RAPID TEST COVID-19 Ag 20T ORIENT GENE
Rapid Test to limit the spread of SARS-CoV-2 and COVID – 19
Extreme sensitivity & specialty …
Nasal or Nasopharyngeal swab
The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first ten days of symptom onset. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. Negative results from
patients with symptom onset beyond ten days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. The Coronavirus Ag Rapid Test Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
- 20 Test Cassettes
- Extraction Buffer Vials
- 20 Sterile Swabs
- 20 Extraction Tubes and Tips
- 1 Workstation
- 1 Package Insert
The Coronavirus Ag Rapid Test Cassette (Swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in direct nasopharyngeal (NP) swab. The test strip is composed of the following
parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates dried in the reagent pad
are dissolved and migrate along with the sample. If SARS-CoV-2 nucleocapsid antigen is present in the sample, a complex forms between the anti-SARS-2 conjugate and the virus will be captured by the specific anti-SARS-2 monoclonal antibodies coated on the test line region (T). Absence of the test line (T) suggests a negative result. To serve as a
procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.
Clinical Performance of the Coronavirus Ag Rapid Test (Swab) was evaluated by being involved in 7 non-laboratory sites within the US, where patients were enrolled and tested. Testing was performed by 24 non laboratorian Health Care Workers that were not familiar with the testing procedure. A total of 317 fresh nasopharyngeal swab samples was collected and tested, which includes 61 positive samples and 256 negative samples. The Coronavirus Ag Rapid Test (Swab) results were compared to results of Emergency Use Authorized RT-PCR assays for SARS-CoV-2 from nasopharyngeal swab specimen.
Test sensitivity: 98.32% (95%CI*: 94.06%-99.80%)
Test specificity: 99.60% (95%CI*: 98.83%-99.92%)
Relative accuracy: 99.42% (95%CI*: 98.66%-99.81%)
Available in a package of 20 tests.