Covid-19
Rapid Tests
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As COVID-19 emerged and became a pandemic, Clinical were already on it. We partnered early on with well-established manufacturers who have a long history of developing rapid diagnostic tests technology. Their experts had produced a compact rapid test that could detect the presence of COVID-19 within a matter of minutes.
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Sensitivity of 97.56%
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Specificity of 100%
RAPID
EFFECTIVE
SAFE
STRAIGHTFORWARD
At this time – among healthcare professionals worldwide – there is an urgent need for accurate testing of COVID-19 in a way that is simple, rapid and effective.
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We are proud to supply the Antigen Rapid Test Cassette, which can identify the presence of Covid-19 in a swab sample within 15 minutes.
The test is quick, straightforward, safe – and can be used across any section of the population.
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Antigen Rapid Test (no blood draw):
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The COVID-19 Ag Test is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 viral nucleoprotein antigens in human nose and throat nasopharyngeal and oropharyngeal specimens. This real-time test is a practical solution that is straightforward to implement, even at scale. It is intended for use as an aid in the diagnosis of COVID-19 infections, conducted by a healthcare professional, with results provided directly to patients within 15 minutes with SARSCoV-2.
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The COVID-19 Ag Test detects COVID-19 directly by looking for the presence of specific proteins from the SARS-CoV-2 virus. Thus, antigen detection closes a diagnostic gap. The nucleocapsid protein (N) is ideal for virus detection, as it is highly abundant in the virus and sufficiently specific for SARS-CoV-2. It is one of the 4 most important structural proteins and is involved in replication, transcription and packaging of the viral genome.
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IgM and IgG Rapid Tests (blood draw):
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IgM and IgG are types of immunoglobulins, they are commonly called antibodies. When a person becomes infected with a pathogen such as COVID-19, immunoglobulins are produced as a response. The immunoglobulins bind to specific binding sites (antigens) on the surface of the pathogen, this flags the pathogen as foreign matter. This which triggers a secondary immune response which in turn attacks and clears the pathogen.
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In combination, IgM and IgG can be used to detect both early and late-stage COVID-19 and also long-term immunity after recovery. It is important to understand that the IgG is specific to 2019-nCoV, so by but using this specific IgG and the general IgM, a simple lateral flow immunoassay diagnostic test for the COVID-19 can be produced.
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The COVID-19 IgG/IgM Rapid Test Cassette is suitable for both clinical diagnosis and screening of COVID-19. Provided the test is performed correctly it has a high sensitivity, specificity and accuracy against the 2 biomarkers of COVID-19 (IgM and IgG). In addition, a variety of samples may be used in low sample volumes (single droplets of either whole blood, plasma or serum). This test is a valuable tool in the diagnosis of COVID-19 and may serve as a first-line screening test before RT-PCR Testing.
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Our Clinical Offers Four COVID 19 Rapid Tests:
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EU Registered CE Antigen Rapid Test (15 min result)
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EU Registered CE IgG/IgM Rapid Test (15 min result)
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EU Registered CE Covid or Flu? Rapid Test (15 min result)
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United States FDA EUA IgG/IgM Rapid Test (10 min result)
COVID Health ID App
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How do you manage your testing protocol in an easy, safe, legal and inexpensive way? A softphone application designed for individuals, for use by any organisation, university or businesses wanting instant access to GDPR compliant test results displayed via QR code & reader.
COVID-19 Antigen Rapid Test
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European certified, CE marked & registered, made in EU and USA with a 15-minute result without a lab. Test material is taken from a nasal & throat swab administered by a healthcare professional.
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COVID-19 Antibody (IgG & IgM) Rapid Test
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European certified, CE marked & registered, made in EU & USA with a 15-minute result no lab required. Test material from blood from a finger prick administered by a healthcare professional.
COVID-19 Covid OR Flu? Rapid Test
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European certified, CE marked & registered, made in Germany with a 15-minute result no lab required. Test material is taken from finger prick administered by a healthcare professional.
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FDA (EUA) 10min Antibody Rapid Test
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10-minute result. Test material from venous blood draw administered by a healthcare professional.
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Product Documents
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For access to documents for all our Clinical’s rapid test products please follow the above link. Access will be provided via your email address.
Accuracy of the Antigen Rapid Test Cassette
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While the test is highly accurate, it should also be understood that no test is infallible. To establish the accuracy of the Antigen Rapid Test Cassette there are two important sets of results to consider; Relative Sensitivity and Relative Specificity.
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Where is the 2019 - nCoV IgG / IgM Rapid Test Manufactured ?All test kits supplied by MedFlow Clinical are manufactured by a specialist manufacturer in the European Union and the United States. The reason for us choosing to supply this test kit is that these tests have passed rigorous scrutiny and have USA (FDA) and European approval.
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Is the 2019 - nCOV IgG / IgM Rapid Test CE marked ?Yes, the 2019-nCoV IgG/IgM Rapid Test AND the Antigen Rapid Test are CE marked for professional use and is, therefore, a registered IDV device.
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Is the Test specific for Covid 19?Yes, the IgG that the test detects is specific to COVID-19, a positive result would indicate COVID-19 infection. The IgM is more general, its detection combined with IgG and/or symptoms of COVID-19 would also indicate infections. This rapid test can be used for primary and secondary diagnosis of COVID-19.
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What sample can be used with the text?The test may be used with whole blood, plasma or serum. Whole blood obtained by finger prick in the UK and EU and by venous blood draw in the United States. The type of sample used does not affect the sensitivity or accuracy of the test. The Antigen test is performed using a nasal and throat swab. No blood draw is required for the Antigen Rapid Test.
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Can babies, young children, pregnant women or breast feeding women be tested?"The test may be used with whole blood, plasma or serum. Whole blood obtained by finger prick in the UK and EU and by venous blood draw in the United States. The type of sample used does not affect the sensitivity or accuracy of the test. The Antigen test is performed using a nasal and throat swab. No blood draw is required for the Antigen Rapid Test.
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Is there anyone who should not be tested using the 2019 - nCoV IgG / IgM Rapid Test ?No, testing is a vital strategy for helping to control and understand the virus and may result in improved measures to prevent its spread. However, as a blood sample is required anyone with a blood related health condition such as haemophilia or haemochromatosis should discuss this with a healthcare professional before receiving this test.
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What is the shelf - life of the 2019 - nCoV IgG / IgM Rapid Test ?The shelf-life is 24 months from date of manufacture. Do not use after the expiry date.
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How should the 2019 - nCOV IgG / IgM Rapid Tests be stored ?We recommend that the tests are stored between 2-30°C, this does not mean you should refrigerate them as the tests should be performed at room temperature (15-30°C). Do not freeze.
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When can the 2019 - nCoV IgG / IgM Rapid Test detect an infection ?In general terms detectable levels of IgM are present in blood from day 7 of a new infection and reach a peak level by day 14 after infection. Detectable levels of IgG are normally present after day 14 of an infection. However, there is limited knowledge as to the exact nature of the immune response to COVID-19.
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How does this test compare with RT - PRC test ?The 2019-nCoV IgG/IgM Rapid Test And the Anitigen Rapid Test has been compared with RT-PCR. Specimens from patients with confirmed COVID-19 status (by RT-PCR) were compared against the same specimens tested using the 2019-nCoV IgG/IgM Rapid Test. The accuracy of the rapid test is between 98% and 99% detection.
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Can you get a false positive result ?It is possible to get a false positive result if you have had a past or present infection with a non- COVID-19 coronavirus strain. For this reason, an Antigen test is recommended in conjunction with clinical symptoms to confirm a patient’s current status.
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Can you get a false negative result ?It is possible to get a false negative result, this is because the level of anti bodies present in each whole blood sample varies from person to person. If the amount of COVID-19 antibodies present in the sample is very low, then it may not be detectable for up to 14 days from the onset of infection. For this reason, PCR would be recommended in conjunction with clinical symptoms for anyone showing a negative result.
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How do you know if the test was conducted properly ?The appearance of a coloured line in the control line region (C) indicates that the testing procedure was performed correctly and the proper amount of specimen was absorbed by the test media.
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What should you do if a positive result is indicated ?Follow all government advise. If your IgM line is positive seek urgent medical attention and self quarantine immediately – your status should be confirmed by RT-PCR. If your IgG line is positive it indicates you have had the infection, if you have symptoms you should self-isolate.
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What if the test is positive but the patient doesn't display any symptoms ?Either the patient is infected and may begin to display symptoms in the next few days, or the patient is infected but is asymptomatic. In both cases they should be treated as positive for the virus and should follow current health guidelines.
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What should patients do if a negative result is indicated ?A negative result indicates that the test was not able to detect the presence of antibodies to COVID-19 in the sample – it does not rule out the presence of infection. If they have symptoms then a RT-PCR Test for more accurate confirmation of you status.
Covid-19 Rapid Test Kit