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Covid-19 Rapid Tests

Our product: COVID-19 IgG/IgM rapid test cassettes —
The COVID-19 IgG/IgM Rapid Test Cassette is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to COVID-19 in whole blood, serum or plasma specimen. This test consists of two components, an IgG and an IgM. To perform a finger prick test, a sample of whole blood is placed at the inlet before the addition of a buffer solution. Any IgG/IgM present in the sample will bind to the gold- COVID-19 antigen conjugate and flow to the two test lines, which will capture any
IgG/IgM in the sample. The control line will then capture the other gold-antibody conjugate, confirming the test is valid. In about 10 minutes, test lines will appear for both IgG and IgM for a positive result, and a control line for quality control. This test has the advantages of being portable, rapid and low cost.

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RAPID
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EFFECTIVE
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SAFE
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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.

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.

Antigen Rapid Test (no blood draw):

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.

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.

IgM and IgG Rapid Tests (blood draw):

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.

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.

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.

 BioClinical Offers Four COVID 19 Rapid Tests:

  1. EU Registered CE Antigen Rapid Test (15 min result)

  2. EU Registered CE IgG/IgM Rapid Test (15 min result)

  3. EU Registered CE Covid or Flue Rapid Test (15 min result)

  4. United States FDA EUA IgG/IgM Rapid Test (10 min result)

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Accuracy of the Antigen Rapid Test Cassette

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.

Ease of administration is an important factor here. A simple sample collection (Whole Blood/Serum/Plasma) is all you need, and the simplest approach is a finger prick. It can be administered at point of
care, in a few minutes, and tell the healthcare professional if the person is infected now or is immune.
This is a summary of technical details for our IgG/IgM testing kits.
- USA manufacturer
- COVID-19 specific
- Immediate results (10 minutes)
- No swabbing. Simple sample collection (finger prick)
- FDA EUA approved
- Used globally
- Large clinical evaluation
- IgM results: 100% sensitivity; 98% specificity; 98% accuracy
- IgG results: 97% sensitivity; 98% specificity; 97% accuracy
- Shelf life is 24 months
- Stored between 4-30°C. Test should be performed at room temperature (15-30°C)

  • Where is the 2019-nCoV IgG/IgG 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.
  • Is the 2019-nCoV IgG/IgG 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.
  • What does the 2019-nCoV IgG/IgG rapid test CE detect?
    The test detects IgG and IgM immunoglobulins (antibodies) to the COVID-19 virus in human whole blood, serum or plasma. The Antigen Rapid Test is performed using a nasal and throat swab.
  • Is the test specific for COVID19?
    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.
  • What Sample can be used with the test?
    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.
  • Can babies, young children, pregnant women or breast feeding women be tested?"
    Yes, there are no issues with testing babies and young children. There is no harm to pregnant or breast feeding women or their babies when performing a test.
  • Is there 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.
  • 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.
  • How should the 2019-nCoV IgG/IgM Rapid Test 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.
  • When can the 2019-nCoV IgG/IgM Rapid detect an infaction?
    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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Faq

IgG/IgM as part of a vaccination program –
 

The reason IgG/IgM is a very important element of a COVID-19 vaccination strategy is simply to:

1) better manage our limited resources by not offering a vaccine to somebody who is already protected (has antibodies/immunity— IgG)

2) not subjecting a person to a vaccine when they are fighting an infection at that same time (IgM). Knowing that over 70% of infected persons are asymptomatic, it is
   important to perform such a quick test just before administering the vaccine— same location, same time, no extra steps for a laboratory or anything like that at all.

 

IgG/IgM for managing patients’ recovery –
Another great use for IgG/IgM rapid tests is for managing active COVID-19 patients. At present, a patient is diagnosed with COVID-19 through a PCR test. Additionally, a PCR test is often repeated 2-5 times as part of the treatment protocol to check if a patient can be ‘cleared’. PCR test kits have some limitations: they take at least 2 hours to obtain a result, they require certified laboratories and personnel and they often times continue to give a ‘positive’ result well after the patient has stopped being contagious (and well into their recovery. Countries like the USA have already adopted the rapid IgG/IgM testing because it is faster, more accurate/comprehensive, and being a more cost efficient solution.

Understanding IgG/IgM testing—
IgG/IgM (Immunoglobulin G and Immunoglobulin M) testing is one of the latest and more effective tools on the market today for managing the pandemic. IgG/IgM testing had been adopted by governments around the world (e.g. the US, the UK) to strengthen their efforts in: 1) controlling the pandemic, 2) better managing their vaccination strategy delivery, and 3) managing the process of clearing patients after they’ve been infected with COVID-19.
Our immune system makes antibodies to protect our bodies from pathogens (e.g. viruses like COVID-19). An immunoglobulin test measures the level of certain types of these antibodies in the blood. An IgG (most common antibody in the blood) protects our bodies against viral and bacterial infections. This, though, takes time to form in our bodies after an infection or an immunization (not immediately upon an infection). An IgG test basically tells you if the person had been infected with a certain virus a while back and their body has already formed antibodies (protection) for that virus. An IgM on the other hand is the largest immunoglobulin in humans and it is the first antibody to be produced when a person becomes infected. It is present in our blood much sooner than IgG. In summary, IgM is our first line of defense when we get infected with a virus, while IgG is what develops in our system at a later stage. Levels of IgG rise later than IgM which would indicate previous exposure to COVID-19. In combination, IgM and IgG can be used to detect both early and late stage COVID-19 and also long term immunity after recovery. A healthcare professional would do an IgG/IgM test to check if a person has an infection now or is immune from having a particular infection due to a previous infection or an immunization.

COVID-19 Antigen Rapid Test

USA certified, CE marked & registered, made in USA 15-minute result without a lab. Test material is taken from a nasal & throat swab administered by a healthcare professional.

COVID-19 Antibody (IgG & IgM) Rapid Test

USA certified, CE marked & registered, made in USA with a 15-minute result no lab required. Test material from blood from a finger prick administered by a healthcare professional.

COVID-19 OR Flu? Rapid Test

USA certified, CE marked & registered, made in USA with a 15-minute result no lab required. Test material is taken from finger prick administered by a healthcare professional.

FDA (EUA) 10min Antibody Rapid Test

10-minute result. Test material from venous blood draw administered by a healthcare professional.

Contact us regarding this product

Product Documents

For access to documents for all our Clinical’s rapid test products please contact us.

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