Dakewe COVID-19 Antigen Rapid Test Kit Brochure
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Superior Quality, Excellent Service Lotus NL B. V. Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands. Shenzhen Dakewe Bio-engineering Co.,Ltd.

Intended Use COVID-19 Antigen Rapid Test Kit is an immunochromatographic assay test intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimen. COVID-19 IgM/IgG Rapid Test Kit is an immunochromatographic assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma, and whole blood. COVID-19 IgM/IgG Rapid Test Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2,...

SUPERIOR QUALITY, EXCELLENT SERVICE COVID-19 Antigen Rapid Test Kit Nasopharyngeal Specimen Preparation Twist off Insert the collection vial into the hole bottom of provided preparation plate. Twist off the top of extraction buffer vial. Add all of the extraction buffer into the collection vial. Collect a swab specimen following universal collection guidelines. Insert the swab into the collection vial, rotate and squeeze the swab10 times. Rotate and squeeze the vial several times from outside. Properly discard the swab. Screw the cap of the collection vial and shake the vial to mix the...

Performance Characteristics Limit of Detection (Analytical Sensitivity) The COVID-19 Antigen Rapid Test LoD for nasopharyngeal swab specimen was confirmed as 22.5 TCID50/ml. Analytic Specificity Results demonstrated that COVID-19 Antigen Rapid Test has no significant cross-reactivity with the seromarkers listed as follows: Potential Cross-Reactant Adenovirus Human parainfluenza virus 1 Human parainfluenza virus 2 Human parainfluenza virus 3 Human parainfluenza virus 4 Respiratory Syncytial Virus A Bordetella pertussis Chlamydia pneumoniae Haemophilus influenzae Legionella pnuemophila...

SUPERIOR QUALITY, EXCELLENT SERVICE Interference A study was performed demonstrate that sixteen (16) potentially interfering substances that may be found in the upper respiratory tract do not interfere with the detection of COVID-19 in BioSci® COVID-19 Antigen Rapid Test. Substance Active Ingredient Whole Blood (human) Sodium Chloride (i.e. NeilMed) Throat Lozenge Benzocaine, Menthol OTC Homeopathic Nasal Spray 1 Galphimia glauca, Sabadilla OTC Homeopathic Nasal Spray 2 Zincum gluconium (i.e. Zicam) OTC Homeopathic Nasal Spray 3 OTC Homeopathic Nasal Spray 4 Fluticasone Propionate Sore...

COVID-19 IgM/IgG Rapid Test Kit Test Procedures Human serum/plasma or whole blood Add 1 drop of specimen to the sample well. Add 2 drops of buffer to the sample well. Read the results in 10-15 minutes. Result Interpretation Positive NOTE: The color intensity in the test region will vary. Any faint colored line(s) in the test region(s) should be considered as positive. Performance Characteristics Analytical Sensitivity Results demonstrated that BioSci® COVID-19 IgM/IgG Rapid Test has no significant cross-reactivity with the seromarkers listed following: Influenza A virus, Influenza B virus,...

SUPERIOR QUALITY, EXCELLENT SERVICE Interference The following substances and conditions were found not to interfere with the test. List of potentially interfering compounds and concentrations tested are as follows: Chemical analytes Chemical analytes Human Anti-mouse Antibody (HAMA) Diagnostic Sensitivity and Specificity A clinical study using a total 609 blood samples was conducted. The results of the COVID-19 IgM/IgG Rapid Test were compared with clinical reference standard and refer to the results of nucleic acid detection test. The diagnostic sensitivity and specificity of the IgM and...

Superior Quality, Excellent Service Shenzhen Dakewe Bio-engineering Co.,Ltd. Room 702-703, Building No.1 Shenzhen Biomedicine Innovations Industrial Park, No.14 Jinhui Road, Kengzi Street, Pingshan District, Shenzhen, China Telephone: (86-755) 86235300 E-mail: chen_lan@dakewe.net RD@dakewe.com Website: www.dakewe.com