Thermo Scientific CoviPath COVID-19 RT-PCR Kit, ICMR Approved

Product Details :

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 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.

Additional Information:

Packaging Details:

1)Catalog number-A50780 Unit -200 reactions

2)Catalog number-A52000 Unit -500 reactions