CareStart™

COVID-19

MDx RT-PCR

COVID-19 DETECTION KITS

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
aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.
PRODUCT SPECIFICATIOINS
ONE STEP REAL-TIME REVERSE TRANSCRIPTION PCR TEST METHOD

SPECIFICATIONS AND TECHNICAL INFORMATION

PACKAGE UNIT
100 TESTS/KITS
TECHNOLOGY
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 RNA
STORAGE
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
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