COVID-19 Rapid Diagnostic Throat Test Kits OEM 95.52% Sensitivity

ISO Rapid Diagnostic Throast Test Kits Certificated with CE Antigen Test for fresh swabs COVID-19 Antigen China OEM

PERFORMANCE CHARACTERCS

The assay demonstrated excellent clinical specificity 100% (95% CI: 93.98%-100%). Overall Agreement was 97.64% (93.28%-99.19%). The assay demonstrated acceptable total clinical sensitivity is 91.08% (95% CI: 85.59%-94.61%) when compared to a molecular device produced by Sansure Inc. The assay demonstrated excellent clinical specificity 100% (95% CI: 98.54%-100%). Overall Agreement was 96.64% (94.44%-97.99%).

Overall Clinical Performance of Antigen Test Kit

A total of above 157 positive samples and 260 negative samples were detected to evaluate the clinical performance of the COVID-19 Antigen Rapid Test Kit. The Result is below:

The assay demonstrated acceptable total clinical sensitivity is 91.08% (95% CI: 85.59%-94.61%) when compared to a molecular device produced by Sansure Inc. The assay demonstrated excellent clinical specificity 100% (95% CI: 98.54%-100%). Overall Agreement was 96.64% (94.44%-97.99%).

Limit of Detection(LoD)

Limit of detection (LoD) was determined by evaluating different concentrations of heat inactivated SARS-CoV-2 virus. LoD of the SARS-CoV-2 antigen rapid kit was confirmed as 38.5 TCID₅₀/ml.

High-dose Hook effect

No high dose hook effect was observed when test with up to a concentration of 6.3×10⁵ TCID₅₀/ml of heat inactive SARS-CoV-2 virus from Academy of Military Sciences PLA China.

Cross Reactivity

Many types of pneumonia are companied by fever, cough and other respiratory symptoms. In order to eliminate similar clinical symptoms of other types of pneumonia effects, pneumonia mycoplasma, influenza A, pneumococcus etc. were detected for the specific assessment. Each of the organism and viruses were tested in the absence or presence of heat inactivated SARS-CoV-2 virus (308 TCID₅₀/ml), No cross-reactivity or interference was seen.

WUXI OWGELS MEDICAL INSTRUMENTS CO., LTD.

was established in 2001, is a hi-tech manufacturer of oxygen concentrator with 20 years manufacturing experience in China.

Main products are medical oxygen concentrators, respiratory therapy equipements and Covid-19 Antigen Rapid test kits with the CE, SGS, FDA and ISO certificates. Our products already received unanimous praise from hundreds of our clients at home and abroad.

With outbreak of the COVID-19 virus, to provide epidemic prevention and control supplies to our old clients, in 2020, we established two more factories to produce disposable medical masks and KN95 masks. Besides these products, we also provide detection reagents.

1. Oxygen concentrators
2. Covid 19 Antigen Rapid Test Kits

3. Oxygen atomizer
4. Disposable medical face mask

5. KN95 medical face mask