INNOVA SARS-CoV-2 Rapid Antigen Lateral Flow Qualitative Test Kit. Box of 25 kits.

SKU:
INTESTKIT
£120.00
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Technical Specification

Brand - INNOVA
Detailed Technical Information -

 

INNOVA SARS-CoV-2 Rapid Antigen Test characteristics

  • Assay format: Lateral flow test / immunochromatographic
  • Instrument: No
  • Testing time: 20-30 minutes
  • Specificity: 100%
  • Overall Acuuracy: 98.98% 
  • Antigen: N
  • Sample material: Nasal and/or throat swab

Performance Characteristics

  • The INNOVA SARS-CoV-2 Covid-19 Antigen Test (Swab) has been evaluated with specimens obtained from patients.
  • A commercialised molecular assay was used as the reference method.
  • The results show that the Innova Covid-19 Antigen Test (Swab) has a high overall relative accuracy.

Validation and Assessment

Tested by Public Health England & validated by the UK government

  • Rapid diagnosis of SARS-CoV-2 infections
  • Evaluated and Validated by the UK Government: 1 of only 3 tests for use by schools, hospitals, and the army. Used by the NHS in the UK. More details HERE.
  • This test is being rolled out by the UK government to mass test the population in Liverpool and other cities, See www.gov.uk for more information (test 1 on the list).
  • CE Marked: For professional use
  • ISO13485: Innova manufactures in accordance with their ISO13485 Quality Management accreditation. 
    • The Innova SARS-CoV-2 COVID Lateral Flow Rapid Antigen test kit facilitates the detection of COVID-19 with rapid return of results.

    • The Innova SARS-CoV-2 COVID Antigen Test has been tested by the UK Government. Click Here for details

    • This antigen test is intended for use by clinical professionals.

    The Rapid COVID-19 Innova Antigen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nose and/or throat swab from individuals who are suspected of COVID-19 by their healthcare provider.

    It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.

    The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. Currently, individuals infected by SARS-CoV-2 are the main source of transmission; asymptomatic carriers are also known as a source of transmission. Based on the current epidemiological information, the incubation period can last from 1 to 14 days, where the average time before symptoms occur is about 5 days. Symptoms include fever or chills, cough, shortness of breath, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, runny nose, nausea or vomiting and diarrhea.

    These rapid lateral flow tests generate accurate results, usually within 15 minutes. This Antigen test has 100% specificity, 98.98% overall accuracy.

    • Qualitative, visually read results in 15 minutes

    • No instrument required

    • Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)

    • Procedural internal control included

    • Sterile Swabs, Extraction Buffer and Extraction Tubes included

    • Dispose of used test components according to the IFU

    This item line is exempt from our usual returns policy. This item is non-returnable or exchangeable.

    Box Content:

    Each box contains everything to perform 25 tests, and comprises of:

    • Test device – individual foil wrapped with desiccant x 25 cassettes

    • Extraction buffer solution x 2 bottles

    • Sterile swabs x 25

    • Extration tubes x 25

    • Instructions for use and Quick Reference Guide

    Test Procedure:

    1a. Specimen Collection (Nasal Swab Collection)

    • Use the swab supplied in the kit

    • Carefully insert the swab into one nostril.

    • Swab tip should be inserted about 2.5 cm (1 inch).

    • Roll swab firmlyagainst thenostrilinside wallfirmly 5 times

    • Withdraw the swab from the nasal cavity.

    • Swab both nostrils

     

    1b. Specimen Collection (Throat Swab Collection)

    • Use the  swab supplied in the kit

    • Open your mouth wide and rub the fabric tip over both tonsils (or where they would have been)

    • Do this firmly 3 times

    • Roll swab firmlyagainst thenostrilinside wallfirmly 5 times

    • Carefully withdraw the swab from throat

    2. Sample preparation

    • Insert the test extraction tube into the workstation

    • Make sure that the tube is standing firm and reaches the bottom of the workstation

    • Add 0.3 mL (about 6 drops) of the sample extraction buffer into the extraction tube.

    • Insert the swab into the extraction tube which contains 0.3 mL of the extraction buffer. Roll the swab at least 10 seconds while pressing the head against the bottom and side of the extraction tube. Leave the swab in the extraction tube for 1 minute.

    • Squeeze the tube several times with fingers from outside of the to immerse the swab

    • Remove the swab. The extracted solution will be used as test sample.

    • Fit the cap tip with filter on top the extraction tube tightly

    3. Interpretation of Results

    • Allow the test device, test sample and buffer to equilibrate to room temperature prior to testing

    • Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

    • Ensure the nozzle with filter is fitted on to the sample extraction tube tightly.

    • Reverse the sample extraction tube, and add 2 drops ( of test sample by squeezing the extracted solution tube into the sample window.

    • Wait for the colored band(s) to appear. The result should be read in 20 minutes.

    • Do not interpret the result after 30 minutes.

    Test results:

    • POSITIVE - The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

    • NEGATIVE* - The presence of only control line (C) within the result window indicates a negative result.

    • INVALID - If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

    http://www.portableoxygen.co.uk/images/Innova_1a.png

    Note: The intensity of color in the test line region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. Please note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

    (*Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.)

    In-vitro use only. Please note, each box includes 1 x work station and 2x buffer solutions, therefore it can only be split in 2 packs of 10 test kits each.