COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1823

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated

Physical Support

Cassette, Lateral flow

Target type

Antigen

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

1. Product Information Product Name COVID-19 Ag Test Trade Name Rapidigen Product Code PHRPD 2020 Manufacturer Pharmaline Saglik Hizmetleri Ticaret A.S. Address Headquarter: Atatürk Caddesi, Atatürk Caddesi Konutlari, No: 43 A Blok Daire 6 Sahrayicedit-Kadiköy, 34734 Istanbul, Turkey. Factory: Bati Sitesi Mah. 2308 Cad. Gersan Sit. No.: 52, Yenimahalle, Ankara, Turkey. 2. Product Description Single-use cassette test for professional in vitro diagnostic usage. 3. Classification according to 98/79/EC In-vitro Diagnostic Medical Devices Professional Use IVD, 98/79/EC. 4. Intended Use Rapidigen COVID-19 Ag Test is used for in vitro qualitative detection of novel coronavirus antigen in human throat swabs or nasal swabs. 5. Sample Type Human throat or nasal swab. 6. Reagents This test included 2019- nCoV antibody, anti-chicken IgY polyclonal antibody, chicken IgY and colloidal gold conjugate. 7. Analysis Method Rapidigen COVID-19 Ag Test is a rapid, qualitative, immunochromatographic assay for detecting the 2019-nCoV antigen in human oropharyngeal or nasopharyngeal swabs. The sample will be under the capillary action to move forward along the test cassette when it contains a new antigen crown at a detectable level. The antigens with colloidal gold labeling are coronavirus monoclonal antigens—the complex immune fixes on the membrane. If the coronavirus monoclonal antibody forms the colored line, the visualization is positive for the coronavirus antigen; If the line does not show color, the result is negative. A colored line will always appear in the control line region, indicating that the proper specimen volume has been added and membrane wicking has occurred. 8. Performance Evaluation Rapidigen COVID-19 Ag Test has been evaluated using clinical samples. PCR methods are used to compare Rapidigen COVID- 19 Ag Test, and the following results are obtained.   8.1. Sensitivity & Specificity Rapidigen COVID - 19 Ag Test PCR Test Total Positive Negative Positive 164 3 167 Negative 12 438 450 Total 176 441 617 Analysis of coincidence rate of Rapidigen COVID-19 Ag Test and PCR Test in nasal samples: Sensitivity: 164/ (164+12) × 100% = 93.18% Specificity: 438 / (3+438) × 100% = 99.32% Accuracy: (164+438) / (164+12+3+438) × 100% = 97.57% 8.2. Interferences Samples containing Mucin, Hemoglobin, Histamine Hydrochloride, Human albumin, α- interferon, Lopinavir, Tobramycin, Ribavirin, Tramadol, Azithromycin, Meropenem, Oseltamivir, Benzocaine, Peramivir in different concentrations do not affect the test result. Test results present no interference. 8.3. Cross-Reactivity This product does not cross-react with pathogens of HKU1, OC43, NL63, 229E, MERS Coronavirus, Human Metapneumovirus, Influenza A virus H1N1, Influenza A virus H3N2, Influenza A virus H5N1, Influenza A virus H7N9, Influenza B virus, Mycoplasma pneumonia, Rhinovirus A, Rhinovirus B, Rhinovirus C, Staphylococcus aureus, Adenovirus 1, Adenovirus 2, Adenovirus 3, Adenovirus 4, Adenovirus 5, Adenovirus 7, Adenovirus 55, Enterovirus A, Enterovirus B, Enterovirus C, Enterovirus D, EB Virus, Measles virus, Human cytomegalovirus, Rotavirus, Norovirus, Mumps virus, Varicella-zoster virus, Respiratory syncytial virus, Mycoplasma pneumonia, and Escherichia Coli. 9. Packaging Consumer package includes: a) Primary package: An aluminum pouch including test cassette and silica gel. b) Secondary package: Carton box including tests in aluminum pouches, sterile swab, sample extraction tube, extraction tube tips, extraction reagent (R), workstation and instructions for use sheet. Packing instructions, labeling and symbols are prepared according to the 98/79/EC in-vitro diagnostic medical device directive, harmonized standards. c) The transportation package is a carton package covered with strong nylon film to provide extra protection for the products during transportation and storage. 10. Kit components Test cassettes, sterile swab, sample extraction tube, extraction tube tips, extraction reagent (R), workstation and instructions for use. 11. Storage & Shelf Life Store at 4 - 30°C (39 - 86°F); maximum 24 months 12. Transportation Truck or aircraft freight. Transport conditions should be between 4-30°C (39 - 86°F).

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Subcategory

Visualisation system

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Detection Principle

Magnetic Electrochemical

LOD

30 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

Sample contamination or not following the IFU protocol

False negatives

Sample contamination or not following the IFU protocol

Precision

Evaluated

Accuracy

98 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

93 %

Clinical Specificity

99 %