Kits of reagents for molecular genetic

Download catalog TestGene production

Kits for determination of predisposition to hereditary 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.

HRR SCREENING
Registration certificate No. RZN 2022/16592 dated 22.02.2022
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
The kit is designed for detection of germline and somatic mutations in the BRCA1, BRCA2 genes and is recommended for determination of predisposition to the development of hereditary forms of breast and ovarian cancer in healthy women and during examination of patients diagnosed with breast and ovarian cancer in order to determine an effective treatment strategy.

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: 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 tactics in cancer treatment

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 No. RZN 2022/16592 dated 22.02.2022
The kit detects 16 germline mutations and is used in the diagnostics of hereditary forms of breast, ovarian, pancreatic, and stomach cancer for determination of 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 %
Specificity 100 %


BRCA1,2-TISSUE
Registration certificate No. RZN 2022/17324 dated 24.05.2022
The kit detects 16 somatic mutations and is used in the examination of patients with hereditary forms of breast, ovarian, pancreatic, and stomach cancer. The assay makes it possible to predict the course of the disease and determine an effective treatment strategy with both 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 %
Specificity 100 %

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 07.11.2019
CE-MARK NO. CMC/CE/2020/03122020.4
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
CE-MARK NO. CMC/CE/2020/04022021.12
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 3 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
CE-MARK NO. CMC/CE/2020/03122020.5
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 2 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 2017/6267 dated 19.09.2017
CE-MARK NO. CMC/CE/2020/04022021.12
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: 24

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


TEST-KRAS-TISSUE
Registration certificate No. RZN 2022/16758 dated 29.03.2022
Registration certificate No. RZN 2017/6267 dated 19.09.2017
CE-MARK NO. CMC/CE/2020/04022021.12
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-MARK NO. CMC/CE/2020/15032021.4
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 83,33-100 %
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: 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:
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 90-100 %
Specificity 100 %

Kits for diagnostics of the coronavirus infection

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.


SARS COV-2 ANTIGEN TEST
Registration certificate No. RZN 021/15499 dated 07.10.2021
The test is designed for rapid diagnostics of the respiratory viral infection caused by the SARS-CoV-2 coronavirus and is a fast alternative to PCR diagnostics. The assay detects the N protein fragment in samples.

Advantages of rapid diagnostics:

  • No additional equipment is required.
  • The infection is detected in the early stages.
  • Wide range of storage temperature.

Detection method: lateral flow test
Material: oropharyngeal / nasopharyngeal swabs
Number of tests: 25

Sensitivity 96 %
Specificity 100 %


CITO-COV-2-TEST
Registration certificate No. RZN 2022/17319 dated 24.05.2022
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 protein fragment – the conservative part of the gene that is not exposed to mutations.

RNA extraction from clinical material is not required for the assay, 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 extraction stage
Material: oropharyngeal / nasopharyngeal swabs
Number of tests: 96

Analytical sensitivity: 500 copies/ml
Sensitivity 94,5 %
Specificity 96,9 %


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 protein 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 N protein fragment 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: 500 copies/ml with RNA extraction / 1000 copies/ml without RNA extraction
Sensitivity 94,5 %
Specificity 96,9 %


COV-INFLU-TEST
The kit is designed for diagnostics of the respiratory viral infection caused by the SARS-CoV-2 coronavirus and the influenza A and B viruses. The assay is carried out in one test tube and detects 2 SARS-CoV-2 targets (the N and RdRp gene fragments), the M1 influenza A gene fragment and the NP influenza B gene fragment.

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

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


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.

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.

Detection method: LAMP
Material: oropharyngeal / nasopharyngeal swabs
Number of tests: 96

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-TEST-Q», «HEPA-B-TEST-Q», «HEPA-C-GENE-TEST».

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

Analytical sensitivity: from 25 copies/ml of plasma / from ~48 IU/ml
Sensitivity 100 %
Specificity 100 %


HEPA-C-TEST-Q
Registration certificate No. RZN 2022/16798 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-TEST», «HEPA-B-TEST-Q», «HEPA-C-GENE-TEST».

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

Analytical sensitivity: from 25 copies/ml of plasma / 48 IU/ml
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-TEST», «HEPA-C-TEST-Q», «HEPA-C-GENE-TEST».

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

Analytical sensitivity: 47 IU/ml
Sensitivity 100 %
Specificity 100 %


HEPA-C-GENE-TEST
The kit is designed for detection of the hepatitis C virus and its genotypes (1a, 1b, 2, 3, 4, 5, 6) in patients with the detected virus to choose the appropriate antiviral therapy and make a predictive evaluation of the course of the disease and possible complications.

Possible joint testing with the kits «HEPA-BCD-TEST», «HEPA-C-TEST-Q», «HEPA-B-TEST-Q».

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

Analytical sensitivity: 200 copies/ml / 1500 IU/ml
Sensitivity 100 %
Specificity 100 %

Kits for diagnostics of tuberculosis and determination of the antimicrobial resistance

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

The assay is carried out in one test tube and detects Mycobacterium, Mycolicibacterium and Mycobacteroides with differentiation of the Mycobacterium tuberculosis complex: М. tuberculosis, M. bovis, M. bovis BCG, M. africanum, M. canettii, M. caprae, M. microti

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 of the mycobacterium tuberculosis complex DNA with determination of the sensitivity to the first-line chemotherapy drugs 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 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 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: at least 5,000 copies of genomic DNA per 1 ml of biomaterial
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
Registration certificate No. RZN 2017/6537 dated 04.12.2017
CE-MARK NO. CMC/CE/2020/15032021.4
The test system is designed for non-invasive diagnostics of the sex of a child by detecting the sex gene (SRY) of the fetus in the blood plasma. The detection of the SRY gene indicates pregnancy with a male fetus, if this gene is not detected, the fetus is female.

The assay is of particular importance for families at risk of developing a sex-linked disease.

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 test system is designed for non-invasive detection of the fetal Rh factor gene (RHD) in the blood plasma of an Rh-negative mother to predict the risk of developing an Rh incompatibility and the 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 risk of developing an Rh incompatibility is identified during the assay to determine the tactics of managing an Rh-negative pregnancy while saving more than 30% of the budget.

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 %

Kits for DNA/RNA isolation from human clinical material

The sample preparation step is of great importance for obtaining correct PCR results. Therefore, it is very important to use proven reliable reagents for isolation of nucleic acids. Only the optimal concentration and high quality of nucleic acids can unleash 100% potential of any PCR diagnostic method.

TestGene’s kits for NA isolation are suitable for use with analytical stations of various manufacturers and provide a stable high yield of DNA/RNA. The isolation is based on spin-column, magnetic particle and thermal lysis technologies.

The isolation kits are designed taking into account the needs of different laboratories:

  • kits for manual and automated isolation;
  • open and unopened variants of the kits;
  • universal kits for various biological materials and kits for NA isolation from blood plasma and tissue.

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

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

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

NA extraction efficiency 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-MARK NO. CMC/CE/2021/29092021.1
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 the subsequent analysis. It is possible to carry out the assay using automated stations of 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 2017/6140 dated 23.08.2017
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 No. RZN 2019/9185 dated 07.11.2019
CE-MARK NO. CMC/CE/2021/29092021.1
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
The kit is designed for collection, transportation and isolation of DNA from clinical material. The test tubes with the DNA-Fast reagent included in the kit are recommended to be transferred to the treatment rooms of clinics as containers 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

DNA extraction efficiency from 20%