Simplify PCR testing by leveraging your LIS

Polymerase chain reaction (PCR) testing has become a cornerstone of molecular diagnostics, enabling the detection of specific genetic material from pathogens or an individual's genome.

Initially developed by Kary Mullis in 1983, PCR testing has revolutionized the field of molecular biology and medical diagnostics, providing a highly sensitive method for amplifying tiny amounts of DNA.  Now, having experienced the COVID-19 pandemic, “PCR” has become a widely known acronym.

In this article, we gain a basic understanding of PCR testing and how labs can better leverage their laboratory information system (LIS) to assist with it. For labs with under-utilized analyzers from the COVID-19 era, we also make suggestions of how to pivot into more PCR testing, expanding your laboratory’s testing menu.

PCR testing works by amplifying a small segment of DNA or RNA to generate copies of a particular sequence. This amplification allows for the detection of even the smallest amounts of genetic material, making PCR an invaluable tool for diagnosing infectious diseases, genetic disorders, and even cancers.

The process generally involves:

• Sample collection: Obtaining a sample from the patient—blood, saliva, tissue, or other body fluids
• DNA/RNA extraction: Isolating the genetic material from the sample
• Amplification: Using specific primers and a DNA polymerase enzyme to amplify the target sequence through thermal cycling
• Detection: Identifying the amplified genetic material using methods such as gel electrophoresis, fluorescence, or real-time PCR (qPCR)

PCR testing has been instrumental in controlling the spread of infectious diseases, including the recent COVID-19 pandemic. Its high sensitivity and specificity make it an essential tool in modern diagnostics.

A laboratory information system (LIS) plays a critical role in managing and streamlining the PCR testing workflow. Lab management software helps laboratories manage patient data, sample tracking, test results, and reporting.

Here’s how an LIS enhances the PCR testing process:

• Data management: An LIS efficiently manages patient information, ensuring that all data is accurately recorded and easily accessible. This reduces the risk of errors and improves the overall quality of the testing process.
• Sample tracking: With an LIS, laboratories can track samples from collection to results. This ensures that samples are not lost or mislabeled, maintaining the integrity of the testing process.
• Automation: Many modern LIS systems integrate with PCR instruments, automating data transfer and reducing manual input. This not only speeds up the process but also minimizes the potential for human error.
• Result reporting: An LIS can automatically generate and distribute test reports to healthcare providers, facilitating timely diagnosis and treatment.
• Quality control: LIS systems often include features for monitoring and maintaining quality control, ensuring that all tests meet regulatory standards.

By integrating an LIS into the PCR testing workflow, laboratories can enhance efficiency, accuracy, and reliability, ultimately improving patient care.

Going beyond the basics, labs using the nation’s leading laboratory information system, CGM LABDAQ, can adopt two essential software options to greatly increase the efficiency of their PCR testing workflow and reporting.

Workflow Management

Workflow Management for CGM LABDAQ increases your lab's efficiency by facilitating workflows where multiple intermediate steps, with or without results, are part of an overall process to generate a reportable result.

Workflow Management saves time. Users can easily query pending orders and build plate maps for each workflow step. This alleviates manual documentation and plate map assignment.

Workflow Management helps labs:

• Configure and assign test plates, including assigning specific wells for quality control
• Build a worklist of specimens to be tested for each workflow step
• Assign specimens to specific plate positions
• Employ rules to coordinate testing across multiple workflow steps
• Export well assignments to analyzers prior to testing
• Import results for each well from the analyzer

PCR Linking

PCR Linking for CGM LABDAQ simplifies PCR setup and makes it easier to report pathogen and antibiotic sensitivities.

With PCR Linking, you can define the linkages between antibiotics and pathogens, antibiotics and resistance markers, and pathogens and resistance markers. With this information, PCR Linking will automate the reporting of a sensitive or resistant antibiotic result—no complex functions required.

Users can also update linkages by simply checking or unchecking one of the boxes in your PCR Linking table.

PCR Linking helps labs:

• Define linkages between antibiotics, pathogens, and resistance markers
• Simplify PCR setup and reporting, eliminating the need for complex functions
• Automate antibiotic sensitivity reporting

Scalable and customizable, users benefit from a powerful catalog of software options for CGM LABDAQ that greatly increase a lab's capabilities. Tailor your LIS to meet the unique needs of your specific laboratory.

The COVID-19 pandemic saw laboratories making a massive investment in PCR analyzers and related infrastructure. As the demand for COVID-19 testing decreases, there is a significant opportunity to repurpose these analyzers for other diagnostic purposes.

Here are some potential applications:

• Infectious disease testing: PCR analyzers can be used to detect a wide range of infectious agents, including influenza, HIV, hepatitis, and more. By repurposing COVID-19 analyzers, laboratories can expand their testing capabilities to include these pathogens.
• Genetic testing: PCR is a fundamental technique in genetic testing, used to identify genetic mutations associated with various inherited disorders. Repurposed analyzers can facilitate carrier screening, prenatal testing, and personalized medicine.
• Oncology: PCR is used in oncology to detect genetic mutations and alterations associated with different types of cancer. This can aid in early diagnosis, prognosis, and monitoring of treatment efficacy.
• Veterinary diagnostics: Just as PCR is essential for human health, it is equally valuable in veterinary medicine. Repurposed analyzers can be used to diagnose infectious diseases in animals, contributing to better animal health and preventing zoonotic diseases that can transfer to humans.
• Pharmaceutical research: In pharmaceutical research and development, PCR is used to study genetic expressions, drug resistance, and the effects of new drugs. Repurposing COVID-19 analyzers for this purpose can accelerate research and development timelines, leading to faster drug discovery and development.

PCR testing has proven to be a versatile and invaluable tool in diagnostics and research across various fields. The integration of laboratory information systems has further enhanced the efficiency, accuracy, and reliability of PCR testing, making it more accessible and streamlined.

As the demand for COVID-19 testing decreases, the opportunity to repurpose these sophisticated PCR analyzers for other diagnostic and research purposes offers a promising avenue for maximizing their utility.

Armed with the CGM LABDAQ Laboratory Information System and software options such as Workflow Management and PCR Linking, your lab can continue to leverage the technological advancements made during the pandemic to improve public health and safety in numerous other areas.