SARS-CoV-2 Triplex PCR kit

REF 89-03 Form F

CE IVD

Product description

The SARS-CoV-2 Triplex PCR kit is one-step reverse transcription real-time PCR multiplex test for detection of SARS-CoV-2 nucleic acids from nasopharyngeal swabs, oropharyngeal swabs and saliva samples from individuals suspected of COVID-19.

SARS-CoV-2 Triplex PCR kit simultaneously detects three targets, in ORF1ab, ORF8, and N protein coding regions, each on separate detection channel. The detection of 3 regions increases the specificity of the test and makes it stable against potential mutations of the virus in the regions where primers or probes bind.

As internal control of quality of RNA extraction and reverse transcription reaction, the test uses specific set of primers and fluorescent probes for transcript of one of the human “housekeeping genes”.

Positive control reaction uses mix of in vitro transcribed RNAs corresponding to the target SARS-CoV-2 genome regions.

Technical specification

Assay Principle	one-step reactions of reverse transcription and real-time PCR with fluorescent probe detection.
Test results	qualitative
Sample material	nasopharyngeal swabs, oropharyngeal swabs and saliva samples in transport medium or NaCl solution
Analytical Sensitivity	10 copies per reaction
Diagnostic Sensitivity	100%
Diagnostic Specificity	100%
Kit size	100 tests
Kit content	PCR-Mix SC2 in a 2 mL tube, Taq DNA-polymerase with reverse transcriptase Positive control Negative control
Controls included in the kit	• endogenous internal control • positive control • negative control
Validated extraction methods	Magnetic DNA/RNA Extraction kit (Astra Biotech GmbH) Prime DNA/RNA Extraction kit (Astra Biotech GmbH)
Validated Thermocycler	Qiagen Rotor-Gene Q Corbett Research Rotor-Gene 3000/6000 Bio-Rad CFX96/CFX96 Touch Roche Light Cycler 96 DNA-Technology DTprime/DTlite Sacace SaCycler Thermo Fisher Scientific/Applied Biosystems - QuantStudio-5
Detection channels required for the PCR cycler:	ROX, HEX, Cy5, FAM
Storage	-18...-30 °C, Storage at ≤+25 °C is allowed for no more than 5 days
Approval	for in-vitro Diagnostics

Confirmed detection capability for the following virus variants:

VOC Alpha 202012/01 GRY (B.1.1.7), VOC Beta GH/501Y.V2 (B.1.351), VOC Gamma GR/501Y.V3 (P.1), VOC Delta G/478K.V1 (B.1.617.2), VOI Eta GR/484K.V3 (B.1.525), B.1.1.523, АТ.1, VOC Alpha 202012/01 GRY (AY.4). VOI Epsilon GH/452R.V1 (B.1.429+B.1.427/CAL.20C), VOI Zeta GR/484K.V2 (P.2), VOI Theta GR/1092K.V1 (P.3), VOI Iota GH/253G.V1 (B.1.526), VOI Kappa G/452R.V3 (B.1.617.1), VOI Lambda GR/452Q.V1 (C.37), VOI Mu GH (B.1.621+B.1.621.1), VUM GH/490R (B.1.640). VOC Omicron GR/484A (B.1.1.529+BA.1+BA.2+BA.3+BA.4+BA.5).

Features:

Advanced test design
• three SARS-CoV-2 specific targets chosen from least variable regions in ORF1ab, ORF8, and N genes
• multiplicity of targets increases the robustness of the test in case of possible arising mutations in the regions where primers or probes bind

Control of the entire diagnostic process
• endogenous internal control (transcript of one of human «housekeeping genes») allows to monitor the quality of sampling, RNA extraction procedure, reverse transcription and PCR amplification, as well as detection reactions
• positive control (in vitro transcribed RNA of target regions) allows to monitor the quality of reverse transcription and PCR amplification and detection reactions
• negative control allows to monitor the cases of possible contamination

Single tube design
• simultaneous detection of three targets + internal control in one tube
• internal control is included in master mix - no additional pipetting required

Related products:

Magnetic DNA/RNA Extraction kit
Prime DNA/RNA Extraction kit

Downloads:

Product flyer