Access Bio’s CareStart™ COVID-19 MDx RT-PCR

AN AMERICAN SOLUTION FOR
RELIABLE COVID-19 TESTING

NOW FDA EMERGENCY USE AUTHORIZED

The CareStart™ 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 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 use under an Emergency Use Authorization (EUA) only
○ For in vitro diagnostic use only
○ Rx Use only
○ For the qualitative detection of human coronavirus SARS-CoV-2 viral
RNA extracted from respiratory tract specimens
○ Administered via nasopharyngeal, oropharyngeal and nasal swabs and nasopharyngeal wash/aspirate or nasal aspirate, and bronchoalveolar lavage
○ Processing time is less than 83 minutes

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)

TEST METHOD

ONE STEP REAL-TIME REVERSE TRANSCRIPTION PCR

The reverse transcription (RT) and qPCR step are both conducted in the same reaction well. As the specific sequence is amplified the taqman probe hybridized to the target is dissociated to generate fluorescence.