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Freeze-dried Novel Coronavirus (COVID-19) Nucleic Detection Kit (Fluorescence PCR method)

INTENDED USE This kit is used to achieve qualitative detection of ORF1ab, N gene of 2019-nCOV viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of suspected infected patients suspected to have clustered cases and other patients requiring diagnosis. The kit is a fully premix lyophilized system, which includes materials needed for 2019-nCoV detection: reverse transcriptase, nucleic acid amplification enzyme, reaction buffer, specific primer and probe. RT-PCR detection can be carried out directly after adding the extracted sample RNA and and supplemented with water up to 25 μL. PRINCIPLE This product is a multiplex fluorescent probe-based Taqman® RT-PCR assay system. Specific primers and probes are designed for the detection of ORF1ab, N gene of 2019-nCoV respectively. An Internal control serves as the monitor to confirm successful extraction and identify possible PCR inhibition for the entire testing system to prevent false negative detection results

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SARS-CoV-2 Antigen Test Kit (colloidal gold method) 1 piece

INTENDED USE This kit is only used for the in vitro qualitative detection of SARS-CoV-2 antigen from human nasopharyngeal swabs. This kit is suitable for the auxiliary diagnosis of COVID-19, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests and treatment responses. Positive test result needs to be further confirmed, negative result does not preclude SARS-CoV-2 infection. This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.

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SARS-CoV-2 Antigen Test Kit (colloidal gold method)

TEST PRINCIPLE The kit is immunochromatographic and uses double-antibody sandwich method to detect SARS-CoV-2 antigen. During detection, the treated samples are loaded into the sample wells of the test card. When the concentration of SARS-CoV-2 antigen in specimen is higher than the minimum detection limit, the viral antigen will form complexes with labeled antibodies first. Under chromatography, the complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibody of SARS-CoV-2 in detection zone on nitrocellulose film (T) to form a pink/purple reaction line on the detection zone, at this point the result is positive; conversely, if there is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit, no pink/purple reaction line appears in the detection zone, at this point the result is negative. Regardless of whether the sample contains viral antigens or not, a pink/purple reaction line will appear in the quality control zone (C), the pink/purple reaction line that appears in the quality control zone (C) is the criterion for determining if the chromatography process is normal.

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Nucleic Acid Extraction kit

Intended Use For isolation and purification of high-quality viral DNA / RNA from serum, plasma, swab preservation solution or various virus preservation solutions. Only available for lab on IVD application.

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BIOTEKE CORPORATION (WUXI) CO., LTD.
4th Floor, D5, No.1719, Huishan Avenue, Wuxi - 214174, Jiangsu, China
Ms. Mary Evans (Global Electronic Commerce Operater)
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