CareStart -Model MDx RT-PCR -COVID-19 Detection Kits

SHARE

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.

Most popular related searches

COVID-19 detection

qualitative detection of SARS-CoV-2

real-time PCR system

nasal aspirators

nasal aspirator

Package Unit: 100 Tests/Kits
Technology: Real-Time Transcription PCR
Reaction Time: 83 Minutes
Performance: Analytical sensitivity
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:10µl 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

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% PPA^a and 100% NPA^b

^aPPA: Positive Percent Agreement, ^bNPA: Negative Percent Agreement.