CARESTART

COVID-19

MDx RT-PCR

COVID-19 DETECTION KITS

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.

PRODUCT SPECIFICATIONS

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

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

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.