The Kit comes complete for the test!
It does not require additional equipment.
- COVID-19 IgG / IgM Test device
- Test Diluent
- Instruction for use
- Capillary tube 10 µl
- Box of 25 test kits
- Validity: 6 months
- Storage: 1-30 ° C
SEPL is in partnership with the Korean Humasis. Humasis Co. Ltd., engages in developing rapid test kits and point-of-care testing instruments. The company was founded on June 12, 2000 and is headquartered in Anyang, South Korea.
The Humasis COVID-19 LgG / LgM Test is one step in-vitro diagnostic test based on an immunochromatographic assay. It is designed for qualitative detection of Immunoglobulin G and Immunoglobulin M antibody of Novel Coronavirus (COVID-19) in human blood. An immunochromatographic test kit that aims to perform preliminary screening of COVID-19 in less time and cost, detecting IgG and IgM antibodies to COVID-19.
Detection of COVID-19 IgM antibodies tends to indicate a recent immune response to COVID-19, whereas detections of COVID-19 IgG antibodies indicate a later stage of infection of coronavirus disease.
Thus this Humasis COVID-19 IgG / IgM Test Kit is a combined test for these antibodies and can provide information on the stage of infection, from asymptomatic cases to the convalescence phase.
Humasis COVID-19 In Vitro Diagnostics Device is suitable for obtaining a fast result, ideal for situations in which the health professional needs to make decisions and act quickly, in addition to being useful for identifying patients who obtained false-negative results in PCR (reverse transcription polymerase chain reaction).
Humasis COVID-19 IgG / IgM Test was evaluated in a clinical study carried out at the Sun Yat-sen University Hospital for the validation of sensitivity and specificity. The test showed high clinical sensitivity above 90% on average, for a positive time for more than 4 days. Clinical specificity showed 100% for negative patients.
The patient has no specific lgM or lgG for SARS-CoV-2, indicating that he has not been infected or is at an early stage of infection and has not yet developed antibodies. Redo the test in a few days, taking into account the clinical condition.
IgM positive and IgG negative: Indicates recent immune response, infection 7 days or less.
IgM and IgG positive: Indicates specific immune response, infection for at least 7 days.
IgG positive and IgG negative: Indicates disease in convalescent phase or possible immunization of the patient. It must be evaluated with the clinical picture.
The test did not work correctly and needs to be redone.
Positive results should be considered in conjunction with the clinical history and other available data.
The biosensor strip designed to detect the presence or absence of an antigen antibody in a given sample.
These antibodies are combined to each other, once the sample inserted into strip it will plug to a chemical..
Y-shaped molecules are in response to exposure to antigens and each antibody is capable of binding only to a specific antigen.
So that reaction causes the formation of the coloured lines in test area