COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2249

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cassette, Lateral flow

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasal swab

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), P.2 (Zeta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Validation of the Unibioscience SARS CoV-2 Antigen Rapid Nasal Test was performed in correlation with the respective Ct values of the positive PCR samples, including clinical data on the duration of disease symptoms. Validation tests of PCR samples from symptomatic individuals with symptom onset before 5 days (N=400) resulted in a sensitivity of 99.00% (95% CI: 97.46%-99.73%) with a mean Ct value of 26.17 (Min 17.2 - Max 39.4). From the validation tests of PCR samples with a Ct value < 30 (N=250), a mean Ct value of 22.30 (Min 17.20-Max 29.90) resulted in a sensitivity of 99.60% (95% CI: 97.79%-99.9%). From the validation tests of PCR samples with a Ct value ≥ 30 (N=150), a mean Ct value of 32.60 (Min 30.1-Max 39.4) resulted in a sensitivity of 98.00% (95% CI: 94.27%-99.59%) The PCR test used in the validations was real-time PCR. The EasyprepFast real-time PCR kit was used. SARS-Cov-2 was the target genome. The corresponding target gene was the N1 and the E gene with the following primers: SARS-CoV-2_IBS_N1 / SARS-CoV-2_IBS_E2For the internal positive control (IPC), a GAPDH primer set was used. FAM, HEX and Cy5 dyes were applied for staining.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Subcategory

Visualisation system

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

LOD

7.57 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.25 % (1/400)

False negatives

1 % (4/400)

Precision

Evaluated

Accuracy

99 ( (Antigen))

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

99 % ( (Antigen))

Clinical Specificity

99 % ( (Antigen))

Type of antigen

Nucleoprotein