The VivaDiag™ SARS-CoV-2 RT-PCR Detection Kit for detecting SARS-CoV-2 is an in vitro diagnostic Real-Time reverse transcription-PCR assay for the qualitative detection of SARS-CoV-2 nucleic acids in throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) from individuals suspected of COVID-19 by their healthcare provider.

For professional use only
Not for at-home testing

Not Available for Sales in the US

SARS-CoV-2 RT-PCR Detection Kit

Ref Component Presentation 50rxns
1 SARS-CoV-2 Reaction Mix 1 tube, 950 μL
2 SARS-CoV-2 Enzyme Mix 1 tube, 50 μL
3 SARS-CoV-2 Negative Control 1 tube, 50 μL
4 SARS-CoV-2 Positive Control 1 tube, 50 μL

Product Features

  • Double-target detection of genes to improve diagnosis accuracy

    The ORF1ab gene of SARS-Cov-2 will be detected by FAM channel, and the N gene ofSARS-CoV-2 will be detected by ROX channel.

  • Negative and positive controls provide calibration for the kit

    Internal reference is used in the kit for quality control starting from sample collection.

  • Use anti-contamination system to prevent product contamination

    dUTP and UNG enzyme are used in the kit to prevent contamination of the amplifiedproducts.

  • With great clinical performance

    Clinical evaluation study was performed to evaluate the performance of the SARS-Cov-2RT-PCR Detection Kit. Compared with the comparator method, the PPA was 99.07%, andthe NPA was 98.97%.

Steps for Simple Test

Specification

Performance Sensitivity: 200 copies/mL
Test Principle RT-PCR
Sample Type Throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF)
Target Genes ORFlab, N
Test Time 70 min
Operation Temperature Room temperature
Storage Temperature -25℃ to -15℃
Shelf Life 12 months

Not Available for Sales in the US

**Warning**

NOTE: Test results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable respiratory 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. 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.