COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2440

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Specimen

Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Parainfluenza Virus Type 2, Parainfluenza Virus Type 3

Lineages detected

A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV) and Adenovirus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/ Influenza/ RSV/Adenovirus infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV and Adenovirus antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B/RSV/Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B ,RSV and Adenovirus. The SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test is intended for use by trained clinical laboratory personne

Assay Type

Immuno-Antigen

Reader Required

No

Subcategory

Validity test kit

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

LOD

100 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.031 AU ((Adenovirus))

False positives

0.036 AU ((SARS-CoV-2),)

False positives

0.057 AU ((RSV),)

False positives

0.071 AU ((Influenza B),)

False positives

0.05 AU ((Influenza A),)

False negatives

0.009 AU ((Influenza A),)

False negatives

0.014 AU ((Adenovirus))

False negatives

0.038 AU ((RSV),)

False negatives

0.009 AU ((Influenza B),)

False negatives

0.008 AU ((SARS-CoV-2),)

Precision

Evaluated

Accuracy

95.9 % ((Antigen RSV),)

Accuracy

98.4 % ((Antigen Influenza A),)

Accuracy

98 % ((Antigen SARS-CoV-2),)

Accuracy

98.4 % ((Antigen Adenovirus))

Accuracy

98.1 % ((Antigen Influenza B),)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.4 % ((Antigen SARS-CoV-2),)

Clinical Sensitivity

95 % ((Antigen Influenza A),)

Clinical Sensitivity

92.9 % ((Antigen Influenza B),)

Clinical Sensitivity

94.3 % ((Antigen RSV),)

Clinical Sensitivity

96.9 % ((Antigen Adenovirus))

Clinical Specificity

99.2 % ((Antigen SARS-CoV-2),)

Clinical Specificity

99.1 % ((Antigen Influenza A),)

Clinical Specificity

99.1 % ((Antigen Influenza B),)

Clinical Specificity

96.2 % ((Antigen RSV),)

Clinical Specificity

98.6 % ((Antigen Adenovirus))