Access Bio’s CareStart™ COVID-19 MDx RT-PCR
AN AMERICAN SOLUTION FOR RELIABLE
COVID-19 Testing
NOW FDA EMERGENCY USE AUTHORIZED
To effectively control the spread of the SARS-CoV-2, accurate detection of infectious cases is critical. The CareStart™ COVID-19 MDx RT-PCR is intended for qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens (such as and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage from individuals suspected of COVID-19 by their healthcare provider. At this time, testing is limited to CLIA-certified laboratories.
- Designed for use on those displaying symptoms of COVID-19
- Administered via nasopharyngeal, oropharyngeal and nasal swabs and nasopharyngeal wash/aspirate or nasal aspirate, and bronchoalveolar lavage.
- To detect all of SARS-CoV-2 mutations amplifies two unique target qenes of SARS-CoV-2
- Processing time is less than 83 minutes
- Clinically validated with high sensitivity and specificity
- Available for use with the following lab systems:
- CFX96™ system (Bio-Rad Laboratories, Inc.)
- Applied Biosystems 7500/7500 Fast Real-Time PCR System
(Thermofisher Scientific)
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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