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COVID-19 Rapid Antigen and Antibody Tests - Saliva, Nasal and Nasopharyngeal
COVID-19 Rapid Antigen and Antibody Tests - Saliva, Nasal and Nasopharyngeal

MP Biomedicals Rapid SARS-CoV-2 Antigen Test - Box of 20 Tests (CE-IVD Certified)

by MP Bio
€ 160.00
Size

For volume/discounted pricing and EU orders please contact us at info@mybio.ie

The Rapid SARS-CoV-2 Antigen Test is a rapid, chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens present on human nasal, nasopharyngeal or oropharyngeal swab specimens.

EASY TO USE: Easy sampling using nasal, nasopharyngeal or oropharyngeal swab specimens.

RAPID AND CONVENIENT: Results in 15 minutes. Requires no instruments.

EXCELLENT PERFORMANCE CHARACTERISTICS: 

  • Specificity: 99.14% (nasopharyngeal), 99.20% (oropharyngeal), 99.20% (nasal)
  • Sensitivity: 96.08% (nasopharyngeal), 96.23% (oropharyngeal), 96.19% (nasal)
  • Accuracy: 98.59% (nasopharyngeal), 97.84% (oropharyngeal), 97.83% (nasal)

This product is CE-IVD marked for professional use and complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC).

INTENDED USE

Rapid SARS-CoV-2 Antigen Test is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Rapid SARS-CoV2 Antigen Test Card cannot be used as the sole basis to diagnose or exclude SARS-CoV-2 infection. Rapid SARS-CoV-2 Antigen Test Card detects the SARS-CoV-2 nucleocapsid protein (N protein). Theoretically, genetic SARSCoV-2 variants with non-nucleocapsid protein mutations do not affect the product performance.

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, patients infected by the novel coronavirus are the main source of infection, Asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

 

MATERIALS PROVIDED 

 CONTENTS FOR 1 TEST/BOX FOR 5 TESTS/BOX FOR 20 TESTS/BOX
SARS-CoV-2 Antigen Test Card (sealed in foil pouch) 1 5 20
Sterile Swab 1 5 20
Extraction Tube 1 5 20
Extraction Buffer 1 5 20
Instructions for Use 1 1 1
Tube Holder / 1 1


MATERIALS REQUIRED BUT NOT SUPPLIED

Clock or timer, biohazard waste container, personal protection equipment

 

DOCUMENTS:

SARS-CoV-2 AG flyer_07AG6020B