REAGEN  This kit is used for the qualitative detection of COVID-19 antibodies in human serum, plasma and whole blood samples in vitro. It is only used as a supplementary detection indicator for suspected cases of COVID-19 negative nucleic acid detection or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonitis caused by COVID-19 infection. It is not suitable for screening of the general population. Restricted to medical institutions. A positive test result requires further confirmation. A negative test result does not rule out the possibility of infection.

Mechanism Of Reaction

REAGEN  COVID-19 IgG/IgM detection reagent uses the principle of specific binding of antigens and antibodies and immunochromatographic techniques. The reagent contains an anti-human IgM monoclonal antibody fixed in the test area (C) on the test strip in advance. (M) and anti-human IgG monoclonal antibody (G) and goat anti-chicken IgY in the QC region and anti-COVID-19 IgM specific protein-conjugated colloidal gold (M.nC- GC gold label conjugate) and chicken IgY coupled colloidal gold. During the test, the specimen is dropped into the reagent sample well (S). The sample moves to the detection line by capillary chromatography. If there is an IgM antibody against COVID-19 in the sample, it will be combined with the M.nC-GC gold label conjugate to form an IgM-M.nC-GC complex. This complex continues to migrate forward under the action of chromatography and is captured by an anti-human IgM monoclonal antibody fixed to the M line in advance, forming a wine-red band, indicating that IgM is positive for COVID-19;if IgG antibody of COVID-19, under the action of capillary chromatography, also binds to M.nC-GC and is captured by the G line. It also forms a burgundy band, indicating that the IgG of COVID-19 is positive; if M and G does not show color, the sample is COVID-19 negative; and COVID-19 IgG/IgM detection reagent contains a built-in quality control line. Regardless of whether IgG/IgM is present in the specimen, a wine-red band will appear in the quality control area ( C). The burgundy band shown in the quality control area (C) is the criterion for judging whether there are enough samples and whether the chromatography process is smooth.

Kit Contents, Storage And Shelf Life

The REAGEN  COVID-19 lgG/lgM Rapid Test Kit has the capacity for 40 determinations. The shelf life is 12 months when the kit is properly stored.

Warnings And Precautions

• This product is a single-use in vitro diagnostic reagent. Do not reuse it. Do not use it if it is expired.

• The temperature of the experimental environment should be avoided. The test cards and sample dilutions stored at low temperature should be restored to room temperature before opening to avoid moisture absorption.
• Use fresh samples whenever possible, avoid using samples that are contaminated, hemolytic, jaundice or hyperlipidemia.
• After the test, treat the used test strips and sample dilutions as biomedical waste.
• The desiccant is contained in the packaging bag.
• Do not use freeze-thaw samples repeatedly. When testing, please equilibrate the sample to be tested to room temperature.
• The test samples should be regarded as infectious agents, and they must be operated in accordance with the infectious disease laboratory operation rules, and pay attention to biological safety operations.
• As with all diagnostic reagents, the final diagnosis should be made by the doctor after combining the various indicators and clinical symptoms.
• If you have any questions or suggestions during the use of this reagent, please contact the manufacturer.
• The kit should not be used in case of damaged packaging.
• Items in each area are for exclusive use, and should not be used crosswise to avoid pollution. Please clean the workbench immediately after the experiment. Please use the tip used in the experiment directly into the waste tank containing 1% sodium hypochlorite, and sterilize with other waste products before discarding. After removing the reaction tube after amplification, immediately seal it in a special plastic bag and discard it at the designated place. The workbench and various items are regularly disinfected with 1% sodium hypochlorite, 75% alcohol or UV lamps.

Sample Requirements

Serum/plasma/ whole blood

Serum / plasma sample collection: Serum and plasma should be separated as soon as possible after blood collection to avoid hemolysis. The separated serum and plasma should be tested as soon as possible within 8 hours. If it cannot be used in a timely manner, it should be stored at 2℃ to 8℃for 3 days. If it is more than 3 days, it should be stored at -20℃and stored for less 9 days, pay attention to return to room temperature before testing to avoid repeated freezing and thawing. Severe hemolytic and heat-inactivated samples are not recommended.

Whole blood collection: Use anticoagulation tube to collect blood, or add anticoagulant in the blood collection tube (recommended to use heparin, EDTA salt, sodium citrate for anticoagulation). It can be stored at room temperature for 8 hours. If it cannot be detected immediately, it can be stored at 2 ~ 8℃ for 3 days. Whole blood samples over 3 days are not suitable for this reagent.