Clungene Covid-19 antigenic rapid test kit on professional rhino-pharyngeal swab results in 15 minutes

Rapid antigen COVID-19 CLUNGENE test on rhino-pharyngeal swab.

Caution:
The Customer expressly declares, with the order confirmation, to be aware that this product is classified as an In Vitro Diagnostic Device (IVD) intended exclusively for professional use, and therefore declares, under its own responsibility and aware of the civil and criminal consequences arising from untrue statements, to be a healthcare operator authorized to use the tests or that the diagnostic device purchased will be used exclusively by healthcare personnel authorized and appointed in the field of health surveillance.
Aware of the penal sanctions referred to in art. 76 of Presidential Decree 28/12/00 n. 445 in the event of false declarations and the forfeiture of any benefits resulting from the provision issued on the basis of untrue declarations, pursuant to art. 75 of the Presidential Decree of 28/12/00 n. 445; pursuant to and for the purposes of art. 47 of the aforementioned Presidential Decree 445/2000; as of now, the customer releases RAM Apparecchi Medicali srl from any civil, criminal or administrative liability.

The CLUNGENE COVID-19 Antigen Test is a lateral flow immunoassay method for the qualitative detection of SARS CoV-2 nucleocapsid antigen in nasopharyngeal and oropharyngeal swabs of individuals suspected of being infected with COVID-19.
The results are for the detection of SARS nucleocapsid CoV-2 antigen.
The antigen is generally detectable in nasopharyngeal swabs and oropharyngeal swabs during the acute phase of infection.
Positive results indicate the presence of viral antigen, but clinical relevance to the patient's medical history and other diagnostic information is required to determine the status of the infection. Positive results do not rule out the possibility of bacterial infection or co-infection with other viruses. The pathogen identified may not be the only cause of the disease. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for patient management or treatment decisions, including infection control decisions. Negative results should be considered based on the patient's recent exposure history, medical history, and the presence of clinical signs and symptoms in accordance with COVID-19 and, if applicable, confirmed by a patient management molecular test .
The new corona viruses (SARS-CoV-2) belong to the ß genus. COVID-19 is an acute infectious disease of the airways that affects humans. Currently, patients infected with the new coronavirus are the main source of infection. Even asymptomatic people can be a source of infection. According to current epidemiological studies, the incubation period is 1 to 14 days, usually 3 to 7 days. The main manifestations are fever, fatigue and dry cough. In some cases, nasal obstruction, runny nose, sore throat, myalgia, and diarrhea occur
 Rapid detection of COVID-19 antigens is based on a lateral flow immunoassay using the principle of double antibody sandwich technology. The monoclonal antibody SARS-CoV-2 nucleocapsid antibody conjugated to colored microparticles is used as a detector and sprayed on the conjugation plate. During testing, the SARS-CoV-2 antigen in the sample interacts with the conjugated SARS-CoV-2 antibody to stain the microparticles to form an antigen-labeled antigen-antibody complex.
This complex migrates by capillary action on the membrane to the test line where it is captured by the SARS-CoV-2 pre-coated nucleocapsid protein monoclonal antibody.

A colored test line (T) would be visible in the result window if SARS-CoV-2 antigens were present in the sample.
Absence of the T line indicates a negative result. The control line (C) is used as a procedural control and should always be displayed when the test procedure is performed correctly.

Package contents:
- 1 cassette with desiccant in a single sachet.
- 1 ReagentE.
- 1 sterilized swab (disposable swabs for specimen collection).
- 1 extraction tube.
- 1 tip.