What is PCR and How We Test for COVID-19

What’s done in the lab – often stays in the lab, and not just for contamination reasons. For most clinical settings, the laboratory often represents unchartered territory filled with complex instrumentation for complex clinical presentation. And once diagnostic testing begins, interference might generate mistakes. This often makes interactions between lab technicians and medical staff difficult. Precision is key; attention to detail and to the process is paramount for accurate results.

But what happens behind closed doors? And what tests are being run?

How effective are they, and what do they actually show?

For Integrity Laboratories, it comes down to a highly-trusted method based on the PCR technique or the Polymerase Chain Reaction technique.

For years, researchers faced a common issue when it came to testing samples for pathogens. The amount of a pathogen within a sample might be so small that it was too difficult to determine its presence. Waiting for it to replicate enough to measure meant potentially risking the health of the host, so a better method of testing needed to be created. To compensate, a technique of amplifying key genetic sequences associated with the pathogen – or more generally, to replicate certain DNA sequences used to identify it – allows scientists to better observe the presence of a pathogen. Furthermore, it can be quantified so that scientists can even determine how much DNA is present. This technique, named Real-Time PCR or Quantitative PCR, refers to the introduction of fluorescent signals that can be monitored in real-time to express how much of the specified DNA sequences are present. Consequently, scientists can now determine if a pathogen is there and compare how much of it may be present in a sample (relative to a pathogen-free sample).

A Brief History of PCR

Developed originally over 40 years ago by American biochemist Kary Mullis, this technique is used across various scientific fields from molecular biology to biochemistry. PCR was so groundbreaking that Dr. Mullis went on to receive the Nobel Prize for Chemistry in 1993.

Dr. Kary Banks Mullis (December 28, 1944 – August 7, 2019, American Biochemist. (www.themedicinemaker.com)

PCR has become instrumental in basic science research and is a highly-trusted standard procedure in research. Moreover, great strides in research have resulted in a specialized recipe that allows this test to be incredibly adaptive to a variety of different needs. Whether assessing DNA markers in animals, plants, or other organisms, or discovering the presence of microbes in foods for safety, PCR has been a skeleton key in significantly advancing the adaptability and integrity of many studies. In the field of infectious disease, PCR has functioned in an even more dynamic matter: by saving time and lives.

Defying the Status Quo

In the case of bacterial infections, standard laboratory testing across hospitals and clinical offices alike have historically relied on “cell culture studies.” Although reliable and easy to perform, this method requires time for a sample to grow – or be cultured – in a lab to help researchers identify the pathogen. In the case of a patient’s wellbeing, this could be days, if not weeks before they get results. The impact of this can be seen no further than the prevalence of antibiotic resistance: a direct result of physicians that prescribe a generic treatment while waiting on results.

But now with PCR, the necessity to wait and risk a patient’s health can be remedied. Although some protocols can vary depending on the lab, PCR testing on average is a single day’s work.

And as Integrity Laboratories has focused on adapting PCR technology into a specialized and integrative platform we call Intercept-PCR, our FDA recognized test shows 100.00% accuracy in determining the presence of SARS-CoV-2 responsible for COVID-19.

With revolutionary technology, years of experience, and the leadership of a team of specialized technicians, our process for COVID-19 testing is neither convoluted nor secretive. We approach each sample with a comprehensive and precise method for testing that exemplifies decades of research, all readily traceable with a simple google search.  We are here to lead with transparency and real results. We approach every sample that enters our lab with integrity because every sample represents an individual waiting for an important answer. We don’t spend our day running samples, we spend our day giving real people, real data – backed by our devotion to quality and speed so that you can have sound of mind with your results.

That’s the Integrity Laboratories way.

Integrity Laboratories began testing for SARS-CoV-2 (COVID-19) under Emergency Use Authorization (EUA) on March 23.

Please direct all inquiries to covid19@integritylaboratories.com for immediate review.

FDA Authorization Letter   |   FDA EUA Summary

CARES Act Statement