CareStart COVID-19 MDx RT-PCR

Slide

CARESTART™

COVID-19
MDx RT-PCR


COVID-19 DETECTION KITS


ORDERING INFO

Slide

CARESTART

COVID-19
MDx RT-PCR


COVID-19 DETECTION KITS


ORDERING INFO
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
aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.
  • 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

Test Method

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