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)
Clinical Performance
- 100% PPAa and 100% NPAb
PRODUCT SPECIFICATIONS
One Step Real-Time Reverse Transcription PCR Test Method
Specifications and Technical Information
Package Unit
100 TESTS/KITSTechnology
Real-Time Transcription PCR
Reaction Time
83 MINUTES
Performance
Analyte
2019-Novel Coronavirus (SARS-CoV-2)
Specimen Type
UPPER RESPIRATORY SPECIMENS INCLUDING NASOPHARYNGEAL, OROPHARYNGEAL AND NASAL SWABS AND NASOPHARYNGEAL WASH / ASPIRATE OR NASAL ASPIRATE, AND BRONCHOALVEOLAR LAVAGE
Sample Volume
10 μL RNAStorage
Below -20°C
Shelf-Life
12 months
Internal Control
MS2 phage control
External Control
Positive control, negative control
Kit Component
4 X 1 STEP RT-PCR MIX, SARS-CoV-2 PRIMER/PROBE MIX, MS2-PHAGE CONTROLs POSITIVE CONTROL, NEGATIVE CONTROL IFU
ORDERING INFORMATION
Order Information
Cat. No.
MCGM-100072
PACKAGE UNIT
100 Tests / Kit
Kit Component
4 X 1 STEP RT-PCR MIX 2019-nCoV PRIMER/PROBE MS2-PHAGE CONTROL POSITIVE CONTROL NEGATIVE CONTROL IFUPRODUCT DOCUMENTATION
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