DiagnoVTM and DiagnoVTM v2.0 are designed to collect clinical samples containing virus from the area where secretions from the nasal cavity (nasopharynx) and throat (oropharynx) are collected and transported to the test laboratory. Samples collected with swabs are stored in this viral transport medium. It can be used for virus testing and isolation in the laboratory with the Polymerase Chain Reaction (PCR) method.
Country of Origin: Turkey
CE IVD
Quantity of tests/ units per kit: 100
Diagnovital SARS-CoV-2 is a Real-Time Qualitative RT-PCR-based test used for the detection of SARS-CoV-2. - It can detect nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swabs and BAL human samples.
Diagnovital SARS-CoV-2 test allows extraction and purification of the nucleic acid genome of SARS-CoV-2 followed by PCR amplification and detection.
Selective amplification of target nucleic acid from the sample is achieved through target-specific forward and reverse primers and probes specific to the SARS-CoV-2 envelope gene (E-gene) and the polymerase gene (RdRP). The RdRP gene target is detected by one probe, unique to SARS-CoV-2. Additionally, a conserved region in the structural protein envelope E-gene was chosen also for the pan-Sarbecovirus detection. The pan-Sarbecovirus detection sets will also detect SARS-CoV-2 virus.
Selective amplification of Internal Control is achieved through non-competitive, sequence specific forward and reverse primers and a probe for the endogeneous human RNAseP gene which have no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for amplification.
Validation and Certification - Diagnovital SARS-CoV-2 Real-Time PCR Kit has been validated for use with RTA Viral Nucleic Acid Isolation Kit or RTA Viral RNA Isolation Kit.
Diagnovital Real Time PCR Kits are certified and marked with CE-IVD to meet specific quality and purity requirements of in-vitro diagnostic use.
The kit follows CDC’s and WHO’s latest detection guidelines.
Country of Origin: Turkey FDA Owner/Operator Number: 10071895 FDA
CE IVD – FDA EUA listed
Quantity of tests/ units per kit: 100
Isolation of high-purity viral RNA from serum and plasma samples is essential for clinical diagnosis and molecular research. RTA Viral RNA Isolation Kit provides a rapid and simple method for isolation of highly pure viral RNA from virus containing cell-free body fluids. High efficiency and purity is achieved by the end of the isolation process. Due to the simple procedure of the kit that requires only basic laboratory equipment, it is possible to isolate viral RNA from various samples simultaneously.
Country of Origin: Turkey
CE IVD - FDA Status: under listing FDA
Quantity of tests/ units per kit: 100
General - Cirrus ELISA SARS-CoV-2 ELISA kit is an antibody kit is used for qualitative detection of human IgM and IgG antibodies against SARS-CoV-2 in human serum, plasma and whole blood samples.
Description – The kit is a reliable and automation friendly COVID-19 ELISA test, allowing for comprehensive and accurate IgG and IgM antibody assessment.
Principle - Diluted patient serum is added to wells coated with purified COVID-19 antigen. SARS-CoV-2 IgG and IgMspecific antibody, if present, binds to the antigen. All unbound materials are washed away, and the enzyme conjugate is added to bind to the antibody-antigen complex, if present. Excess enzyme conjugate is washed off and substrate is added. The plate is incubated to allow the oxidation of the substrate by the enzyme. The intensity of the color generated is proportional to the amount of IgG specific antibody in the sample.
Validation and certification – The test kit is a CE-marked Enzyme Immunoassay (ELISA) kit.
Country of Origin: USA
FDA Status: Listed
Quantity of tests/ units per kit: 100
Respirator, Surgical masks
Country of Origin: China or Turkey
CE IVD - FDA Status: Listed (China); NA (Turkey)
Quantity of tests/ units per kit: 50
General – Cirrus SARS-CoV-2 IgM/IgG is an IgM/IgG antibody test kit.
Description - With advanced lateral flow immunochemical device and a proprietary antibody mix, this test kit can detect all COVID-19 antibodies in a convenient, rapid and reliable way.
Items provided in the package:
- Test cassette
- Capillary tube
- Sample buffer
- Test instruction
Principle - Cirrus SARS-CoV-2 IgM/IgG rapid test is an antibody-capture immunochromatographic assay for the simultaneous detection and differentiation of IgM & IgG antibodies to COVID-19 virus in human serum, plasma, and/or whole blood samples.
Country of Origin: Turkey
FDA Status: Under Listing FDA
Quantity of tests/ units per kit: 20
Face Masks (EXCEPT N95 RESPIRATOR) for general public/ healthcare personnel per IIE guidance.
Country of Origin: China
CE IVD - FDA Status: Listed
Quantity of tests/ units per kit: 20
Gowns Surgical
Country of Origin: Turkey
CE IVD - FDA Status: NA
Quantity of tests/ units per kit: 20
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