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

PRODUCT BROCHURE

FACT SHEET FOR PATIENTS

FACT SHEET FOR HEALTHCARE PROVIDERS

IFU (INSTRUCTIONS FOR USE)

FDA EMERGENCY USE AUTHORIZATION

DISCLAIMER