DIAGNOVITAL PCR Test Kit FDA EUA APPROVED

Diagnovital SARS-CoV-2 Real-Time PCR Kit is a Real-Time Qualitative RT-PCR-based test used for the detection of SARS-CoV-2 intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swabs and BAL specimens from individuals suspected of COVID-19 by their healthcare provider. The test is based on conventional RT-PCR technology including extraction and purification of the nucleic acid genome of SARS-CoV-2 followed by PCR amplification and detection.

Fact Sheets Available for Patients and Healthcare Providers Upon Request:

  • IFU
  • Test Data
  • Where this is being used
  • FACT SHEET FOR PATIENTS
  • FACT SHEET FOR HEALTHCARE PROVIDERS
  • FDA EUA APPROVAL

 

Production availability changes on a regular basis.

Please contact info@medihealthsupply.com for a quote.

Category:
Description

Diagnovital SARS-CoV-2 Real-Time PCR Kit is a Real-Time Qualitative RT-PCR-based test used for the detection of SARS-CoV-2 intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swabs and BAL specimens from individuals suspected of COVID-19 by their healthcare provider. The test is based on conventional RT-PCR technology including extraction and purification of the nucleic acid genome of SARS-CoV-2 followed by PCR amplification and detection.

Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers and probes specific to the SARS-CoV-2 envelope gene (E-gene) and the polymerase gene (RdRP). The RdRP gene target is detected by one probe, unique to SARS-CoV-2. Additionally, a conserved region in the structural protein envelope E-gene was chosen also for the pan-Sarbecovirus detection. The pan-Sarbecovirus detection sets will also detect SARS-CoV-2 virus.

Selective amplification of Internal Control is achieved by the use of non-competitive, sequence specific forward and reverse primers and a probe for the endogeneous human RNAseP gene which have no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for amplification.

Diagnovital SARS-CoV-2 Real-Time PCR Kit has been validated for use with RTA Viral Nucleic Acid Isolation Kit or RTA Viral RNA Isolation Kit for its best performance.

Diagnovital Real Time PCR Kits are certified and marked with CE-IVD to meet specific quality and purity requirements of in-vitro diagnostic use.

The kit follows CDC’s and WHO’s latest detection guidelines (04/2020).

PLEASE NOTE:

This product is shipped in dry ice and cold chain logistic. Please allow for a delivery time of 5-10 days.

Fact Sheets Available for Patients and Healthcare Providers Upon Request:

  • IFU
  • Test Data
  • Where this is being used
  • FACT SHEET FOR PATIENTS
  • FACT SHEET FOR HEALTHCARE PROVIDERS
  • FDA EUA APPROVAL

 

 

Production availability changes on a regular basis.

Please contact info@medihealthsupply.com for a quote.