The Benefits of An FDA EUA Authorized Rapid Covid-19 PCR Test

The Benefits of An FDA EUA Authorized Rapid Covid-19 PCR Test

Currently, there are three types of tests for Coronavirus Disease 2019 (COVID-19): molecular, antigen, and antibody tests. Each of these testing methods plays different roles in mitigating the spread and effects of the novel coronavirus. Most of the COVID-19 test results featured in reports from government organizations and laboratories are obtained through polymerase chain reaction (PCR) tests.

Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) requires the use of molecular tests. The polymerase chain reaction (PCR) is a molecular test that detects the genetic material or information of a COVID-19 virus present in the body of any individual suspected to be infected by the virus. The technique is considered the “gold standard” in diagnostic testing due to its ability to detect extremely low concentrations of viral RNA.

Rapid testing is crucial in the fight against the spread of the novel Coronavirus because more than 40% of people with SARS-CoV-2 infection fail to show symptoms of the disease. This type of testing makes it easy for you to achieve mass testing which in turn gives a clear picture of the prevalence of the COVID-19 infection in a target population.

Rapid Covid-19 PCR test was introduced as a response to backlogs and supply shortages. This testing technology has transformed a procedure that used to take days to process samples into one that only takes hours or minutes. This type of testing method creates ample room for contact tracing.

One of the top reasons for developing rapid COVID-19 PCR tests was to ease the long waiting queues which seem to produce a counter effect, increasing the spread of the disease. Rapid COVID-19 PCR tests help a lot to cut back the long wait times. Large queues and failure to get results on time hampers the measures that are imposed to avoid the transmission of the novel coronavirus from one person to another.

Towards the end of October 2020, the U.S. Food and Drug Administration (FDA) had issued 187 individual EUAs for molecular diagnostic tests for SARS-CoV-2. Most of the devices that appear on the agency’s approval list are rapid Covid-19 PCR tests. Most organizations and nations around the globe prefer rapid COVID-19 PCR tests that feature on this list due to the strict standard rules that the agency demands.

The rapid Covid-19 PCR test is a refinement of the initial testing procedures. It comes with greater automation to reduce errors and speed up the process. Rapid PCR technology can perform a diagnosis in hours or minutes unlike traditional labor-intensive methods such as culture which take days to produce results. Knowing your status earlier helps a lot in deciding the right action to take, such as isolation or self-quarantine.

The PCR-based molecular tests are both specific and sensitive, meaning that it is rare to get a false negative result using this diagnostic method. Rapid Covid-19 PCR tests offer the best accuracy, sensitivity, and specificity rates. The use of rapid technology in PCR tests for the COVID-19 virus makes it easier for health providers to identify and isolate individuals that are infected and do contact tracing.

Rapid Covid-19 PCR tests are designed as point-of-care tests, meaning they can be administered in a facility that is closest to the patient, not necessarily a lab. The idea of making COVID-19 testing more accessible allows organizations and nations to achieve mass testing goals. Quick access to screening results makes it easier for them to get a clear picture of the transmission chain.

Currently, rapid Covid-19 PCR tests are considered as game changers before the vaccines are introduced. These tests can be combined with other testing methods such as serology and rapid antigen tests for the development of a more effective approach in dealing with the pandemic. However, rapid testing does not substitute for preventive measures such as hand washing, maintain social distance, and wearing masks in public.

Originally PCR tests were performed in a medical or clinical setting. Now they can be performed in POC settings to detect a positive sample. Detection is achieved with a mobile analyzer in a short period of time. Diagnostic values are very high for a non laboratory setting without the need to transport nasopharyngeal samples. Extraction of the sample is easily collected and results are highly accurate. In conventional PCR, the amplified DNA product, or amplicon, is detected in an end-point analysis. In real-time PCR, the accumulation of amplification product is measured as the reaction progresses, in real time, with product quantification after each cycle. qPCR reactions are run in real-time PCR instruments and the collected data is analyzed by proprietary instrument software. Reagents and buffers are used to prep the sample from the throat swabs to be tested in the analyzer.

Researchers at the university and private sector level have verified the performance of this testing medium. Through Emergency Use Authorization, and CDC guidance, this is a great solution for easy specimens collection and eliminating the need for a clia lab report. This test will show active, current infections in a person’s body. This test is a supplementary tool for healthcare workers including Point of Care. This can also be paired other tests including antibody and antigen testing. While some may think a nose swab test is invasive; it does provide a great diagnostics tool. Persons at a higher risk of contracting Coronavirus compared to the rest of the population or with underlying health conditions can benefit from this new technology.

The polymerase chain reaction (PCR) is a method to rapidly amplify sequences of DNA. During a typical PCR, template DNA (containing the region of interest) is mixed with deoxynucleotides (dNTPs), a DNA polymerase and primers. Primers are short segments of DNA that are complementary with the template DNA upstream of the region of interest and serve as recruitment sites for the polymerase. PCR involves a series of temperature cycles that, although once conducted by moving tubes through various water baths, is now controlled automatically by the use of thermal cyclers, or thermocyclers. Thermocyclers provide tight control over both the reaction temperature and the duration of each temperature step, ensuring efficient amplification. During a typical PCR, cycles of denaturation, annealing and extension are repeated to achieve exponential amplification of the target sequence. Denaturation consists of heating the samples up typically between 94-98°C to cause denaturation of the template DNA. This heat disrupts the hydrogen bonds and base stacking interactions that hold the DNA strands together. Once the strands are separated, the temperature is decreased to the annealing temperature to allow the primers to base pair (or anneal) to complementary regions of the template.

The annealing temperature (typically between 48-72°C) is related to the melting temperature (Tm) of the primers and must be determined for each primer pair used in PCR. During the extension step (typically 68-72°C) the polymerase extends the primer to form a nascent DNA strand. This process is repeated multiple times (typically 25-35 cycles), and because each new strand can also serve as a template for the primers, the region of interest is amplified exponentially. The final step of the PCR is generally a longer, single temperature step (often 5-10 min at 68-72°C) that allows for the completion of any partial copies and the clearance of all replication machinery from the nascent DNA. Once the PCR is complete, the thermal cycler is set to 4°-10°C to maintain product integrity until such time as the tubes can be removed from the machine.

Generally, if you are looking for an In vitro diagnostic (IVD) device that can quickly diagnose a COVID-19 related case, then you can bet on a rapid Covid-19 PCR test. These test devices are easy to use and they offer the greatest potential for screening asymptomatic and pre-symptomatic patients. Based on research, they have contributed a lot to the expansion of testing capabilities in the US.

You do not have to worry about where to get your FDA EUA rapid Covid-19 PCR test online, you can source them from Rapid Connect Medical. Through the company, you can make orders of different quantities at affordable prices, which is based on the quantity of your purchase. This rapid PCR primer has been in depth; if you need more information on the rapid Covid-19 PCR test and how to place your order, feel free to contact the sales team.

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