SARS-CoV-2 (N)protein Antigen rychlotest (FluorescenČnÍ Immunochromatografie)
LOMINA SUPERBIO, a. s.
Praha 5, 158 00
BASIC DESCRIPTION OF THE PRODUCT
IVD test for the detection of SARS-CoV-2 Nucleocapsid Protein Antigen presence in a human oropharyngeal swab sample / ie the demonstration possible COVID19 infection.
The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human throat swab samples in vitro. It is only used as a supplementary detection indicator for suspected cases of new coronavirus negative nucleic acid detection or used in conjunction with nucleic acid detection in the diagnosis of suspected cases.
Classification of the medical device
medical device In vitro diagnostic medical device
Classification IVD Other according to EC Directive 98/79/EC Annex III
Indications and medical conditions
Demonstration of positivity for SARS-CoV-2 Nucleocapsid Protein Antigen in a human ORL swab thus a suspicion for COVID19 positivity.
- Testing strip in a plastic cassette
- Sterile swab
- A bottle with reagent/preservation solution
- UV emitter
- A dropper (1drop = 20ul)
- An IFU
- An MC calibration magnetic card if used with LSLC-20 Fluorescence Immunoassay Chromatography Analyzer
50 pieces test package composed of:
- Box A – 50 packages containing IVD tests and accessories.
- Box B – 50 bottles with liquid reagent/preservation
The kit is intended for use by healthcare professionals only.
Coronavirus (Coronavirus, CoV) is a single-stranded positive-stranded RNA virus with membrane. It belongs to Capsuloviruses, Coronaviridae, Coronavirus, and is the largest RNA virus known currently. According to the phylogenetic tree, the coronavirus can be divided into four genera: α, β, γ, and δ. Among them, the β coronavirus can be divided into four independent subgroups A, B, C, and D again. So far, in addition to the new coronavirus that caused an outbreak of viral pneumonia in Wuhan, a total of six coronaviruses (HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, and MERS-CoV) which can infect people were found. HCoV-229E and HCoV-NL63 belong to α coronavirus. HCoV-OC43, SARS-CoV, HCoV-HKU1 and MERS-CoV are β coronaviruses. Among them, HCoV-OC43 and HCoV-HKU1 belong to the A subgroup and SARS -CoV belongs to subgroup B, and MERS-CoV belongs to subgroup C
The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human throat swab samples in vitro. It is only used as a supplementary detection indicator for suspected cases of new coronavirus negative nucleic acid detection or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonitis infected by new coronavirus, and is not suitable for screenings in the general population.
The murine anti-SARS-CoV-2 N protein antibody is applied to the nitrocellulose membrane as a test strip (T), and the goat anti-rabbit secondary antibody is applied to the nitrocellulose membrane to form a quality control strip (C). Another mouse anti-SARS-CoV-2 N monoclonal antibody labelled with latex nano-fluorescent microspheres and rabbit IgG labelled with latex fluorescent microspheres is mixed and applied to a glass cellulose membrane to prepare a labelling pad. One end of the nitrocellulose membrane near the quality control line is provided with a fluid absorption pad and the other end near the test line is provided with the aforementioned marking pad. The test sample is dripped onto a labelling pad and the antigen will react with the applied marker and perform a chromatographic reaction due to the capillary effect in the nitrocellulose.
membrane and by a chemical reaction at the site of the test strip (T) and the quality control strip (C). When the test result is valid, the quality control strip shows a certain light intensity after illumination with the UV emitter. The bar (T) in the same way indicates the presence of N Protein Antigen if the test sample is positive.
The product BOX A (dry components) must be stored at temperatures 4-30° C.
The product BOX B (liquid components) must be stored at temperatures 2-10° C. It can shortly be exposed to 4-30 for a maximum of 10 days.
It must be protected from light.
The expiration dates, along with the batch serial number, are listed on the inner protective package of the test, on the reagent bottle and on the outer side of each box.
specificity / sensitivity