Biopanda Reagents - Model RAPG-CVA-019 - COVID-19 Rapid Antigen Test
From COVID-19 Test Kit
The Biopanda COVID-19 Rapid Antigen (Ag) Test Kit is a qualitative lateral flow immunochromatographic assay for the detection of SARS-CoV-2 viral antigens in human nasopharyngeal or throat swab specimens. It is intended for use as a tool to assist in the diagnosis of SARS-CoV-2 infections. This test should not be used to rule out the possibility of infection on the basis of its results alone. This test kit is CE-marked for healthcare professional use only.
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Test Attributes
- Nasopharyngeal or throat swabs may be used for testing
- Results available in only 10-15 minutes
- All reagents and consumables included
- Easy to use
- Results can be read visually
- No need for an analyser
- Cost effective method for assisting in diagnosing COVID-19 infection.
Details
Sensitivity and Specificity
The COVID-19 Rapid Antigen Test has been evaluated using 571 nasopharyngeal and nasal swab samples and directly compared to RT-PCR.
Positive percent agreement (sensitivity): 94.1% (95%CI: 90.6% - 96.6%)
Negative percent agreement (specificity): 99.7% (95%CI*: 98.2% - 99.9%)
Storage Conditions
+ 2 - 30 °C, DO NOT FREEZE. Unopened test cassettes and buffer are stable for up to 24 months from date of manufacture.
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