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
ORDER 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 IFU |
PRODUCT DOCUMENTATION
TEST METHOD
