Applied Biosystems™ CoviPath™ COVID-19 RT-PCR Kit

The CoviPath COVID-19 RT-PCR Kit is a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in 200 or 500 samples including controls. The kit includes the following:

• CoviPath COVID-19 Assay Multiplex—a multiplexed assay that contains two primer/probe sets specific to different SARS-CoV-2 genomic regions (ORF1ab and N gene) and one primer/probe set targeting the RNase P gene. The RNase P gene serves as an internal positive control to monitor the sample source.
• CoviPath COVID-19 Control—an RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assay
• CoviPath 1-Step Multiplex Master Mix (No ROX)

For In Vitro Diagnostic Use – Approved by Indian Council for Medical Research (ICMR)
The CoviPath COVID-19 RT-PCR Kit has been approved for in vitro diagnostic use by the Indian Council for Medical Research (ICMR) and Drug Control General of India (DCGI).

• This test has been authorized by the ICMR – DCGI under MDR 2017 rules for use by authorized laboratories.
• This test has been authorized only for the multiplex real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS CoV 2, not for any other viruses or pathogens.

Intended use
The CoviPath COVID-19 RT-PCR Kit contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19.

The CoviPath COVID-19 RT-PCR Kit is intended to be used as part of a customer defined and validated workflow that generates a reportable result for detection of SARS-CoV-2. The customer’s workflow will need to include a sample preparation method, a choice of a real time PCR instrument and analysis software, as well as the CoviPath COVID-19 RT-PCR Kit.

The CoviPath COVID-19 RT-PCR Kit is for in vitro diagnostic use only. Testing with the kit can be done with Applied Biosystems real-time PCR instruments with FAM dye, VIC dye, and JUN dye or any RT-PCR platform with 3 dye channels in molecular biology laboratories certified to perform high complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The laboratories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Testing with the CoviPath COVID-19 Combo Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

For In Vitro Diagnostic Use only.