The product has passed the NMPA(China National Medical Products Administraction) authority certification.
|Product||IgM/IgG Antibody Test Kit||Storage Temperature||2~30ºC|
|Package||Carton Package||Shelf Life||18 months|
|Package Spec.||20 tests/kit||Package Size||31*19.5*42.5cm|
|Lead Time||3~5 working days||Port||Shenzhen|
[Product Name] IgM/IgG Antibody Test Kit
This kit applies the principle of GICA to qualitatively detect the IgM and IgG antibody in human serum, plasma or whole blood. Take the test specimen and add it to the specimen well of the test paper, and then add 2 drops of specimen diluent. The IgM/IgG antibody in the specimen binds to the colloidal gold-labeled recombined antigen on the binding pad to form a complex, which diffuses forward along the nitrocellulose membrane (NC membrane) under chromatography. Then, it binds to an anti-human IgM/IgG antibody fixed on the NC membrane test line (M/G line) to form a purple-red band, showing the IgM/IgG antibody. The deeper the color of the band on the M/G line, the higher the concentration of the IgM/IgG antibody in the specimen will be. To monitor the effectiveness of the test card, a quality control line (C line) is set. Regardless of whether there is a M/G line, the C line shall show color development, or the test result will be judged as invalid.
For in vitro diagnostic use only. For professional use only
|Intended for use||This kit is used for the qualitative detection of SARS-C0V-2 IgM/IgG antibody in human serum, plasma or whole blood (include finger) in vitro.|
|Secimens Type||human serum, plasma and whole blood|
|Components||IgM/IgG Antibody test strip, Specimen diluent(3.0ml/kit)|
|Clinical performance||sensitivity : 93.06%|
|specificity : 98.25%|
|accuracy : 94.35%|
|Package Spec.||20 tests/kit(10 kits/case)|
By multiplex PCR-fluorescent probe technology, combined with fast one-step RT-PCR technology, the kit uses ORF1ab and the specific conserved sequence of nucleocapsid protein N gene as target regions. With the designed dual-target gene detection primer probe, the kit works with a high-efficiency RT-PCR reaction system for detection. After the end of the reaction, the results will be determined through analysis of the cycle threshold (Ct) of each channel. Moreover, the kit is designed with human housekeeping gene RNaseP for monitoring sampling, extraction,specimen addition, amplification and other related processes as an internal standard to effectively prevent false positive and false negative results, so as to ensure the specificity and accuracy of the test results.
[Storage Conditions and Validity]
The kit shall be stored at 4~30ºC and is valid for 12 months. After unpacking the aluminum foil bag, please use it as soon as possible.
1. It is suitable for specimens of human serum, plasma and whole blood; EDTA, heparin sodium and sodium citrate anticoagulant are recommended for plasma/whole blood.
2. Specimens shall be used as soon as possible after collection; if not used immediately, serum/plasma specimens can be stored at 2-8°C for 5 days; if long-term storage is required, they shall be stored at -20°C; and whole blood specimens shall be stored at 2-8°C to avoid hemolysis.
3. Do not use the specimen that contains a large amount of lipids, or any hemolytic or turbid, or the result determination may be affected.
Please read the Instructions for the kit carefully before use.
1. Take the test specimen and required reagents out of the storage environment and equilibrate them to room temperature;
2. Unpack the aluminum foil bag, take out the test card, and place it on a horizontal table;
3. 10μL serum,plasma samples or 15μL whole blood samples, add it vertically to the specimen well of the test card, and immediately add 2 drops (about 60μL) or add 60μL of specimen diluent with a pipette;
4. Start timing, and determine the result within 15min.
[Limitations of the Test Method]
The test resultshall be determined within 15min after the specimenis added, or the result will be invalid.
[Interpretation of Test Results]
1. This kit is intended for in vitro diagnosis use only.
2.Before use, please equilibrate the specimens and related reagents at room temperature. To prevent the test card from being affected with damp, please use it within 30min after unpacked.
3.Do not use any specimen diluent not matched with this reagent.
4. When adding the specimen with a dropper, discard the first dropor two drops of the specimensolution, and then add the specimen vertically to avoid air bubbles at thespecimen adding end.