Loading

Wholepower One Step 2019-Novel Coronavirus (2019-nCoV) Rapid Antigen Test

Wholepower One Step 2019-Novel Coronavirus (2019-nCoV) Rapid Antigen Test

  • 96.4% Sensitivity
  • 99.2% Specificity
  • CE Certified and listed at The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)
  • Results in <15 minutes

 

Clinical evaluation

For the evaluation of the diagnostic performance of the Wholepower One Step 2019-Novel Coronavirus (2019-nCoV) Rapid Antigen Test, RT-PCR Covid-19 positive samples from 110 individuals and RT-PCR Covid-19 negative samples from 390 individuals were evaluated in this study.

As the table shows, the test has a sensitivity of 96.4% (95% CI: 91.0% to 98.6%) and a specificity of 99.2% (95% CI: 97.8% to 99.7%).

Product Information

The Wholepower One Step 2019-Novel Coronavirus (2019-nCoV) Rapid Antigen Test Cassette is a colloidal gold immunoassay for the qualitative determination of SARS-CoV-2-Antigens in nasopharyngeal swab.

Anti-SARS-CoV-2 antibody (the Test Line (T) on the test cassette) and goat anti-mouse IgG antibody (the Control Line (C) on the test cassette) are used as the solid of the assay. The anti-SARS-CoV-2 antibody can bind with the SARSCoV-2 antigen in the nasopharyngeal and swab. The assay tests the SARS-CoV-2 antigen qualitatively in nasopharyngeal swab specimen, using the double antibody sandwich method. During the test procedures, the SARS-CoV-2 antigen in the nasopharyngeal swab specimen will bind with the colloidal gold-anti-SARS-CoV-2 antibody specifically. Because of capillary and chromato-graphic effects of the Nitrocellulose membrane, the complexes migrate along the membrane to the anti-SARS-CoV-2 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 SARS-CoV-2 antigen in the nasopharyngeal, there is no red band in the Test zone, indicating negative result. No matter if there’s SARS-CoV-2 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 collection and preparation

 

  1. Specimen to be tested should be obtained and handled by standard methods for their collections. Nasopharyngeal swab specimen: Carefully insert a sterile swab into the nostril of the patient. Using gentle rotation, push the swab til resistance is met and the tip of the swab is reaching the surface of the posterior nasopharynx. Rotate the swab several times against the nasopharyn-geal wall. Remove the swab from the nostril carefully.
  2. All specimens should be tested as soon as early they are prepared. If necessary, they may 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.
Sample Preparation
  1. Remove a test device from the foil pouch by tearing at the notch and place it on a level surface.
  2. Hold the bottle with the extraction reagent vertically and add 12-15 drops (400μL) into the Extraction tube.
  3. Insert the swab with the sample into the extraction solution and mix by turning the swab 10 times.
  4. Remove the swab while squeezing the tube to extract most of the specimen from the swab.
  5. Place the nozzle cap and apply 3 drops (60~70μl) into the sample well of the test device.
  6. Read the result within 15 minutes. Do not read results after more than 30 minutes.
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.

Antibody Test

Find more information about the Wholepower Antibody Test.