Coronavirus Ag Antigen Rapid Test
COVID-19 Antigen Rapid Test
The Coronavirus Antigen Rapid Test, is an effective test to detect ongoing virus infection.
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 symptoms 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.
The LOD (Limit of Detection) of the Coronavirus Ag Rapid Test Cassette (Swab) is 1.15 x 102 TCID50/ml and there was no hook effect on with SARS-CoV-2 cultured virus (4.6 x 105 TCID50/mL).
Relative Sensitivity: 96.72% (95% CI*: 88.65%-99.60%)
Relative Specificity: 99.22% (95% CI*: 97.21%-99.91%)
Accuracy: 98.74% (95% CI*: 96.80%-99.66%)
*CI = Confidence Intervals
See attached Handbook for download.
The analysis must be carried out within a healthcare facility by personnel trained in sampling and interpreting the results. The assessment and quality assurance of SARS-CoV-2 antibody tests must be performed in consultation with clinical microbiological experience. The legal aspects to ensure patient safety must be considered, as well as the safety requirements for management systems, record keeping. Staff must be licensed, including doctors. The operations carried out must be reported to the inspection and control bodies for national health and healthcare.