COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2959

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cassette, Lateral flow

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein, spike protein

Specimen

Nasal swab

Cross-reactivity (pathogens tested)

Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mumps Virus (MuV), Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Rhinovirus A, Rhinovirus B

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), 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.1.526.1, 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

1) Intended use: Atlas COVID-19 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19. This test is designed for nasal swab samples in symptomatic individuals who are suspected of COVID-19. The COVID-19 Antigen Rapid Test (Nasal Swab) gives a preliminary result only. The final confirmation should be based on clinical diagnostic results. 2) Test Principle: The Atlas Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Nucleocapsid protein Antigens in swab specimens. SARS-CoV-2 Nucleocapsid protein antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 Nucleocapsid protein antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 Nucleocapsid protein antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred. 2) Performance and Specification: Atlas Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with \collected nasal swab specimen. The test is intended for use in symptomatic individuals meeting the case definition for COVID-19, and to test asymptomatic individuals limited to contacts of confirmed COVID-19 cases or probable cases and to at-risk health workers. Results are for the detection of COVID-19 Nucleocapsid protein 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 are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARSCoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. 3) Materials provided: • Atlas COVID-19 Antigen Rapid Test Cassette. • Sterilized swab. • Extraction tube. • Sample extraction buffer. • Instructions for use

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

Sample preparation

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Membrane-based

LOD

100 TCID50/ml (The LoD for Atlas COVID-19 Rapid Antigen Test (Nasal Swab) is 100 TCID50/ml of heat-inactivated virus, and 100pg/ml using a recombinant viral antigen.)

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

The reading of test after 20 minutes of sample application may lead false positive test result

False negatives

The using of open pouch after 2 hours from the opening time may lead false negative test result

Precision

Evaluated

Accuracy

98.4 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

97.8 %

Clinical Specificity

99 %

Type of antigen

Nucleocapsid protein