Rapid 2019-ncov coronavirus Antigen test

Short Description:

Used For 2019 coronavirus test
Specimen Nasal Swab or Saliva Swab
Certification CE/ISO13485/White List/Register in DE
MOQ 10000 test kits
Delivery time 1 week after Get payment
Packing 1 test kits/Packing box
Test Data Over 95% Sensitivity and Specificity
Shelf Life 2 years
Production Capacity 1 Million/Week
Payment T/T, Western Union, Paypal


Product Detail

Product Tags

The IMMUNOBIO Rapid coronavirus Antigen test kit is a Rapid detection method of COVID-19 antigen. Anti-2019-ncov monoclonal antibody was coated on a test line and conjugated with colloidal gold.During the test, the sample reacted with the anti-2019-ncov antibody conjugate in the test strip. The mixture then migrated up the membrane by capillary action and reacted with another anti-2019-ncov monoclonal antibody from the test area.

The IMMUNOBIO Antigen test kit is a rapid test for the qualitative detection of antigens to the novel coronavirus SARS-CoV-2 in human throat and nasal secretions. For professional in vitro diagnostic use only

PERFORMANCE CHARACTERISTICS

1. Sensitivity, Specificity and Accuracy The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

Method Gold standard reagent(PCR) Total Results
SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) Results Positive Negative
Positive 87 0 87
Negative 4 300 304
Total Result 60 300 391

 

Relative Sensitivity: 95.60% (95%CI: 88.89%~98.63%)

Relative Specificity: 100% (95%CI:98.78%~100.00%)

Accuracy: 98.98% (95%CI:97.30%~99.70%)

2. Limit of Detection (LOD)

The limit of detection of the SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) has been studied. The LOD of the test to the SARS-CoV-2 N protein is around 0.2-0.5ng/mL.The LOD of the test to the SARS-CoV-2 virus (inactivated) is about 2-5X102 TCID50/mL

Concentration Positive/Result Agreement Rate
0.5ng/mL N protein 100/100 100%
5X102 TCID50/mL 100/100 100%

3. Cross-reactivity:

The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is associated with a panel of proteins of other human coronavirus recombinant antigens and other respiratory symptoms relative virus. The results showed in below sheet:

Substance Concentration Result
SARS-CoV-2 N protein 0.001μg/mL positive
SARS-CoV N protein 1μg/mL negative
MERS-CoV N protein 1μg/mL negative
HCoV-NL63 N protein 1μg/mL negative
HCoV-229E N protein 1μg/mL negative
HCoV-HKU1 N protein 1μg/mL negative
Parainfluenza virus 1X105TCID50/mL negative
Influenza A virus 1X105TCID50/mL negative
Influenza B virus 1X105TCID50/mL negative
Chlamydia pneumoniae 1X105TCID50/mL negative
Adenovirus 1X105TCID50/mL negative
Mycoplasma pneumoniae 1X105TCID50/mL negative
Respiratory syncytial virus 1X105TCID50/mL negative

4.Interfering Substances:

The following compounds have been tested using the SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) and no interference was observed.

Substance

Concentration

Result

Alpha-interferon

3millionIU

No interference

Purified Mucin

1000ng/Ml

No interference

Authorized certifications

1. CE/ISO13485/White List

2. Registered in Germany Ministry of Health

Rapid-2019-ncov-coronavirus-Antigen-test

TEST PROCEDURE

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