Edinburgh Genetics ActivXpress+ COVID-19 complete antigens test set.

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Edinburgh Genetics ActivXpress+ COVID-19 complete antigens test set.

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£399.00


Product Information
Specification

Edinburgh Genetics ActivXpress+ COVID-19 complete antigens test set.

SARS-CoV-2 antigens test set, IVD, kit, immunochromatographic test (ICT), corona antigens rapid test.

 

Example use of the antigens test set.
Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Test Kit is intended for the qualitative detection of antigens from severe acute respiratory syndrome associated coronavirus 2 (SARS-CoV-2) in a clinical specimen.

Summary.
The novel coronaviruses belong to the β-genus. COVID-19 is an acute respiratory infectious disease. Currently, patients infected with the new coronavirus are the main source of infection; asymptomatically infected people may also be an infectious source. Based on current epidemiological studies, the incubation period is 1 to 14 days, usually 3 to 7 days. The main symptoms are fever, fatigue and dry cough. Nose congestion, runny nose, sore throat, myalgia and diarrhoea occur in some cases. Standard recommendations to prevent the spread of infections include regular hand washing, mouth and nose covering when coughing and sneezing. Avoid close contact with anyone showing symptoms of respiratory diseases such as coughing and sneezing.

Testing principle of the antigen test. 
Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Test Kit is a double antibody sandwich, high quality membrane based immunoassay in vitro diagnostic medical device. The kit is designed to detect nucleocapidide antigen of the SARS-CoV-2 in nasopharyngeal swab or oropharyngeal swab of patients suspected of being COVID-19-positive. The SARS-CoV-2 antigens present in the sample react with antibody-coated particles in the test cassette. The mixture then migrates upwards on the membrane by capillary action and reacts with the precoated antibody in the test line region. If the sample contains SARS-CoV-2 antigens, a coloured line appears in the test line region. If the sample does not contain SARS-CoV-2 antigens, no coloured line appears in the test line region, indicating a negative result. To serve as a procedural control, a coloured line always appears in the control line area, indicating that the correct volume of the specimen has been added and that membrane technique has been used.

Storage instructions.

  • Store the kit at room temperature or cool (2-30°C).
  • Do not freeze.
  • The sealant has a shelf life of 12 months.

Download of documents:
CE Declaration Edinburgh Genetics ActivXpress COVID-19 Antigen test kit
CFS Certificate Edinburgh Genetics ActivXpress COVID-19 Antigen test set
Edinburgh Genetics ActivXpress COVID-19 Antigen Complete Testing Kit v1.8
Edinburgh Genetics ActivXpress Antigen Complete Testing Kit
Edinburgh Genetics ActivXpress COVID-19 Antigen Complete Testing Kit v1.7

Continuous quality control.
Internal controls are included in the test. A coloured line appearing in the control area (C) confirms that the sample volume is sufficient and that the technique of the procedure is correct. Positive and negative controls, which are not included, can be used to confirm the test procedure and verify the proper functioning of the test.

Contents:

  • EGCV0101B: 20 x test cassette, 20 x sterilised nasopharyngeal wab, 20 x reagent in tube with dropper.

Larger quantities on request. If you would like to have antigens tested by professionals at your company on location, that is also possible. Please contact us for this. 

Also available on request:

  • EGCV0101: 1 x test cassette, 1 x sterilised nasopharyngeal cloth, 1 x reagent in tube with dropper.
  • EGCV0101A: 10 x test cassette, 10 x sterilised nasopharyngeal swab, 10 x reagent in tube with dropper.
  • EGCV0101M: 1 x test cassette, 1 x sterilized oropharyngeal cloth, 1 x reagent in tube with dropper.
  • EGCV0101MA: 10 x test cassette, 10 x sterilized oropharyngeal cloth, 10 x reagent in tube with dropper.
  • EGCV0101MB: 20 x test cassette, 20 x sterilized oropharyngeal cloth, 20 x reagent in tube with dropper.

One test cassette contains: a membrane strip coated with anti-SARS-CoV-2 monoclonal antibody on the test line and a colour path containing colloidal gold in combination with SARS-CoV-2 monoclonal antibody.
Materials not included, but required: Gloves and timer.

Performance characteristics.

  • When tested with 38 confirmed positive and 40 confirmed negative PCR samples, the tests show a sensitivity of 94.7% (36/38) and a specificity of 100% (40/s40).
  • The detection limit is 35 ng/mL (using recombinant SARS-CoV-2 nucleocapide protein).
  • The results show no cross-reactivity with human coronavirus 229E, human coronavirus OC43, human coronavirus HKU1, Influenza A (H1N1) and Influenza B, (Yamagata) and the Adenovirus, MERS, NL63, 229E, OC43, HAdV-1, HAdV-3, HAdV-5, HAdV-7, HAdV-8, HAdV-11, HAdV-18, HAdV-23, HPIV-1, HPIV-2, HPIV-3, HPIV-4, HRV-1, HRV-14, HRV-42, HMPV, RSV-A, RSV-B at 1x106 pfu/mL concentration.

Sampling requirements.
Specimens obtained early during the onset of symptoms will contain the highest viral titres. Samples obtained after 5 days of symptoms are more likely to have negative results compared to an RT-PCR test. Insufficient specimen, improper handling and/or transport may result in false negative results; therefore, specimen collection training is strongly recommended due to the importance of specimen quality to generate accurate test results.

Sample Collection.

Nasopharyngeal Swab Sample Collection:
Place a mini-tip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance from the ear to the patient's nostril indicates contact with the nasopharynx. The smear should reach a depth equal to the distance from the nostrils to the outer opening of the ear. Gently rub and roll up the smear. Leave the swab in place for a few seconds to absorb secretions. Remove the swab slowly as you rotate it around. Samples can be collected from both sides using the same swab, but it is not necessary to collect samples from both sides if the mini-tip is saturated with liquid from the first collection. If abnormal septum or clogging makes it difficult to obtain the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

Oropharyngeal swab sampling:
Insert a swab into the posterior pharynx and into the tonsillary regions. Rub the swab over the two almond pillars and the posterior oropharynx and avoid touching the tongue and teeth.

Sample preparation.

  1. Open the lid of the tube with the buffer solution.
  2. Insert the smear into the tube.
  3. Turn the cotton swab into the tube for one minute.
  4. Close the lid of the extraction tube with the cap until use.

Instructions for use.

  1. Allow the test, sample and/or reagent to reach room temperature (18-30°C) prior to testing.
  2. Remove the test cassette from the foil bag and use within one hour.
  3. Place the cassette on a clean and flat surface.
  4. Use a dropper to transfer 3 drops (approximately 100μL) of reagent from the specimen to the specimen well off the test cassette, then start the timer.
  5. Wait for the coloured line(s) to appear.
  6. Read the results after 15 minutes. Do not interpret the results after 20 minutes.

Sample transport and storage.
Freshly collected specimens should be prepared as soon as possible and no later than one hour after collection. Prepared specimens should not be stored at 2-8°C for more than 24 hours. If prolonged storage is necessary, store at -70°C and avoid repeated freezing/thaw cycles.

Results.

  • Negative result: One coloured line appears in the control line. No line appears in the test area.
  • Positive result: Two coloured lines appear. One coloured line appears in the control area and another adjacent line appears in the test area.
  • Invalid result: The control line does not appear. Insufficient specimen volume or incorrect procedure techniques are the most likely reasons. Review the procedure and repeat the test with a new test. If the problem persists, stop using the test kit immediately and contact your local distributor.

Prescriptions.

  • For professional in vitro diagnostic use only.
  • Follow-up testing with a molecular diagnosis should be considered.
  • The results of the antigen tests should not be used as the sole basis for diagnosing or ruling out a SARS-CoV-2 infection or for determining the status of the infection.
  • Negative results do not exclude a SARS-CoV-2 infection, especially in people who have been in contact with the virus.
  • Positive results indicate the presence of viral antigens, but clinical correlation with the patient's history and other diagnostic information is necessary to determine infection status.
  • Positive results do not rule out bacterial infection or co-infection with other viruses.
  • This test should be administered by a medical professional.

Free shipping in the Netherlands, Belgium & Germany.

Product CodeCORONA-SWAB-ANTI GENEN TEST-Edinburgh-Genetics
ManufacturerEdinburgh Genetics
ConditionNew

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