CareStart™ COVID-19 RT-PCR Test
The CareStart™ COVID-19 MDx RT-PCR is an industry-standard COVID-19 polymerase chain reaction (PCR) test intended for qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.
This PCR test kit limited to use in CLIA-certified laboratories has been independently tested with results objectively verified: in addition to a CE mark, this test manufactured by Access Bio has been authorized by the FDA under an Emergency Use Authorization (EUA). For nearly 20 years, Access Bio has been a global leader in engineering and manufacturing superior-quality diagnostic testing for infectious diseases.
Product Features
- Designed for use on those displaying symptoms of COVID-19
- Administered via upper respiratory specimens including oropharyngeal swabs, nasopharyngeal swabs/wash/aspirate or nasal aspirate, mid-turbinate swabs, and BALs
- Amplifies a total of two unique target genes of SARS-CoV-2
- Processing time is less than two hours
- Clinically validated with high sensitivity and specificity.
- Available for use with the following lab systems:
- CFX96TM Dx system (Bio-Rad Laboratories, Inc.)
- Applied Biosystems 7500 Real-Time PCR system (Thermofisher Scientific).
- Manufactured in the USA