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.
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.
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):
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.
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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:
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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 Flue Rapid Test (15 min result)
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United States FDA EUA IgG/IgM Rapid Test (10 min result)
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.
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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)
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.
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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.
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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
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Product Documents
For access to documents for all our Clinical’s rapid test products please contact us.