COVID-19 test kit SOBC-CoVAb

for antibodiesIgGIgM

Intended Use The Novel Coronavirus (SARS-CoV-2) antibody (IgM/IgG) test is an in vitro diagnostic device that utilizes immunochromatography for the qualitative detection of Novel Coronavirus IgM/IgG antibody in a serum, plasma or whole blood specimen. This test complements the diagnosis of patients with suspected SARS-CoV-2 infection where by the nucleic acid test shows a negative result. It could be also used in conjunction with nucleic acid test to diagnose patients with suspected infection. Results from the Novel Coronavirus (SARS-CoV2) antibody (IgM/IgG) test should not be used as the sole basis for diagnosis, nor for exclusion. It is not used for screening of general population. The test is in cassette format and intended for professional Medical Institutions use only. Positive results require further confirmation while negative results do not preclude SARS-CoV-2 infection. This product is limited to clinical utilization and stored for emergency situation since December 2019. It is forbidden to use this product as routine clinical IVD reagents. Results from this product is for clinical reference only, and further analysis is suggested according to both the clinical symptoms of the patients and the results from the other laboratories. In the process of using this product, biohazard precautions should be taken according to the guidance or regulations of the specific countries. Certifications 1. CE 2. NMPA Characteristics 1. One-step in vitro test 2. Fast visually read result in 10~15mins 3. serum, plasma or whole blood specimen 4. Easy and fast operation 5. 4~30℃ storage 6. OEM is acceptable You're warmly welcomed to contact us if any queries or questions.