Kits of reagents for molecular genetic

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Kits for determination of hereditary cancer predisposition

TestGene is one of the market leaders in oncological test systems. The kits have a high level of sensitivity and specificity and are used by specialists from leading cancer centers in Russia.

HRR SCREENING
Registration certificate RC No. RZN 2022/16592 dated 24.02.2022
The kit is used in screening for predisposition to breast, ovarian, prostate, pancreatic and stomach cancer. The assay detects 16 germinal mutations in the HRR genes. 8 additional mutations which are the most relevant for the Eurasian region are detected apart from 8 common ones.*

BRCA1 c.5266dupC, c.181T>G, c.5251C>T, c.4035delA, c.5161C>T, c.4675G>A, c.68_69del, c.3700_3704del, c.1961delA
BRCA2 c.3749dupA, c.961_962insAA
CHEK2 c.470T>C, c.1100delC, c.444+1G>A, c.893_897del
PALB2 c.1592delT

Detection method: real-time PCR (melting curves)
Material: peripheral blood, buccal scraping
Number of reactions: 48

Analytical sensitivity: 10 copies of the BRCA1, BRCA2, CHEK2, PALB2 genes in 1 µl of DNA solution
Sensitivity 100%
Specificity 100%

* information on the frequency of hereditary mutations in the genes of the DNA repair system (homologous recombination repair, HRR) is contained in the oncoBRCA database obtained as part of the Hereditary Syndromes in the Russian Federation project, https://oncobrca.ru/


QUASAR-BRCA1/2
Registration certificate RC No. RZN 2022/18317 dated 23.09.2022
The kit is designed for detection of germline and somatic mutations in the BRCA1, BRCA2 genes and is recommended for screening for hereditary forms of breast cancer, ovarian cancer in potentially healthy women and for examining patients diagnosed with breast and ovarian cancer in order to determine an effective treat- ment strategy and predict the effectiveness of the treatment.

The assay is used to detect all mutations in the coding regions of the BRCA1 and BRCA2 genes, as well as in the adjacent intron regions.

Detection method: real-time PCR + massive parallel sequencing (NGS)
Material: whole blood/ formalin-fixed and paraffin-embedded tissue (FFPE blocks)
Number of tests: 48/96

Analytical sensitivity: 300 copies of the BRCA1, BRCA2 genes in 1 µl of DNA solution
Sensitivity: whole blood 94.22-100% / tissue 90.75-100%
Specificity: whole blood 91.78-100% / tissue 88.06-100%

Kits for determination of medical treatment strategy for oncological diseases

TestGene is one of the market leaders in oncological test systems. The kits have a high level of sensitivity and specificity and are used by specialists from leading cancer centers in Russia.

The test systems are designed for detection of 16 mutations in the BRCA1, BRCA2 genes - 8 additional mutations which are the most relevant for the Eurasian region are detected in addition to 8 common ones.*

BRCA1 c.5266dupC, c.181T>G, c.5251C>T, c.5161C>T, c.4035delA, c.1961delA, c.4675G>A, c.68_69del, c.3700_3704del, c.4689C>G, c.3756_3759del
BRCA2 c.3749dupA, c.961_962insAA, c.2897_2898del, c.8754+1G, 6174delT

* information on the frequency of hereditary mutations in the genes of the DNA repair system (homologous recombination repair, HRR) is contained in the oncoBRCA database obtained as part of the Hereditary Syndromes in the Russian Federation project, https://oncobrca.ru/


BRCA1,2-DIAGNOSTICS
Registration certificate RC No. RZN 2022/16570 dated 22.02.2022
Registration certificate CE Certificate
The kit is designed for detection of 16 germline mutations in the BRCA1 and BRCA2 genes and is used in diagnostics of hereditary forms of breast, ovarian, pancreatic and stomach cancer to determine an effective treatment strategy.

Detection method: real-time PCR (melting curves)
Material: peripheral blood, buccal scraping
Number of reactions: 48

Analytical sensitivity: 10 copies of the BRCA1, BRCA2 genes in 1 µl of DNA solution
Sensitivity 100 % (with a confidence level of 95 %) 
Specificity 100 % (with a confidence level of 95 %)


BRCA1,2-TISSUE
Registration certificate No. RZN 2022/17324 dated 24.05.2022
The The kit is designed for detection of 16 somatic mutations in the BRCA1, BRCA2 genes and is used in the examination of patients with hereditary forms of breast, ovarian, pancreatic and stomach cancer. The assay allows for prediction of the course of the disease and determination of an effective treatment strategy both with targeted drugs and various chemotherapy regimens.

Detection method: real-time PCR (melting curves)
Material: formalin-fixed and paraffin-embedded tissue (FFPE blocks)
Number of reactions: 48

Analytical sensitivity: 10 copies of the BRCA1, BRCA2 genes in 1 µl of DNA solution
Sensitivity 100 % (with a confidence level of 95 %) 
Specificity 100 % (with a confidence level of 95 %) 

Kits for detection of mutation for prescribing targeted therapy

TestGene is one of the market leaders in oncological test systems. The kits have a high level of sensitivity and specificity and are used by specialists from leading cancer centers in Russia.

TEST-BRAF-TISSUE
Registration certificate No. RZN 2022/17185 dated 16.05.2022
Registration certificate No. RZN 2019/9187 dated 28.12.2022
The kit is used in the examination of patients diagnosed with stage III-IV metastatic melanoma for determination of indications for targeted therapy.

The assay detects 3 mutations in the BRAF gene: V600E and V600E complex (detects but does not differentiate them), V600K.

Detection method: real-time PCR
Material: formalin-fixed and paraffin-embedded tissue (FFPE blocks)
Number of tests: 5 / 24

Analytical sensitivity: 10 copies of the BRAF gene in 1 µl of DNA solution
Sensitivity 89,1 %
Specificity 94,4 %


TEST-EGFR-PLASMA
Registration certificate No. RZN 2017/6267 dated 19.09.2017
The kit is used in the examination of patients diagnosed with non-small cell lung cancer (NSCLC) for determination of indications for targeted therapy with EGFR tyrosine kinase inhibitors and monitoring the response to them.

The assay detects 29 mutations in the EGFR gene: L858R, T790M, 27 deletions (del) in exon 19.

The liquid biopsy method makes it possible to carry out the assay when the tumor material is not available and to constantly monitor the patient's condition and make prompt changes to the treatment program.

Detection method: real-time PCR
Material: blood plasma
Number of tests: 12 / 24

Analytical sensitivity 1 copy of the EGFR gene in 1 µl of DNA solution
Sensitivity 88,1 %
Specificity 96 %


TEST-EGFR-TISSUE
Registration certificate No. RZN 2022/16812 dated 05.04.2022
Registration certificate No. RZN 2018/7670 dated 04.10.2018
The kit is used in the examination of patients diagnosed with non-small cell lung cancer (NSCLC) for determination of indications for targeted therapy with EGFR tyrosine kinase inhibitors and monitoring the response to them.

The assay detects 28 mutations in the EGFR gene: L858R, 27 deletions (del) in exon 19.

Detection method: real-time PCR
Material: formalin-fixed and paraffin-embedded tissue (FFPE blocks)
Number of tests: 5 / 24

Analytical sensitivity: 10 copies of the EGFR gene in 1 µl of DNA solution
Sensitivity 90,9 %
Specificity 94,3 %


TEST-NRAS-TISSUE
Registration certificate No. RZN 2022/17765 dated 15.07.2022
Registration certificate No. RZN 2018/7771 dated 27.12.2022
The kit is used in the examination of patients diagnosed with colorectal cancer for determination of indications for targeted therapy.

The assay detects 8 mutations in the NRAS gene:
Codon 12: Gly12Asp, Gly12Cys, Gly12Ser.
Codon 13: Gly13Asp, Gly13Arg.
Codon 61: Gln61Lys, Gln61Leu, Gln61Arg.

Detection method: real-time PCR
Material: formalin-fixed and paraffin-embedded tissue (FFPE blocks)
Number of tests: 5 / 24

Analytical sensitivity: 10 copies of the NRAS gene in 1 µl of DNA solution
Sensitivity 94,1 % (with a confidence level of 90 %)
Specificity 89,1 % (with a confidence level of 90 %)


TEST-KRAS-TISSUE
Registration certificate No. RZN 2022/16758 dated 29.03.2022
Registration certificate No. RZN 2018/7776 dated 28.12.2022
The kit is used in the examination of patients diagnosed with colorectal cancer for determination of indications for targeted therapy.

The assay detects 7 mutations in the KRAS gene:
Codon 12: Gly12Asp, Gly12Ala, Gly12Arg, Gly12Val, Gly12Ser, Gly12Cys.
Codon 13: Gly13Asp.

Detection method: real-time PCR
Material: formalin-fixed and paraffin-embedded tissue (FFPE blocks)
Number of tests: 5 / 24

Analytical sensitivity: 10 copies of the KRAS gene in 1 µl of DNA solution
Sensitivity 90,9 %
Specificity 95 %


The kits cannot be used for diagnostics of any pathology and are designed only for qualitative determination of the status of mutations to determine indications for targeted therapy.

Kits for diagnostics of oncological diseases

TestGene is one of the market leaders in oncological test systems. The kits have a high level of sensitivity and specificity and are used by specialists from leading cancer centers in Russia.

The kits are designed for early non-invasive diagnostics of prostate cancer and are an additional criterion when prescribing a primary or repeated prostate biopsy to the patient.

Sampling of material for the assay is possible without special preparation of the patient.

PROSTA-TEST
Registration certificate No. RZN 2017/6537 dated 04.12.2017
CE Сertificate ECREP20220718.2
The assay detects the level of expression of the PCA3 gene specific for prostate cancer in relation to the level of the KLK3 gene (PSA) characteristic only for the prostate tissue.

Detection method: real-time RT-PCR
Material: urine
Number of tests: 12 / 24

Analytical sensitivity: 100 copies of RNA
Sensitivity 78,3 %
Specificity 81,5 %


PROSTA-TEST-2.0
The assay detects the chimeric TMPRSS2-ERG gene and determines the level of expression of the PCA3 gene specific for prostate cancer in relation to the level of the KLK3 gene characteristic only for prostate tissue.

The risk of contamination during the assay is reduced due to the inclusion of uracil-DNA-glycosylase (UDG) and 2'-deoxyuridine-5'-triphosphate (dUTP) in the reaction mix.

Detection method: real-time RT-PCR
Material: urine
Number of tests: 12 / 24

Analytical sensitivity: 10 copies/µl
Sensitivity 87,5-100 %
Specificity 100 %

Kits for diagnostics of urogenital infections

Urogenital infections are some of the most common infections. Many cases are asymptomatic or without a characteristic clinical picture. Mixed infections caused by several pathogens are common. TestGene’s kits make it possible to detect pathogens of the most common urogenital infections.

  • Multiple targets in a test tube reduce the chance of making a mistake during the assay.
  • The speed of obtaining the results increases the laboratory capacity.
  • The risk of contamination is reduced due to the inclusion of uracil-DNA-glycosylase (UDG) and 2'-deoxyuridine-5'-triphosphate (dUTP) in the reaction mix.

UROGEN-TEST-5
Registration certificate No. RZN 2022/16620 dated 02.03.2022
The kit is designed for detection of DNA of 5 pathogens of urogenital infections: Mycoplasma genitalium, Ureaplasma urealyticum, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis.

Detection method: real-time PCR
Material: vaginal swabs, cervical / urethral scraping, cell sediment of the 1st portion of freely produced urine, prostate secretion
Number of reactions: 96

Package design options: All 5 infections / Mycoplasma genitalium, Ureaplasma urealyticum / Trichomonas vaginalis, Neisseria gonorrhoeae / Chlamydia trachomatis

Analytical sensitivity: 500 copies/ml
Sensitivity 90-100 %
Specificity 100 %


UROGEN-TEST-12
Registration certificate No. RZN 2022/17261 dated 19.05.2022
The kit is designed for detection of DNA of 12 pathogens of urogenital infections: Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, Ureaplasma urealyticum, Trichomonas vaginalis, Mycoplasma hominis, Ureaplasma parvum, Gardnerella vaginalis, Candida albicans, CMV (Human betaherpesvirus 5), HSV1 (Human alphaherpesvirus 1), HSV2 (Human alphaherpesvirus 2)

Detection method: real-time PCR
Material: vaginal swabs, cervical / urethral scraping, cell sediment of the 1st portion of freely produced urine, prostate secretion
Number of reactions: 96

Package design options:
All 12 infections / Mycoplasma genitalium, Ureaplasma urealyticum, Mycoplasma hominis, Ureaplasma parvum / Trichomonas vaginalis, Neisseria gonorrhoeae, Gardnerella vaginalis, Candida albicans / Chlamydia trachomatis, Human betaherpesvirus 5 (CMV), Human alphaherpesvirus 1 (HSV1), Human alphaherpesvirus 2 (HSV2)

Analytical sensitivity: 500 copies/ml
Sensitivity 100 %
Specificity 100 %

Kits for diagnostics of the respiratory infections

TestGene offers a comprehensive approach to diagnostics of the coronavirus infection:
  • The PCR tests make it possible to determine the presence/absence of the virus RNA in biomaterial, as well as to differentiate the Omicron strain.
  • The diagnostic kit by loop-mediated isothermal amplification (LAMP) provides accurate results without using an amplifier.
  • The rapid test is used for quick detection of the virus in the acute phase of the infection. It is possible to use the kit at the patient's bedside and in conditions of limited access to laboratory diagnostics.
It is also possible to diagnose the influenza A and B viruses additionally using the kits.


LATERAL FLOW TESTS (IMMUNOCHROMATOGRAPHIC)

Advantages of rapid diagnostics:

  • Fast alternative to PCR diagnostics.
  • No additional equipment is required.
  • The infection is detected in the early stages.
  • Wide range of storage temperature (-30 …+30 °С).


GT ANTIGEN COVID-19

Registration certificate No. RZN 2022/18310 dated 23.09.2022
The test is designed for rapid diagnostics of the respiratory viral infection caused by the SARS-CoV-2 coronavirus. The assay detects the N protein fragment in samples.

Material: oropharyngeal / nasopharyngeal swabs
Number of tests: 1 / 25

Sensitivity oropharyngeal swab 98,15 % / nasopharyngeal swab 95,83 %
Specificity 100 %


SARS-COV-2 ANTIGEN HOME TEST
Registration certificate No. RZN 2022/18702 dated 30.10.2022
The test is designed for rapid diagnostics of the respiratory viral infection caused by the SARS-CoV-2 coronavirus for using at home. The assay detects the N protein fragment in samples.

Material: nasopharyngeal swabs
Number of tests: 1 / 5 / 25

Sensitivity 92,73 %
Specificity 100 %


SARS-COV-2 ANTIGEN HOME TEST
Registration certificate No. RZN 2022/17694 dated 08.07.2022
The test is designed for rapid diagnostics and differentiation of the most dangerous respiratory viral infections: coronavirus and influenza A and B

The assay detects: SARS-CoV-2 - N protein / Influenza A  - M1 protein / Influenza B - NP protein

Material: oropharyngeal / nasopharyngeal swabs
Number of tests: 25

Sensitivity oropharyngeal swab 89,66-92 % / nasopharyngeal swab 92-96 %
Specificity 100 %



PCR TESTS

COV-INFLU-TEST
Registration certificate No. RZN 2022/18927 dated 23.09.2022
The kit is designed for diagnostics of the respiratory viral infection caused by the
SARS-CoV-2 coronavirus and influenza A and B viruses.

Detection of the SARS-CoV-2 virus using 2 targets.
Detection of all known strains of the influenza A and B.

Material: oropharyngeal / nasopharyngeal swabs, sputum
Number of tests: 96

Analytical sensitivity: 1000 copies/ml
Sensitivity 100 %
Specificity 100 %


COV-2-FAST-TEST
Registration certificate No. RZN 2022/18670 dated 31.10.2022
The kit is designed for diagnostics of the respiratory viral infection caused by the SARS-CoV-2 coronavirus. The assay is carried out in one test tube and detects the N gene fragment – the conservative part of the gene that is not exposed to mutations.

Isolation of RNA from clinical material is not require, which makes it possible to obtain a reliable result in 90 minutes and significantly increase the laboratory capacity.

Detection method: real-time RT-PCR without the isolation step
Material: oropharyngeal / nasopharyngeal swabs
Number of tests: 96

Analytical sensitivity: 600 copies/ml
Sensitivity 94-100 %
Specificity 91,2-100 %


COV-2-TEST
Registration certificate No. RZN 2020/10364 dated 15.05.2020
The kit is designed for diagnostics of the respiratory viral infection caused by the SARS-CoV-2 coronavirus. The assay is carried out in one test tube and detects the N gene fragment – the conservative part of the gene that is not exposed to mutations.

Detection method: real-time RT-PCR
Material: oropharyngeal / nasopharyngeal swabs
Number of tests: 96

Package design options: with the RNA extraction kit / without the RNA extraction kit

Analytical sensitivity: 500 copies/ml
Sensitivity 96-100 %
Specificity 96-100 %


COV2-DIF-O
Registration certificate No. RZN 2022/16531 dated 10.02.2022
The kit is designed for diagnostics of the respiratory viral infection caused by the SARS-CoV-2 coronavirus with differentiation of the B.1.1.529 variant (Omicron). The assay is carried out in one test tube and detects the gene N, including mutations Δ31-33 in the Omicron N gene.

Detection method: real-time RT-PCR with the isolation / without the isolation stage
Material: oropharyngeal / nasopharyngeal swabs
Number of tests: 96

Package design options: without RNA extraction / with the RNA extraction kit / without the RNA extraction kit

Analytical sensitivity: 600 copies/ml complete with RNA extraction / 1000 copies/ml complete without RNA extraction
Sensitivity 94,5 %
Specificity 96,9 %



LOOP-MEDIATED ISOTHERMAL AMPLIFICATION (LAMP) 

Advantages of the assay:

  • RNA isolation is not necessary.
  • The IC sample is included in the kit for control of false negative results.
  • Visual interpretation of the assay results.
  • Reliable result in 25 minutes.

COV-2-COLOR-TEST
Registration certificate No. RZN 2022/16662 dated 10.03.2022
The kit is designed for diagnostics of the respiratory viral infection caused by the SARS-CoV-2 coronavirus. The assay is carried out using a thermostat or an amplifier and detects the N gene fragment.

Detection method: LAMP
Material: oropharyngeal / nasopharyngeal swabs
Number of reactions: 92

Analytical sensitivity: 2,5х104 copies/ml with RNA extraction / 105copies/ml without RNA extraction
Sensitivity 100 %
Specificity 100 %


The test systems are highly specific, constantly undergo relevant tests and detect all known strains of SARS-CoV-2.

Kits for diagnostics of hepatitis

Hepatitis B, C, D are the most significant among viral hepatitis. The use of PCR tests in their diagnostics makes it possible to:

  • diagnose the disease, determine its form and phase;
  • determine the viral load;
  • decide on the start of the therapy and monitor its effectiveness.

HEPA-BCD-TEST
Registration certificate No. RZN 2022/16782 dated 29.03.2022
The kit is designed for detection and differentiation of the hepatitis B, C and D viruses in patients with suspected infection. Qualitative detection of the specific regions of the genomic DNA of the hepatitis B virus and the RNA of the hepatitis C and D viruses is performed in one test tube during the assay.

Possible joint testing with the kits "HEPA-C-ТЕSТ-Q", "HEPA-B-ТЕSТ-Q", "HEPA-D-ТЕSТ-Q", "HEPA-CGENE-ТЕSТ", "HIV-1-ТЕSТ-Q" and "HIV-ТЕSТ" 

Detection method: real-time RT-PCR
Material: blood plasma
Number of tests: 96

Analytical sensitivity: hepatitis B - 48 IU/ml / hepatitis C - 100 IU/ml when isolating from 100 µl of plasma
Sensitivity 100 %
Specificity 100 %


HEPA-B-TEST-Q
Registration certificate No. RZN 2022/16949 dated 18.04.2022
The kit is designed for quantitative detection of the hepatitis B virus DNA in patients with suspected infection and determination of the viral load in patients with the detected hepatitis B virus to choose the appropriate therapy and evaluate its effectiveness.

The risk of contamination during the assay is reduced due to the inclusion of uracil-DNA-glycosylase (UDG) and 2'-deoxyuridine-5'-triphosphate (dUTP) in the reaction mix.

Possible joint testing with the kits "HEPA-BCD-ТЕSТ", 'HEPA-C-ТЕSТ-Q", 'HEPA-D-ТЕSТ-Q", "HEPA-CGENE-ТЕSТ", "HIV-1-ТЕSТ-Q" and "HIV-ТЕSТ".

Detection method: real-time PCR
Material: blood plasma
Number of tests: 96

Analytical sensitivity: 47 IU/ml when isolating from 100 µl of plasma / 4,7 IU/ml when isolating from 1000 µl of plasma
Sensitivity 100 %
Specificity 100 %


HEPA-C-TEST-Q
Registration certificate No. RZN 2022/16797 dated 01.04.2022
The kit is designed for quantitative detection of the hepatitis C virus RNA in patients with suspected infection and patients with the detected hepatitis C virus in order to choose the appropriate therapy and evaluate its effectiveness.

Possible joint testing with the kits "HEPA-BCD-ТЕST", "HEPA-B-ТЕSТ-Q", "HEPA-D-ТЕSТ-Q", "HEPA-CGENE-ТЕSТ", "HIV-1-ТЕSТ-Q" and "HIV-ТЕSТ".

Detection method: real-time RT-PCR
Material: blood plasma
Number of tests: 96

Analytical sensitivity: 48 IU/ml when isolating from 100 µl of plasma / 7 IU/ml when isolating from 1000 µl of plasma
Sensitivity 100 %
Specificity 100 %


HEPA-D-TEST-Q
Registration certificate No. RZN 2022/18686 dated 09.11.2022
The kit is designed for qualitative and quantitative detection of hepatitis D virus
RNA in patients with suspected infection and determination of viral load in patients
with detected hepatitis D virus to choose the correct therapy and evaluate its
effectiveness.

Possible joint testing with the kits "HEPA-BCD-TEST", "HEPA-C-TEST-Q", "HEPA-B-TEST-Q", "HEPA-C-GENE-TEST","HIV-1-TEST-Q" and "HIV-TEST".

Detection method: real-time PCR
Material: blood plasma
Number of tests: 96

Analytical sensitivity: 
Qualitative detection 40 IU/ml when isolated from 100 µl of plasma / 9 IU/ml when isolated from 1000 µl of plasma
Quantitative detection 113 IU/ml when isolated from 100 µl of plasma / 13 IU/ml when isolated from 1000 µl of plasma

Sensitivity 100 %
Specificity 100 %


HEPA-C-GENE-TEST
Registration certificate No. RZN 2022/18556 dated 14.10.2022
The kit is designed for detection of the hepatitis C virus and its genotypes (1a, 1b, 2, 3, 4, 5a, 6) in patients with the detected virus to choose an appropriate antiviral therapy, to predict and evaluate the course of the disease and possible complications.

Possible joint testing with the kits "HEPA-BCD-ТЕST", "HEPA-B-ТЕSТ-Q", "HEPA-C-ТЕSТ-Q", "HEPA-DТЕSТ-Q", "HIV-1-ТЕSТ-Q" and "HIV-ТЕSТ".

Detection method: real-time RT-PCR
Material: blood plasma
Number of tests:  92 (HEPA-C-GENE-test-AB) / 94 (HEPA-C-GENE-test-A)

Analytical sensitivity: 77 copies/ml when isolating from 1 000 µl of plasma / 1500 IU/ml when isolating from 100 µl of plasma
Sensitivity 100 %
Specificity 100 %

Kits for diagnostics of the human immunodeficiency virus

The HIV infection, caused by the HIV-1, HIV-2 viruses, has a devastating effect on the human immune system. Without timely diagnostics and treatment, HIV leads to death due to the activation of opportunistic infections or the development of tumors. The PCR test makes it possible to detect even single viral particles and is used in clinical practice in the following cases:

  • early diagnostics of the HIV infection before the appearance of antibodies;
  • diagnostics of the HIV status in children born to HIV-infected mothers;
  • selection of treatment tactics and assessment of the effectiveness of the antiretroviral therapy;
  • additional assay to exclude a misdiagnosis;
  • operational examination of donor blood.  .

HIV-TEST
Registration certificate No. RZN 2022/16782 dated 29.03.2022
The kit is designed for detection and differentiation of human immunodeficiency viruses type 1 and 2 (HIV-1 and HIV-2) in order to diagnose the HIV infection and choose an antiretroviral therapy regimen. The assay detects the pol gene fragment (HIV-1) / 5` and 3` LTR fragments (HIV-2) in samples.

Possible joint testing with the kits "HEPA-BCD-ТЕST", "HEPA-B-ТЕSТ-Q", "HEPA-C-ТЕSТ-Q", "HEPA-D-ТЕSТ-Q", "HEPA-C-GENE-ТЕSТ", "HIV-1-ТЕSТ-Q".

Detection method: real-time RT-PCR
Material: blood plasma
Number of tests: 96

Analytical sensitivity: at least 20 copies/ml of plasma when isolated from 1000 µl
of plasma and 50 µl elution volume
Sensitivity HIV-1: 98,70-100 % / HIV-2: 95,49-100 %
Specificity 95,14-100 %


HIV-1-TEST-Q
Registration certificate No. RZN 2022/19314 dated 30.12.2022
The kit is designed for quantitative detection of the human immunodeficiency virus (HIV-1) in order to diagnose the HIV infection, choose an antiretroviral therapy regimen, monitor the progression of the HIV infection and/or the effectiveness of the antiretroviral therapy, and is also recommended for dispensary registration. The assay detects the pol gene fragment in samples.

Possible joint testing with the kits "HEPA-BCD-ТЕST", "HEPA-B-ТЕSТ-Q", "HEPA-C-ТЕSТ-Q", "HEPA-D-ТЕSТ-Q", "HEPA-C-GENE-ТЕSТ", "HIV-ТЕSТ".

Detection method: real-time RT-PCR
Material: blood plasma
Number of tests: 88

Analytical sensitivity: at least 20 copies/ml of plasma when isolated from 1000 µl of plasma and 50 µl elution volume
Sensitivity 98,7-100 %
Specificity 95,14-100 %

Kits for diagnostics of tuberculosis and determination of the antimicrobial resistance

MTB-TEST
The kit is designed for detection of the tuberculosis and non-tuberculosis complex mycobacteria and their differentiation in patients with suspected pulmonary and extrapulmonary tuberculosis, mycobacteriosis.

The assay is carried out in one test tube per patient and detects mycobacterium tuberculosis complex (М. tuberculosis, M. bovis, M. bovis BCG, M. africanum, M. canettii, M. caprae, M. microti) and nontuberculous mycobacteria (M. avium, M. abscessus, M.septicum, M. fortuitum, M. gordonae, M. intracellulare, M. kansasii, M. marinum, M. smegmatis, M. xenopi, M. ulcerans, M. terrae), Mycolicibacterium spp., and Mycobacteroides spp.

The risk of contamination during the assay is reduced due to the inclusion of uracil-DNA-glycosylase (UDG) and 2'-deoxyuridine-5'-triphosphate (dUTP) in the reaction mix.

Detection method: real-time PCR
Material: sputum, bronchoalveolar lavage, bronchial washing, gastric washing, pleural fluid, blood, urine, microbiological cultures, prostate secretion, tissue (biopsy and surgical) material, synovial fluid, pericardial fluid and cerebrospinal fluid, washings from environmental objects.
Number of reactions: 96

Analytical sensitivity: from 100 copies/ml
Sensitivity 100 %
Specificity 100 %


MTB-RESIST-I-TEST
The kit is designed for detection of mutations associated with drug resistance in the tuberculosis complex mycobacteria DNA with determination of sensitivity to the first-line chemotherapy drugs and their analogues. The result of the assay allows for choosing of an appropriate therapy for patients with the confirmed diagnosis of pulmonary and extrapulmonary tuberculosis.

The resistance of mycobacteria of the tuberculosis complex in relation to the drugs rifampicin (rpoB), isoniazid (katG and inhA) and their analogues is revealed:
rpoB: polymorphisms of codons 510-533, D516V, D516Y, codon 526, L533R, L533P, S531L
katG: polymorphisms S315T, S315N, S315R, S315I
inhA: polymorphism C-15T and polymorphisms of the region -20 – +6 are also detected but not differentiated

Detection method: real-time PCR (melting curves)
Material: sputum, bronchoalveolar lavage, bronchial lavage, gastric lavage, pleural fluid, blood, urine, cultures of microorganisms, prostate secretion, tissue (biopsy and surgical) material, synovial fluid, pericardial fluid and cerebrospinal fluid.
Number of reactions: 96

Analytical sensitivity: at least 5 000 copies of genomic DNA per 1 ml of biomaterial
Sensitivity 100 %
Specificity 100 %


MTB-RESIST-II-TEST
The The kit is designed to detect polymorphisms associated with drug resistance to second-line chemotherapy drugs (aminoglycosides and fluoroquinolones) and their analogues. The result of the assay makes it possible to choose the appropriate therapy for patients with a confirmed diagnosis of pulmonary and extrapulmonary tuberculosis.

The resistance of the Mycobacterium tuberculosis complex to aminoglycosides (rrs and eis gene polymorphisms) and fluoroquinolones (gyrA and gyrB gene polymorphisms) and their analogs is detected:
rrs: 1401A>G, 1402C>T and 1484G>T;
eis: C-14G, C-14T, C-12T, G-10C, G-10A and G-37T;
gyrA: p.G88C, p.A90V, p.S91P, p.D94G, p.D94N, p.D94H, p.D94A and p.D94Y;
gyrB: p.D461H, p.D461N, p.N499D, p.E501V and p.A504V

Detection method: real-time PCR (melting curves)
Material: sputum, bronchoalveolar lavage, bronchial lavage, gastric lavage, pleural fluid, blood, urine, cultures of microorganisms, prostate secretion, tissue (biopsy and surgical) material, synovial fluid, pericardial fluid and cerebrospinal fluid.
Number of reactions: 12 / 96

Analytical sensitivity: at least 2 000 copies of genomic DNA per 1 ml of biomaterial
Sensitivity 100 %
Specificity 100 %

Kits for diagnostics of tropical diseases

Malaria, Dengue fever, Zika fever and Chikungunya are diseases with a transmissible passing mechanism. All of these diseases are quite serious and characterized by development of severe symptoms. At the same time, the symptoms of these diseases are similar, so it can be difficult or impossible to differentiate between them without laboratory tests. It is necessary to differentiate between them to prescribe the correct treatment. An infection is to be suspected in patients with typical clinical manifestations and an epidemiological history (living or traveling to regions of the habitat of mosquitoes, unprotected sexual contact with a person living in an endemic area). The diagnosis is made on the basis of PCR tests with detection of the virus RNA.


PLASMODIUM-TEST-Q
The kit is recommended for use in patients with clinical symptoms of malaria with a suspected infection caused by representatives of the Plasmodium genus (P.falciparum, P.vivax, P.malariae, P.ovale curtisi, P.ovale wallikeri and P.knowlesi).

The use of the enzyme uracil-DNA-glycosidase prevents obtaining false-positive results in case of contamination with amplification products.

Detection method: real-time PCR
Material: whole blood
Number of reactions: 96

Analytical sensitivity: 500 IU/ml
Sensitivity 100 %
Specificity 100 %


PLASMODIUM-SPECIES-TEST
The The kit is recommended for use in patients with clinical symptoms of malaria with a suspected infection caused by representatives of the Plasmodium genus (P.falciparum, P.vivax, P.malariae, P.ovale curtisi, P.ovale wallikeri).

Configurations: DNA RNA isolated from human whole blood. 

Detection method: real-time PCR (DNA) / real-time RT-PCR (RNA)
Material: whole blood.
Number of tests: 96

Analytical sensitivity: 500 IU of DNA / 500 IU of RNA
Sensitivity 100 %
Specificity 100 %


DENV-TEST
It is intended for use in patients with clinical symptoms of a viral disease with a suspected infection caused by Dengue virus. Specific in relation to RNA of Dengue virus (types 1-4).

Configurations: with RNA isolation  / without RNA isolation. 

Detection method: real-time RT-PCR
Material: blood plasma.
Number of  reactions: 96

Analytical sensitivity: 500 copies/ml – with RNA isolation / 1000 copies/ml – without RNA isolation
Sensitivity 100 %
Specificity 100 %


ZIK-TEST
It is intended for use in patients with clinical symptoms of a viral disease with a suspected infection caused by Zika virus.

Configurations: with RNA isolation  / without RNA isolation. 

Detection method: real-time RT-PCR
Material: blood plasma.
Number of  reactions: 96

Analytical sensitivity: 500 copies/ml – with RNA isolation / 1000 copies/ml – without RNA isolation
Sensitivity 100 %
Specificity 100 %


CHIK-TEST
It is intended for use in patients with clinical symptoms of a viral disease with a suspected infection caused by Chikungunya virus.

Configurations: with RNA isolation  / without RNA isolation. 

Detection method: real-time RT-PCR
Material: blood plasma.
Number of  reactions: 96

Analytical sensitivity: 500 copies/ml – with RNA isolation / 1000 copies/ml – without RNA isolation
Sensitivity 100 %
Specificity 100 %


TROPIC-TEST
It is intended for use in patients with clinical symptoms of a viral disease with a suspected infection caused by Chikungunya, Zika, Dengue viruses.

Configurations: with RNA isolation  / without RNA isolation. 

Detection method: real-time RT-PCR
Material: blood plasma.
Number of  reactions: 96

Analytical sensitivity: 500 copies/ml – with RNA isolation / 1000 copies/ml – without RNA isolation
Sensitivity 100 %
Specificity 100 %

Kits for diagnostics of infections caused by staphylococci

LAMP-STAPH-TEST
Registration certificate RC No. RZN 2022/18662 dated 01.11.2022
The kit is designed for qualitative detection Staphylococcus aureus, with optional DNA isolation and reliable result in 35 minutes.

Detection method: LAMP
Material: DNA preparations isolated from oropharyngeal swabs, urine, sputum, blood, punctates from lesions of organs and tissues), environmental objects (washings from medical equipment and tools), as well as native clinical material — oropharyngeal swabs, washings from medical equipment and tools.
Number of reactions: 96

Analytical sensitivity: 2,5*103 copies/ml with DNA isolation / 2,5*104 copies/ml without DNA isolation
Sensitivity 100 %
Specificity 100 %


Kits for diagnostics of herpes simplex virus infections

HHV6-ТЕSТ 
Registration certificate RC No. RZN 2023/19345 dated 13.01.2023
The kit is designed for qualitative and quantitative detection of human herpes simplex virus type 6 (HHV-6) DNA. It is used when examining patients with suspected herpes simplex virus infection and a confirmed diagnosis to assess viral load and evaluate the effectiveness of treatment. Identification of herpes simplex virus infection caused by HHV-6 is possible in any
form and stage of the disease.

The risk of contamination is reduced due to the inclusion of uracil-DNA-glycosylase (UDG) and 2'-deoxyuridine-5'-triphosphate (dUTP) in the reaction mixture.

Detection method: real-time PCR
Material: whole blood, white blood cells, oropharyngeal swabs, saliva, visceral biopsies, cerebrospinal fluid, urine.
Number of reactions: 96

Analytical sensitivity: 400 IU/ml
Sensitivity 100 %
Specificity 100 %

Kits for non-invasive prenatal diagnostics

Early non-invasive determination of the sex of the fetus and timely prevention of the hemolytic disease of the fetus and newborn (HDFN) in Rh-negative women are of great importance for reducing prenatal morbidity and mortality and assessment of the risk of genetic diseases.
The method is based on the determination of fetal DNA in the mother's blood plasma. The test can be carried out already from the 10th embryological week.


TEST-SRY PLUS
Registration certificate No. RZN 2017/6537 dated 04.12.2017
CE Certificate ECREP20220718.2
The kit is designed for non-invasive diagnostics of the sex of a child by detecting the sex-determining gene (SRY) of the fetus in blood plasma of a pregnant woman. The method is based on determination of the fetal DNA in the mother's blood plasma.The test can be performed starting already from the 10th embryological week.

Detection of the SRY gene indicates pregnancy with a male fetus, if this gene was not detected – a female fetus.

Detection method: real-time PCR
Material: blood plasma
Number of tests: 50 / 100

Analytical sensitivity 10 genomic equivalents/µl
Sensitivity 98,76 %
Specificity 99,88 %


TEST-RHD
Registration certificate No. RZN 2015/2703 dated 03.02.2016
The kit is designed for non-invasive detection of the fetal Rh factor (RHD) gene
in blood plasma of an Rh-negative mother to predict the risk of developing Rh
incompatibility and HDFN. The determination of the Rh factor lies in detection of the RHD gene encoding the D-antigen. The level of accuracy of the assay is achieved by using 3 exons of the RHD gene as targets (6, 7, 10). The method is based on determination of fetal DNA in the mother's blood plasma. The test can be performed starting already from the 10th embryological week.

Detection method: real-time PCR
Material: blood plasma
Number of tests: 50 / 100

Analytical sensitivity 10 genomic equivalents/µl
Sensitivity 99,8 %
Specificity 97,5 %

Kits for DNA/RNA isolation from human clinical material

TestGene's NA isolation kits are suitable for use with analytical stations from various manufacturers and provide consistent high yields of DNA/RNA. Isolation takes place on the basis of spin-column, magnetic particle and thermal lysis technologies.

Isolation kits are designed according to the needs of different laboratories. The range includes
kits for isolation of human and plant NA:

• kits for manual and automated isolation;
• dispensed and not dispensed versions of the kits;
• versatile kits for various biological materials and kits for isolation of NA from blood plasma and tissue.


NA-EXTRA
Registration certificate No. RZN 2021/15428 dated 24.09.2021
CE Certificate ECREP20220718.2
The kit is designed for DNA/RNA isolation from human clinical material by the method based on magnetic particles for subsequent PCR tests.

Package design options: for manual isolation and isolation using automated sample preparation stations / not poured kit for automated isolation / poured kit for automated isolation.

Basic technology: magnetic particles
Material: venous blood, venous blood plasma, sputum, nasopharyngeal swabs, oropharyngeal swabs, vaginal swabs, cervical scraping, urethral scraping, urine cell sediment, prostate secretion
Number of isolation procedures: 96

Efficiency of NA isolation from 25 %
Purity of the isolated NA, А260/280 from 1,7


NA-EXTRA-PLATE
Registration certificate  No. RZN 2022/17579 dated 22.06.2022
The kit is designed for semi-automatic simultaneous extraction of DNA/RNA from human clinical material by the method based on magnetic particles for the subsequent PCR test.

Recommended for use in laboratories with a large flow of analyzes in the absence of automated stations for DNA/RNA extraction.

Basic technology: magnetic particles
Material: venous blood, venous blood plasma, sputum, nasopharyngeal swabs, oropharyngeal swabs, vaginal swabs, cervical scraping, urethral scraping, urine cell sediment, prostate secretion
Number of isolation procedures: 96

Efficiency of NA isolation from 25 %
Purity of the isolated NA, А260/280 from 1,7


DNA-PLASMA-М
Registration certificate No. RZN 2017/6140 dated 23.08.2017
Number of extraction procedures: 50 / 100

DNA-PLASMA-М-RT
Registration certificate No. RZN 2019/9185 dated 07.11.2019
CE Certificate ECREP20220718.2
Number of extraction procedures: 25 / 50

The kits are designed for isolation of human DNA from plasma samples by the method based on the reversible binding of nucleic acids on the surface of magnetic particles for subsequent analysis. The assay can be performed using automatic stations from various manufacturers.

Basic technology: magnetic particles
Material: blood plasma

DNA extraction efficiency from 25 %
Purity of the isolated DNA, А260/280 from 1,6


DNA-TISSUE-М
Registration certificate No. RZN 2021/14273 dated 06.05.2022
CE CERTIFICATE ECREP20220718.2
The kits are designed for isolation of human DNA from tissue samples by the method based on sample lysis, binding of nucleic acids to the surface of magnetic particles.

Basic technology: magnetic particles
Material: formalin-fixed and paraffin-embedded tissue (FFPE blocks)
Number of extraction procedures: 50 / 100

DNA extraction efficiency from 20 %
Purity of the isolated DNA, А260/280 from 1.7


DNA-TISSUE-F
Registration certificate RC No. RZN 2018/7772 dated 30.10.2018
The kit is designed for isolation of human DNA from tissue samples by the method based on the binding of nucleic acids to the silicate membrane in the spin column for the subsequent analysis.

Basic technology: spin columns
Material: formalin-fixed and paraffin-embedded tissue (FFPE blocks)
Number of extraction procedures: 50 / 100

DNA extraction efficiency from 20 %
Purity of the isolated DNA, А260/280 from 1,6


DNA-FAST
Registration certificate No. RZN 2021/14885 dated 27.07.2021
CE Certificate ECREP20220718.2 
The kit is designed for collection, transportation and isolation of DNA from clinical material. It is recommended to transfer the test tubes with the DNA-FAST reagent included in the kit to the treatment rooms of clinics as a container for collection, storage and transportation of biological material for PCR analysis.

Basic technology: thermal lysis
Material: nasopharyngeal swabs, oropharyngeal swabs, vaginal swabs, cervical scraping, urethral scraping, urine cell sediment, saliva, cerebrospinal fluid, synovial fluid, prostate secretion.
Number of extraction procedures: 100

Efficiency of DNA isolation from 20 %