COVID-19 MDX RT-PCR Test Kit for Laboratories
The KarmaCareTM COVID–19 MDx RT–PCR is a real–time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal, oropharyngeal and nasal swabs, and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage from individuals suspected of COVID-19 by their healthcare provider.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- For the qualitative detection of human coronavirus SARS–CoV–2 viral RNA extracted from respiratory tract specimens
- Processing time is less than 83 minutes
- For use under an Emergency Use Authorization (EUA) only
- For in vitro diagnostic use only
- For Prescription (Rx) Use only
CLINICAL PERFORMANCE
100% PPA and 100% NPA
(PPA: Positive Percent Agreement, NPA: Negative Percent Agreement)
Available for use with the following lab systems:
- CFX96 Touch™ system (Bio-Rad Laboratories, Inc.)
- Applied Biosystems 7500/7500 Fast Real-Time PCR System(Thermofisher Scientific)
PRODUCT DOCUMENTATION
FACT SHEET FOR HEALTHCARE PROVIDERS
IFU (INSTRUCTIONS FOR USE)
FDA EMERGENCY USE AUTHORIZATION
| CATALOG NO. | MCGM-100072 |
|---|---|
| PACKAGE UNIT | 100 Tests per kit |
| KIT COMPONENTS | 4x 1 Step RT-PCR Mix SARS-CoV-2 Primer/Probe Mix MS2 Phage Control External Positive Control External Negative Control |