ACCESS BIO

CareStart™ COVID-19 MDx RT-PCR Test

Reliable, flexible, and sensitive molecular test to meet testing needs

The Access Bio, Inc. CareStart™ COVID-19 MDx RT-PCR test uses real-time reverse transcription-polymerase chain reaction (RT-PCR) to detect RNA of the COVID-19 nucleocapsid gene (N gene) and RNA-dependent RNA polymerase gene (RdRp gene) in test subjects, resulting in faster detection (83 minutes).

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.

CareStart PCR test
  • 100% PPA and NPA per FDA Testing Results
  • Detects two target regions simultaneously, N and RdRP gene of SARS-2 CoV
  • Manufactured entirely in the U.S. by a U.S. headquartered company

The CareStart™ COVID-19 MDx RT-PCR has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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