COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2632

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Card

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Coronaviruses (HCoV)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

1.When the titer of the SARS-CoV-2 culture is 2.5×105TCID50/ml, the test result of this test card does not show a hook effect; when the concentration of the SARS-CoV-2 positive quality control product is within the range of 0.5mg/ml, the test result of this test card does not show a hook effect . 2.Nasopharyngeal swab specimens can be stored at 2℃-8℃ for at least 8h. 3.The loading volume of theSARS-CoV-2 antigen test strip is 50μl. 4.After opening the foil bag, the SARS-CoV-2 antigen test strip meets the requirements within 60 minutes. But the test result will fail after opening for 90 minutes. Therefore, the bag-opening stability is set at 60 minutes. 5.The general storage temperature of the kit is about 25°C. According to the Arrhenius formula, the logarithm of the expiration date and the reciprocal of the absolute temperature have a linear relationship. Accelerated at 37°C for 3 months (90 days), converted to approximately 12 months (360 days) stored at 25°C. Therefore, in the absence of real-time stability test results, it is temporarily assumed that the SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) is valid for 12 months.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

Yes

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Detection Principle

Colloidal gold

LOD

0.1 ng/mL

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

4 %

False negatives

1 %

Precision

Not evaluated

Accuracy

98 % ((Antigen))

Reproducibility

Not evaluated

Robustness

Evaluated

Clinical Sensitivity

96.04 % ((Antigen))

Clinical Specificity

99 % ((Antigen))

Type of antigen

Nucleocapsid protein