PCR test coronavirus COVID-19

A set of reagents for the detection of RNA of coronavirus CoV by real-time polymerase chain reaction

The PCR-nCov reagent kit is intended for the qualitative determination (screening, monitoring) of 2019-nCoV coronavirus RNA in NK preparations isolated from samples obtained by taking a smear from the nose, nasopharynx and / or oropharynx, bronchial lavage obtained by fibrobronchoscopy ( bronchoalveolar lavage), (endo) tracheal, nasopharyngeal aspirate, sputum, biopsy or autopsy lung material, whole blood, serum, urine.

The diagnostic role of the reagent kit is the possibility of its use in supporting the diagnosis of specific pathology (severe acute respiratory infection - COVID-19) in the study of material from a patient (suspicious of a disease) and the indication of pathogenic biological agents (PBA).

The scope of the kit is clinical laboratory diagnostics, severe acute respiratory infection - COVID-19, specific indication of pathogenic biological agents. The kit can be used in medical and healthcare facilities.

Set Composition

The reagent kit consists of 5 reagents.

1. The reaction mixture in stripped microtubes, PC-nCov 6 strips of 8 microtubes

2. Thinner, RB 1 tube 0.8 ml

3. Positive control sample, FFP-nCov 1 tube

4. The solution for diluting PKO, OKO 1 test tube 1 ml

5. Internal positive control of isolation, VPK-V-RNA 1 tube 0.5 ml

Note: The ingredients that can influence the measurements are primers and fluorescent probes, the main characteristic of which for the end user is the annealing temperature Ta, which is 58 ° C. This characteristic is implemented using the temperature-time mode of amplification, therefore, its observance is strictly mandatory.

The reagent kit is designed for 48 determinations, including control samples.

ANALYTICAL CHARACTERISTICS

Sensitivity

Sensitivity - no more than 1.0x103 copies of RNA per milliliter of sample (copies · ml-1). To achieve this indicator, it is recommended that reagent kits be used to isolate NK that allow the selection of aliquots of the starting material (sample) with a volume of at least 100 μl.

Specificity

Specificity - false positive and false negative results in the analysis of samples of NK respiratory infections: viruses of severe acute respiratory syndrome (SARS-Cov), Middle East respiratory syndrome (MERS-Cov), influenza type H1N1, H5N1 and B, respiratory syncytial virus (RSV) adenoviruses, Coxiella burnetii, Streptococcus pneumoniae, Haemophilus influenzae type B, Legionella pneumophila, Metapneumovirus, Human respirovirus 1, Rhinovirus (14 obviously negative samples) were absent.

During the studies, 100% intramuscular, interstitial, and interserial reproducibility was observed for all positive samples.

Diagnostic sensitivity with a confidence level of 95% - 100%

Diagnostic specificity with a confidence level of 95% - 100%

Recommended Measuring Equipment

The PCR-RV device is registered in the Russian Federation as a medical device and has detection channels corresponding to FAM, R6G, ROX, Cy5 dyes (or their spectral analogues) - “ANK-32 (32M, 48)”, CFX-96 (BioRad, USA), Rotorgene, "DT Prime 4M1."

Set storage conditions

Storage of the kit - in a dry, dark place at a temperature of plus 2 to plus 8 ° C. The total shelf life at temperatures from plus 9 to plus 20 ° C should not exceed 14 days during the shelf life of the kit reagents.

Set transportation conditions

The transportation of the PCRnCov reagent kit should be carried out in accordance with TU 20.59.52-014-08534994-2020 by covered transport (road, rail or air) at temperatures from plus 2 to plus 8 ° C. Transportation up to 14 days is allowed at temperatures up to plus 20 ° С.

Set expiration date

The shelf life of a kit of reagents is 12 months from the date of issue.

Advantages of PCR test for coronavirus:

1) Compatible with most amplifiers

2) The cost of 1 study is 300 UAH

3) High sensitivity

4) Reagents are supplied in lyophilic form, which allows transporting and saving the kits without any special expenses.

5) The producton time for one reaction of 96 determinations is approximately 1 hour 30 minutes.

Country producer of the Russian Federation

The kit is delivered on order, prepaid within 14 days.