The coronavirus pandemic has driven much-needed innovation, particularly in diagnostic testing. For businesses, schools and other facilities to reopen safely, COVID-19 testing has become routine practice. As a result, labs are working overtime to conduct polymerase chain reaction (PCR) diagnostic testing to meet this increased demand.
Unfortunately, processing these diagnostics is inherently manual. For example, health care workers, rather than machines, handle each swab tip. But despite these limitations, lab automation software can ensure thorough data integrity throughout the PCR diagnostic workflow.
Data integrity is critical to diagnostic testing. When the data link between samples and the patients they come from breaks, it means individuals or groups of people could receive false results.
False positives can generate fear and debilitating economic hardships, as recipients may forego work for an unnecessary quarantine. False negatives can discourage people from seeking medical care and enable community spread.
Bad results become increasingly problematic for diagnostic labs that batch multiple samples into a single run (pooling). To increase throughput, labs pool several samples in a single assay. If the pooled test comes back negative, then all the samples are negative. If it comes back positive, each sample must be retested individually. As a result, false negatives in pooled tests only multiply errors.
In addition to putting patients at risk, bad results slow test processing, as labs must circle back to resolve these issues. To improve data integrity in COVID-19 diagnostic workflows, companies such as Biosero, have developed innovative systems, like the Green Button Go™ Automation Scheduling Software, to improve data integrity by controlling error-prone segments and tracking critical events, such as moving samples between barcoded plates.
Preventing Inaccurate Inputs
A patient’s data must always remain closely tied to their sample. This may seem like a no-brainer, but too often, ineffective data integrity safeguards thwart accurate results.
Human error is a significant contributor. Rushed lab technicians may forget to scan the barcode associated with a patient sample during accessioning. When manually inputting data, they may enter incorrect information or fail to upload it. Technicians may even forget to scan an entire batch of plates.
To remedy this, Biosero designed a custom screen that only allows lab workers to move forward when they have correctly completed each essential step. For example, they can’t press the GO button to start a run until they scan the barcode. The software also ensures that all data from each plate must be captured and linked to that specific run before the process can advance. Green Button Go software ensures each step is followed precisely.
As the lab technician scans a barcode, the software populates multiple fields in the database with patient information. If the software finds crucial information is missing, it stops the process until the error is corrected.
Once the run is completed, a dialog box tells the technician the run has finished and confirms the data has been saved and transferred for analysis. Only then can they start a new run.
By ensuring lab technicians enter all necessary information correctly before proceeding, as well as tracking important events in the workflow where data integrity or sample location can be lost, Green Button Go software maintains the link between patient samples and the data PCR diagnostics produce. Even the most inexperienced lab workers can effectively complete their runs and return accurate results.
In addition to maintaining data integrity, Green Button Go software can help manage consumable expenses, as labs rerun fewer samples. It also increases walk away time as technicians spend less time troubleshooting process errors. Most importantly, patients and clinicians will have high confidence that the results they receive are accurate, minimizing the need for retesting.
About the Author:
Donald Chow is an Applications Expert at Biosero.