CLIA WAIVED RAPID TESTS
6320 Canoga Ave. Ste. 1500, FL 15
Woodland Hills, CA 91367
VIASURE SARS-CoV-2 (COVID-19), Flu & RSV Real Time PCR Detection Kit is designed for the identification of SARS-CoV-2, Influenza A/B (Flu A/B) and Human Respiratory Syncytial Virus A/B (RSV A/B) in respiratory samples.
The detection is done in one step real time RT format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well. The isolated RNA target is transcribed generating complementary DNA by reverse transcriptase which is followed by the amplification of two conserved regions of N gene (N1 and N2) for SARS-CoV-2, a conserved region of the M1 gene for Flu A/B and a conserved region of the N gene for RSV A/B using specifics primers and a fluorescent-labeled probe.
There is a detection limit of 20 genome copies/rxn for SARS-CoV-2, 5 genome copies/rxn for Flu A, 20 genome copies/rxn for Flu B and 10 genome copies/rxn for RSV.
The detection kit is based on the 5´ exonuclease activity of DNA polymerase. During DNA amplification, this enzyme cleaves the probe bounded to the complementary DNA sequence, separating the quencher dye from the reporter. This reaction generates an increase in the fluorescent signal which is proportional to the quantity of target template. This fluorescence can be measured on Real Time PCR platforms.
It contains a positive and a negative control that must be included in each run to correctly interpret the results. Also, the endogenous internal control (IC) in each well confirms the correct performance of the technique.
The product has been validated on nasopharyngeal and oropharyngeal specimens collected with synthetic fiber swabs with plastic and placed immediately into a sterile transport tube containing Universal transport medium (UTM) or Viral Transport Media (VTM).
Patient samples must be collected, transport and storage according to appropriate laboratory guidelines. For details, refer to the CDC guidelines (Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19)
The clinical performance was tested using 16 nucleic acids isolated from positive nasopharyngeal swabs collected in BD™ Universal Viral Transport System from patients with clinical suspicion of COVID-19 disease. 12 SARS-CoV-2 positive samples were found, and these results were in agreement with a RT-qPCR test developed according to the China CDC Primers and probes for detection 2019-nCoV. It was tested using 99 respiratory specimens (throat swabs) from symptomatic patients of viral respiratory infection.
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|CFR196TRUO||VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit||4 tubes x 24rxn|
|CFR112LRUO||VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit||12 x 8-well strips, low profile|
|CFR112HRUO||VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit||12 x 8-well strips, high profile|
|CFR113LRUO||VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit||96-well plate, low profile|
|CFR113HRUO||VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit||96-well plate, high profile|