«ALVETSENSE» reagent kit for the SARS-CoV‑2 qualitative detection
The ALVETSENSE reagent kit for the SARS-CoV‑2 qualitative detection by RT-PCR in real time (cat. No. AL-SARSV-96) is intended for the 2019-nCoV coronavirus RNA detection by a one-step polymerase chain reaction with fluorescence detection in real time (hereinafter RT-PCR-RT) in nucleic acid preparations isolated from smear samples from the external and internal surfaces of food packaging, containers and the product itself, hereinafter referred to as the kit. The kit detects the following genes: 3 loci of the orf1ab gene of the 2019-nCoV coronavirus and the S, E and N genes of the 2019-nCoV coronavirus.
The kit is used with the following recording amplifier models: CFX96, iQ5 (manufactured by Bio-Rad, Singapore / USA); DT-322, DTprime, DTlight (manufactured by NPO DNA-technology LLC (ООО «НПО ДНК-технология»), Russia); Rotor-Gene Q, Rotor-Gene 3000 (manufactured by Corbett Research, Australia), Rotor-Gene 6000 (manufactured by Qiagen, Germany).
The ALVETSENSE 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|
The ALVETSENSE kit 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.
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.
ALVETSENSE kit indication for use (cat. No. AL-SARSV-96)
Material testing to identify the COVID-19 causative agent in / on food products in the case of group cases of COVID-19 disease among workers in livestock farms, meat and dairy markets, food packaging enterprises. In this case, a study of the products of these enterprises (food samples) is carried out.
ALVETSENSE kit contraindication to the use (cat. No. AL-SARSV-96)
Package integrity violation, expired shelf life, failure to comply with the transportation conditions.
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.
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).