COVID-19 (Coronavirus) PCR Test Kit
- 3 target-system minimizes potential for reduced detection of new SARS-CoV-3 variants
- Multiplex format allows for single-well detection of 3 different targets
- Compatible with multiple PCR instruments after proper validation
- Manufactured in the USA. Approved by FDA under Emergency Use Authorization
Smart Detect™ SARS-CoV-2 rRT-PCR Kit
The test is a real-time reverse transcription polymerase chain reac-tion (rRT-PCR) assay designed to qualitatively detect RNA from SARS-CoV-2 in respiratory specimens from individuals with signs and symptoms of infection who are suspected of COVID-19 by their healthcare provider.
Performance
- Sensitivity: 100% PPA
- Specificity: 96.7% NPA
Specifications
- Gene Targets: E, N, ORF1b
- Contents: Primer Probe Mix and Kit Controls
- Specimen: Nasopharyngeal or nasal swabs
Limit of Detection
| 7500 Fast Dx Real-Time PCR Instrument | CFX96 Touch Real-Time PCR | |
|---|---|---|
| Per reaction | 12.5 GE | 10 GE |
| Per ml specimen | 1100 GE | 860 GE |
Other
- Format: rRT-PCR
- Time to Result: ~4 hours
- Storage: -20℃ or below
- Shelf Life: 12 months
InBios Smart Detect™ SARS-CoV-2 rRT-PCR Kit
Test:
COVID-19 PCR Test
Specimen:
Nasopharyngeal or nasal swabs
Packaging:
45 tests/box
$1,125 ($25/test kit) | PURCHASEPrecautions
- For professional in vitro diagnostic use only. Do not use after expiration date;
- Do not eat, drink or smoke in the area where the specimens or kits are handled;
- Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens;
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested;
- Humidity and temperature can adversely affect results.
Emergency Use Authorization (EUA)
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA) . The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of the virus that causes COVID-19.
The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
If you have any queries regarding the product, please contact us.
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General
Support
Phone: 1.855.722.4672
Address :2550 Sandy Plains Rd, Suite 225-356, Marietta, GA 30066
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