«ALVETSENSE» Real-Time PCR kit

The method of procedure (cat. No. AL-SARSV-96) is based on the one-step RT-PCR method with real-time detection. The detection of target RNA, as well as control samples of RT-PCR and internal control, is carried out due to the release of fluorophore molecules FAM, ROX and HEX as a result of cleavage of specific probes by polymerase in the amplification process of cDNA strands synthesized from the 2019-nCoV RNA matrix. Registration of the increase or absence of a specific fluorescent signal is performed in each reaction mixture simultaneously using three fluorescence detection channels FAM, ROX and HEX. The kit method of procedure is based on the combination of reverse transcription and amplification in a one-step process carried out in each tube. All the necessary reagents for reverse transcription to obtain the target cDNA and polymerase chain reaction are included in the kit components.

«AL­VET­SENSE» Real-Time PCR kit (cat. No. AL-SAR­SV-96) is de­signed for 96 samples, in­clud­ing con­trol samples and is ap­plic­able for manu­al PCR re­ac­tions.

• ALVETSENSE reaction buffer – 1,5 mL × 1 tube;
• ALVETSENSE RT polymerase – 0,12 mL × 1 tube;
• PSC – 0,1 mL × 1 tube;
• NSC – 0,5 mL × 1 tube.

Areas of use

In laboratory diagnostics and in research practice for the 2019-nCoV RNA qualitative determination smear samples from the external and internal surfaces of food packaging, containers and the products themselves, in specialized laboratories for sanitary examination and the food industry. For in vitro studies only.

Assay functional use

2019-nCoV detection in / on food products, ensuring epidemiological safety, identifying possible 2019-nCoV transmission sources and routes.

Analytical sensitivity

Diagnostic sensitivity SARS-CoV-2 human coronavirus RNA detection, not less than 100 copies / ml in the original material, which corresponds to 5 genomic equivalents in the PCR reaction. Product sensitivity is also determined using EDX SARS-CoV-2 Positive Run Control reference material manufactured by Bio-Rad Laboratories. These controls include RNA transcripts of the ORF1ab, RdRP, N, E, S genes of the SARS-CoV-2 coronavirus and allow to evaluate the test system performance from the collection and isolation of a nucleic acid preparation from the sample to the real-time RT-PCR.

Analytical specificity.

There were no nonspecific reactions when testing human RNA / DNA samples and a panel of RNA / DNA samples of the following microorganisms: Chlamydia pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Treponema pallidum, Toxoplasma gondii, HSV types 1 and 2, CMV, HCV, HHV6, HIV1 , 2, HPV (types 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59), respiratory syncytial virus (hRSv), metapneumovirus (hMpv), parainfluenza viruses types 1, 2 , 3 and 4 (hPiv1-4), human coronaviruses (except 2019-nCoV coronavirus), rhinoviruses (hRv), DNA of adenoviruses of B, C and E groups (hAdv), bocavirus (hBov).