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