SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold Method)
For professional use.
The SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold Immunochromatographic Assay) is used for in vitro qualitative diagnostic of SARS-Co V-2 IgG/IgM in human serum, plasma, or whole blood specimen. lt is intended for use of screening tests and aid in the diagnosis of SARS-CoV-2 viral infections.
Our rapid test reliably detects the known SARS-CoV-2 mutations VOC-202012/01 (or B.1.1.7, N501Y.V1, or UK variant), N501Y.V2 (or B.1.351 or South African variant), and the Indian “double mutation” variant B.1.617. Please refer to the product manual or contact us for further information.
The SARS-CoV-2 IgG/IgM Rapid Test Cassette is only used as a supplementary detection indicator for suspected nucleic acid negative results or in conjunction with nucleic acid detection in the diagnosis of suspected cases. lt cannot be used as a basis for the diagnosis and exclusion of SARS-CoV-2.
A positive test result requires further confirmation. A negative test result does not rule out the possibility of infection.
The test results of this kit are for clinical reference only. lt is recommended to conduct a comprehensive analysis of the condition based on the patient’s clinical manifestations and other laboratory tests. Laboratory testing of 2019-nCoV should meet the requirements of the “Technical Guidelines for Covid-19 Laboratory Testing” to do a better biosafety job.
Components
- Test kits
- Test cassette
- Dropper
- Bottle of diluent
- Package insert
Features
- Sample: Serum, plasma, whole blood.
- 15 minutes to get results.
- Less sample, only 1 drop of sample is needed.
- Easy to collect samples, reduce the infection rate.
- No special requirement for lab technicians, labs, and hospitals.
- One cassette is for IgG/IgM, save cost, and test time.
Clinical Performance
- Test size: 260 samples
IgG
- Sensitivity: 92.13% (95% confidence interval: 86.11% – 95.67%）
- Specificity: 95.49% (95% confidence interval: 90.51% – 97.92%）
- Accuracy: 93.85% (95% confidence interval: 86.45% – 93.95%）
IgM
- Sensitivity: 85.71% (95% confidence interval: 77.76% – 91.15%）
- Specificity: 95.20% (95% confidence interval: 89.92% – 97.78%）
- Accuracy: 90.87% (95% confidence interval: 86.45% – 93.95%）
For further details, please refer to the product manual.
Certifications
- Our product is CE-IVD-certified.
- It has been accepted to the List of In Vitro Diagnostic Medical Devices for COVID-19 of the EU Commission’s Joint Research Centre.
Packaging Unit
- Box with 20 test kits plus accessories
