0.3KG Throat Swab Coronavirus Test Kit Clinical Performance

COVID-19 Antigen Rapid Test Kit Clinical Performance of Antigen Test for fresh swabs

PERFORMANCE CHARACTERCS

The assay demonstrated excellent clinical specificity 100% (95% CI: 98.12%-100%). Overall Agreement was 96.21% (93.34%-97.87%).

1. Clinical Performance of Antigen Test for fresh swabs

Using 127 fresh NP swabs which were collected freshly in Extraction Buffer in the kit to evaluate the Clinical performance of the COVID-19 Antigen Rapid Test Kit. 67 Patients who presented within 7 days of symptom onset and 60 normal persons were included in the initial primary evaluation. The Result is below:

The assay demonstrated acceptable clinical sensitivity for fresh swab samples is 95.52% (95% CI: 87.64%-98.47%) when compared to a molecular device produced by Sansure Inc. The assay demonstrated excellent clinical specificity 100% (95% CI: 93.98%-100%). Overall Agreement was 97.64% (93.28%-99.19%).

2. 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%).

4. 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.

5. 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.

6. 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(308TCID ₅₀/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