Rapid antigen test

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Rapid antigen test
Synonyms Rapid antigen detection test (RADT), lateral flow test, lateral flow device, rapid test, Antigen rapid test
PurposeTo diagnose infections
A COVID-19 Rapid Antigen test(top) with a Covid-19 Rapid Antigen and a Influenza A&B Rapid Antigen Test(bottom) COVID-19-Antigen-with-Influenza-A-B-Rapid-Antigen-Combo.jpg
A COVID-19 Rapid Antigen test(top) with a Covid-19 Rapid Antigen and a Influenza A&B Rapid Antigen Test(bottom)

A rapid antigen test (RAT), sometimes called a rapid antigen detection test (RADT), antigen rapid test (ART), or loosely just a rapid test, is a rapid diagnostic test suitable for point-of-care testing that directly detects the presence or absence of an antigen. RATs are a type of lateral flow test detecting antigens, rather than antibodies (antibody tests) or nucleic acid (nucleic acid tests). Rapid tests generally give a result in 5 to 30 minutes, require minimal training or infrastructure, and have significant cost advantages.[ citation needed ] Rapid antigen tests for the detection of SARS-CoV-2, the virus that causes COVID-19, have been commonly used during the COVID-19 pandemic.

Contents

For many years, an early and major class of RATs—the rapid strep tests for streptococci—were so often the referent when RATs or RADTs were mentioned that the two latter terms were often loosely treated as synonymous with those. Since the COVID-19 pandemic, awareness of RATs is no longer limited to health professionals and COVID-19 has become the expected referent, so more precise usage is required in other circumstances.

RATs are based on the principle of antigen-antibody interaction. They detect antigens (generally a protein on the surface of a virus). A linear chromatography substrate (a porous piece of material) bears an indicator line, onto which antibodies directed against the target antigen are fixed. Antibodies are also fixed to a visualisation marker (generally a dye, though sometimes these antibodies are modified to fluoresce), to which the sample is added. Any virus particles present will bind to these markers. This mix then travels through the substrate through capillarity. When it reaches the indicator line, virus particles are immobilised by the antibodies fixed there, along with the visualisation marker, allowing concentration and thus visual detection of significant levels of virus in a sample. [1]

A positive result with an antigen test should generally be confirmed by RT-qPCR or some other test with higher sensitivity and specificity. [1]

Uses

Common examples of RATs or RADTs include:

COVID-19 rapid antigen tests

SARS-CoV-2 rapid tests showing a negative and a positive result Lateral flow covid 19 negative and positive test.jpg
SARS-CoV-2 rapid tests showing a negative and a positive result

Rapid antigen tests for COVID-19 are one of the most useful applications of these tests. Often called lateral flow tests, they have provided global governments with several benefits. They are quick to implement with minimal training, offered significant cost advantages, costing a fraction of existing forms of PCR testing and give users a result within 5–30 minutes. Rapid antigen tests have found their best use as part of mass testing or population-wide screening approaches. [3] They are successful in these approaches because in addition to the aforementioned benefits, they identify individuals who are the most infectious and could potentially spread the virus to a large number of other people. [4] This differs slightly from other forms of COVID-19 tests such as PCR that are generally seen to be a useful test for individuals.[ citation needed ]

As early as February 2021, the US Department of State considered the antigen test suitable for entry to the country. [5] In Canada, although the antigen test appeared to be no route to entry in January 2021, [6] Health Canada in August 2021 made available subsidized at no cost rapid antigen tests "to more small and medium-sized organizations through new pharmacy partners". [7]

Scientific basis and underlying biology

RATs are immunochromatographic assays which give results that can be seen with the naked eye (with or without special illumination, such as a UV lamp). They are qualitative in nature, although within a certain range it is possible to make rough order of magnitude estimates of viral load from the results. RATs are generally screening tests, with relatively low sensitivity and specificity, thus results should be evaluated on the basis of confirmatory tests like PCR testing or western blot.[ citation needed ]

One inherent advantage of an antigen test over an antibody test (such as antibody-detecting rapid HIV tests) is that it can take time for the immune system to develop antibodies after infection begins, but the foreign antigen is present right away. Although any diagnostic test may have false negatives, this latency period can open an especially wide avenue for false negatives in antibody tests, although the particulars depend on which disease and which test are involved. A rapid antigen test typically costs around US$5 to manufacture.[ citation needed ]

Related Research Articles

<span class="mw-page-title-main">Virology</span> Study of viruses

Virology is the scientific study of biological viruses. It is a subfield of microbiology that focuses on their detection, structure, classification and evolution, their methods of infection and exploitation of host cells for reproduction, their interaction with host organism physiology and immunity, the diseases they cause, the techniques to isolate and culture them, and their use in research and therapy.

<span class="mw-page-title-main">Diagnosis of HIV/AIDS</span> Immunological test

HIV tests are used to detect the presence of the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), in serum, saliva, or urine. Such tests may detect antibodies, antigens, or RNA.

<span class="mw-page-title-main">Respiratory syncytial virus</span> Species of a virus

Respiratory syncytial virus (RSV), also called human respiratory syncytial virus (hRSV) and human orthopneumovirus, is a common, contagious virus that causes infections of the respiratory tract. It is a negative-sense, single-stranded RNA virus. Its name is derived from the large cells known as syncytia that form when infected cells fuse.

<span class="mw-page-title-main">Immunostaining</span> Biochemical technique

In biochemistry, immunostaining is any use of an antibody-based method to detect a specific protein in a sample. The term "immunostaining" was originally used to refer to the immunohistochemical staining of tissue sections, as first described by Albert Coons in 1941. However, immunostaining now encompasses a broad range of techniques used in histology, cell biology, and molecular biology that use antibody-based staining methods.

<span class="mw-page-title-main">Seroconversion</span> Development of specific antibodies in the blood serum as a result of infection or immunization

In immunology, seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization, including vaccination. During infection or immunization, antigens enter the blood, and the immune system begins to produce antibodies in response. Before seroconversion, the antigen itself may or may not be detectable, but the antibody is absent. During seroconversion, the antibody is present but not yet detectable. After seroconversion, the antibody is detectable by standard techniques and remains detectable unless the individual seroreverts. Seroreversion, or loss of antibody detectability, can occur due to weakening of the immune system or waning antibody concentration over time. Seroconversion refers the production of specific antibodies against specific antigens, meaning that a single infection could cause multiple waves of seroconversion against different antigens. Similarly, a single antigen could cause multiple waves of seroconversion with different classes of antibodies. For example, most antigens prompt seroconversion for the IgM class of antibodies first, and subsequently the IgG class.

<span class="mw-page-title-main">Lateral flow test</span> Immunochromatographic testing devices

A lateral flow test (LFT), is an assay also known as a lateral flow device (LFD), lateral flow immunochromatographic assay, or rapid test. It is a simple device intended to detect the presence of a target substance in a liquid sample without the need for specialized and costly equipment. LFTs are widely used in medical diagnostics in the home, at the point of care, and in the laboratory. For instance, the home pregnancy test is an LFT that detects a specific hormone. These tests are simple and economical and generally show results in around five to thirty minutes. Many lab-based applications increase the sensitivity of simple LFTs by employing additional dedicated equipment. Because the target substance is often a biological antigen, many lateral flow tests are rapid antigen tests (RAT or ART).

In the diagnostic laboratory, virus infections can be confirmed by a myriad of methods. Diagnostic virology has changed rapidly due to the advent of molecular techniques and increased clinical sensitivity of serological assays.

<span class="mw-page-title-main">Rapid strep test</span> Test for strep throat

The rapid strep test (RST) is a rapid antigen detection test (RADT) that is widely used in clinics to assist in the diagnosis of bacterial pharyngitis caused by group A streptococci (GAS), sometimes termed strep throat. There are currently several types of rapid strep test in use, each employing a distinct technology. However, they all work by detecting the presence of GAS in the throat of a person by responding to GAS-specific antigens on a throat swab.

<span class="mw-page-title-main">Influenza</span> Infectious disease, often just "the flu"

Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms begin from one to four days after exposure to the virus and last for about 2–8 days. Diarrhea and vomiting can occur, particularly in children. Influenza may progress to pneumonia, which can be caused by the virus or by a subsequent bacterial infection. Other complications of infection include acute respiratory distress syndrome, meningitis, encephalitis, and worsening of pre-existing health problems such as asthma and cardiovascular disease.

Virus quantification is counting or calculating the number of virus particles (virions) in a sample to determine the virus concentration. It is used in both research and development (R&D) in academic and commercial laboratories as well as in production situations where the quantity of virus at various steps is an important variable that must be monitored. For example, the production of virus-based vaccines, recombinant proteins using viral vectors, and viral antigens all require virus quantification to continually monitor and/or modify the process in order to optimize product quality and production yields and to respond to ever changing demands and applications. Other examples of specific instances where viruses need to be quantified include clone screening, multiplicity of infection (MOI) optimization, and adaptation of methods to cell culture.

<span class="mw-page-title-main">NS1 antigen test</span> Test for dengue fever

NS1 antigen test is a test for dengue, introduced in 2006. It allows rapid detection on the first day of fever, before antibodies appear some 5 or more days later. It has been adopted for use in some 40 nations. The method of detection is through enzyme-linked immunosorbent assay. India has introduced in 2010 the NS1 test costing 1,600 rupees at a private hospital in Mumbai.

<span class="mw-page-title-main">Molecular diagnostics</span> Collection of techniques used to analyze biological markers in the genome and proteome

Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. In medicine the technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients, and in agricultural biosecurity similarly to monitor crop- and livestock disease, estimate risk, and decide what quarantine measures must be taken.

DiaSorin is an Italian multinational biotechnology company that produces and markets in vitro diagnostics reagent kits used in immunodiagnostics and molecular diagnostics and since July 2021, it is also active in the Life Science business. The group was founded in 2000 and is headquartered in Saluggia, Italy. Its production is at several plants located in Europe and the United States: Saluggia and Gerenzano (Italy), Dietzenbach (Germany), Stillwater, Minnesota (US), Dartford (UK). Following the acquisition of Luminex, the company acquired five additional production plants located in the United States and in Canada (Toronto). The company is a constituent of the FTSE MIB index.

QuidelOrtho Corporation is a major American manufacturer of diagnostic healthcare products that are sold worldwide.

<span class="mw-page-title-main">Reverse Transcription Loop-mediated Isothermal Amplification</span>

Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a one step nucleic acid amplification method to multiply specific sequences of RNA. It is used to diagnose infectious disease caused by RNA viruses.

<span class="mw-page-title-main">Rapid diagnostic test</span>

A rapid diagnostic test (RDT) is a medical diagnostic test that is quick and easy to perform. RDTs are suitable for preliminary or emergency medical screening and for use in medical facilities with limited resources. They also allow point-of-care testing in primary care for things that formerly only a laboratory test could measure. They provide same-day results within two hours, typically in approximately 20 minutes.

<span class="mw-page-title-main">COVID-19 testing</span> Diagnostic testing for SARS-CoV-2 virus infection

COVID-19 testing involves analyzing samples to assess the current or past presence of SARS-CoV-2. The two main types of tests detect either the presence of the virus or antibodies produced in response to infection. Molecular tests for viral presence through its molecular components are used to diagnose individual cases and to allow public health authorities to trace and contain outbreaks. Antibody tests instead show whether someone once had the disease. They are less useful for diagnosing current infections because antibodies may not develop for weeks after infection. It is used to assess disease prevalence, which aids the estimation of the infection fatality rate.

Viral disease testing is the use of a variety of testing techniques for a variety of purposes, including diagnosing conditions, assessing immunity and understanding disease prevalence. The primary approaches include DNA/RNA tests, serological tests and antigen tests.

<span class="mw-page-title-main">COVID-19 rapid antigen test</span> Diagnostic test for a SARS-CoV-2 infection

COVID-19 rapid antigen tests or RATs, also frequently called COVID-19 lateral flow tests or LFTs, are rapid antigen tests used to detect SARS-CoV-2 infection (COVID-19). They are quick to implement with minimal training, cost a fraction of other forms of COVID-19 testing, and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches. Many RATs can be used for self-testing, in which an individual "collects their own specimen… and interpret[s] their test result themselves".

References

  1. 1 2 "SARS-CoV-2 (Covid-19): Rapid Antigen Test for Diagnosis Biotrend". www.biotrend.com. Retrieved 2022-03-16.
  2. Stewart EH, Davis B, Clemans-Taylor BL, Littenberg B, Estrada CA, Centor RM (2014-11-04). "Rapid antigen group A streptococcus test to diagnose pharyngitis: a systematic review and meta-analysis". PLOS ONE. 9 (11): e111727. Bibcode:2014PLoSO...9k1727S. doi: 10.1371/journal.pone.0111727 . PMC   4219770 . PMID   25369170.
  3. "Press corner". European Commission – European Commission. Retrieved 2021-03-20.
  4. Guglielmi G (September 2020). "Fast coronavirus tests: what they can and can't do". Nature. 585 (7826): 496–498. Bibcode:2020Natur.585..496G. doi:10.1038/d41586-020-02661-2. PMID   32939084. S2CID   221768935.
  5. "COVID-19 Testing Required for U.S. Entry". U.S. Department of State. 12 February 2021. Retrieved 3 August 2021.
  6. Pihach, Michael (25 January 2021). "Why does Canada accept PCR (instead of antigen) tests? Health Canada explains". PAXGlobalmedia.
  7. "Government of Canada makes rapid antigen tests available to more small and medium-sized organizations through new pharmacy partners". Verizon Media. yahoo! finance. 14 August 2021.