test region (T) and in the control region (C).

Invalid:
No visible line at all, or there is a visible line only in the test region (T) and not in the control region (C). Repeat with a new test kit.