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COVID-19 Antigen Rapid Test Kit NASAL MEDICAL

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COVID-19 Antigen Rapid Test Kit NASAL MEDICAL

NKDCMNS25

COMPONENTS:

  • 25 x Sterile nasal swabs
  • 25x Sample lysis tube
  • 25 x test cassettes
  • 1 x Test tube rack
  • 1x Product Manual

The rapid antigen test consists of a rapid in vitro diagnostic test for the qualitative detection of an antigen (Ag) of the SARS-CoV-2 virus nucleocapsid in nasal samples obtained with a swab.

This test is intended for people who meet the clinical and / or epidemiological criteria of COVID-19. Target population: the entire population. The clinical study included symptomatic and asymptomatic, men and women of different ages.

These products are intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. They can be used in any environment, both in the laboratory and outside the laboratory, as long as they meet the requirements specified in the Instructions for Use and current regulations.

These tests are based on the antigen-antibody reaction where the presence of virus protein (nucleocapsid) is detected by the lateral flow immunochromatography technique. These are qualitative tests that offer only a positive or negative result, but that allow us to know the presence of SARS-COV2 infection in less than 15 minutes.

The test provides preliminary analysis results. Negative results do not rule out SARS-CoV-2 infection and cannot be used as the basis for treatment or other management decisions. Negative results should be combined with clinical observations, patient history and epidemiological information.

The use of these tests in the society will make possible a massive screening and detect people at the beginning of the infection, when it still has no symptoms and to prevent infection.

Nasal swab sampling is less invasive (and less annoying) and allows patients to collect the sample themselves under the supervision of health care personnel. This reduces physical contact, and therefore the risk of infection. The swab sample is placed in a tube containing a virus buffer. Three drops from this sample are dropped onto a cassette. As the sample moves through the device, the SARS-CoV-2 nucleocapsid proteins, that are present in the sample, and the control proteins will be captured by the antibodies at the test and control lines, respectively. This capture and join process produces a color change along the test and control lines that can be seen with the naked eye, producing one or two lines depending on a positive or negative result.

Type of sample: Nasal

Test time: <15 minutes

It does not require additional tools, it can be done in a wide variety of environments

Includes sample rack

Pre-dosed lysis tube (offers ease of use and speed)

Swab is broken and remains inside the tube (increased extraction time of sample and waste reduction)

Result Mareskit (TM) Antigen Rapid Test Vs. PCR:

  • Specificity: 100%
  • Sensitivity: >95%


Storage
: 4ºC-30ºC


Format
: 25 u/box

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