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A rapid diagnostic test (RDT) is a quick and simple medical diagnostic test. RDTs are appropriate for first or emergency medical screening, as well as usage in medical institutions with minimal resources. They also enable point-of-care testing in primary care for items that were previously only measured by laboratory tests. They deliver same-day results within two hours, usually in less than 20 minutes.
A rapid test is defined by the European Union as a qualitative or semi-quantitative in vitro-diagnostic medical device used single or in a small series that involves non-automated operations and is meant to provide a quick response.
Similar to pregnancy tests, lateral flow tests are arguably the most well-known sort of fast diagnostic test, but alternative techniques, like dipsticks, vertical flow, etc. Anything that can be utilized at the patient’s bedside (point of care). The Cornell FeverPhone, an emerging lateral flow device, has been verified to identify causes of acute febrile disease such as Dengue Virus, Chikungunya Virus, and Malaria in around 15 minutes using a single drop of blood.
A rapid diagnostic test (RDT) based on antigen detection detects the presence of viral proteins, i.e., antigens produced by the COVID-19 virus, in a sample from a person’s respiratory tract within 30 minutes. When appropriate quantities of target antigens are present in the sample, they will bind to particular antibodies attached to one line of paper strip contained in a plastic covering and exhibit a visually visible signal within half an hour in general.
The viral antigens are expressed and identified by RDT while the virus is actively replicating. This test is most useful for detecting acute or early infection.The test’s accuracy is determined by a variety of parameters, including the period since infection began, viral loads, the quality of sample collection and processing, and the optimisation of chemicals inside test kits.
Because COVID-19 is a respiratory illness, similar to influenza, and infected individuals have comparable amounts of influenza virus in respiratory samples as found in COVID-19, the sensitivity of this test may vary. According to the literature, such tests may result in a false negative for half or more of COVID-19 infected patients, depending on the group chosen for testing.
For confirmation, the correctness of these results must be double-checked. Another disadvantage of these tests is that they may provide false-negative results, indicating that the patient is normal but the result is positive owing to detection of other coronaviruses causing common colds other than SARS-CoV-2 by the antibodies contained inside the strip. With the limited evidence now available, WHO does not advocate the use of antigen-detecting RDTs for patient care, however study into their performance and potential diagnostic usefulness is strongly encouraged.
POC testing (POCT) is a fast diagnostic test that is conducted at or near the site of patient treatment. According to the World Health Organisation (WHO), a POC device must meet the following criteria: it must be inexpensive, sensitive, specific, and user-friendly.
LF is a well-established technology with numerous advantages, including: rapid qualitative or semiquantitative tests; ease of use (results can be interpreted by untrained personnel); use for in-field applications in remote areas where high-tech equipment is not available; (prolonged shelf-life (about 1 year) and often without refrigeration; small volumes required; relatively low-cost production; good sensitivity and specificity; and possibility of integration with other technologies).
Despite the benefits mentioned, LF technology has limitations, particularly in terms of reproducibility and sensitivity, such as (1) limited volume around the microliter level; (2) higher volumes that may deteriorate the strip and delay the assay time; (3) pretreatment required for nonliquid samples and a filter must be added to the strip; and (4) integration with electronic/electrochemical systems.
QuantuMDx Group Limited, a UK-based producer of transformative point-of-care diagnostics, has announced the release of Q-POC, a quick, PCR point-of-care diagnostic device.
QuantuMDx’s Q-POC system and its first test, a SARS-CoV-2 detection assay, were CE-IVD approved under the In Vitro Diagnostics Directive (98/79/EC) and will be available at ECCMID.
The Q-POC SARS-CoV-2 assay was studied at St George’s, University of London, to compare clinical performance to existing assays. According to the Development and Assessment of Rapid Technology (DART) Study, the sensitivity specificity and there is no cross reactivity with common commensal or possibly interfering organisms.
Q-POC is a portable PCR system that condenses a complete molecular diagnostic laboratory into a single device that is easy to use, accessible, and inexpensive and provides quick molecular diagnostic testing.
at the point of treatment, with findings in a matter of minutes. Q-POC was created for front-line healthcare providers and may be utilized in a variety of contexts, including emergency departments, intensive care units, maternity centers, clinics, and pharmacies.
The Q-POC SARS-CoV-2 assay is housed in a sealed, single-use test cassette intended for safety, convenience of use, and contamination prevention. On-board reagents are also lyophilized for storage at room temperature, easier shipment, and a longer shelf life.
QuantuMDx’s Q-POC SARS-CoV-2 Assay was developed using the most recent sequencing data to assure 100% coverage of all known SARS-CoV-2 sequences.
