Can CAP Proficiency Testing (PT) Samples be Adequately Processed with Laboratory Automation? A Proof of Concept Study…

Product Validations

August 30, 2019

…That is the question that COPAN Diagnostics’ Scott Oliver, Dr. Sue Sharp and COPAN Italia’s Arnalda Giambra and Laura Navarria set out to discover in a collaborative effort by our team to develop a proof of concept study to show if CAP PT samples can be processed using WASP®DT and WASPLab®. The results were also the subject of a poster presented during the 2019 ASM Microbe conference in San Francisco.

It’s no surprise that the modern Microbiology laboratory is highly regulated. Doctors and patients rely on timely and accurate results from Microbiology laboratories to determine illnesses and prescribe effective treatments. Thankfully, any test run by the lab requires accreditation by passing periodic proficiency testing (PT) given by the College of American Pathologists (CAP).

During the proficiency test, laboratories seeking accreditation for a particular analysis receive unknown samples from CAP. The results from the laboratory are sent and graded for accuracy. If the PT is successfully completed, the lab receives accreditation to perform the microbiology analysis for patient samples.

Proficiency testing for accuracy and precision has been performed in laboratories for over 50 years. During that time, a lot has changed, including the reasons for doing PT. Optional at first, PT is now a federal requirement for hospital and independent laboratories. The role of PT has changed as well in the last 50 years—from one of assessing accuracy to that of evaluating the entire testing process.

With the advent of upfront specimen processing and the use of AI, PT practices are not keeping up with the times. Despite the growing use of laboratory automation, there has been no formal procedure outlined for laboratories to process CAP PT samples using equipment, like WASP®DT and WASPlab®. It is wonderful to proudly mention that COPAN is the first company to offer a proof of concept to the challenge of finding the appropriate automated method for processing CAP proficiency testing samples using automated specimen processors, like WASP®DT!

As part of the study, remnant CAP PT samples were tested to determine a procedure for processing the unknowns on the WASP®DT. The unknown samples were processed manually following the instructions provided by CAP. The results were used as a control to compare four different methods for processing the unknown samples on the WASP®DT.

The study found that the samples processed on the WASP®DT were equivalent to those processed manually. “This study has proven that the CAP unknown swab samples can simply be added to an ESwab™ Amies tube and processed on the WASP®DT exactly as a patient sample would be processed,” said Scott Oliver. “The procedure of placing the CAP swab directly into the ESwab™ Amies and processing it on WASP®DT is incredibly easy and requires almost no additional time to process the CAP unknowns compared to a patient sample” added Oliver.

Although this study is a very promising first step, Scott Oliver pointed out the limitations of using a small number of samples and the promise of future research. For this proof of concept study, only 3 CAP unknowns were tested. Oliver stated that “additional samples have been requested to test further the best method that concluded from this initial study.” 

While the study was presented at the 2019 ASM Microbe conference in San Francisco, many automation users currently doing CAP samples on their specimen processors visited the poster. Several of them asked what method performed the best in the study. “Microbiologists that were just passing by read the title, and almost all of them mentioned that they never thought of the need of processing CAP samples on automation,” Oliver continued, “but after speaking with them, they understood the need to process these CAP samples just like a patient sample on automation.”

Dr. Susan Sharp, a key contributor to the study initiative and design, highlighted the potential impact of this research study. She noted that “a laboratory could take the CAP study and apply it to their own automated processing instrument in order to treat the PT sample more closely to how they treat their patient specimens, which is a CMS requirement. CAP is hoping to get additional information from us and BD to create formal instructions for participants that utilize upfront specimen processing, so this can also be used for their PT testing.

COPAN always pioneers groundbreaking technology and believes in advancing new quality standards. With the invention and rapid adoption of ingenious equipment like the WASP®DT and WASPLab®, regulating bodies like CMS have been slow to adapt. Studies like this one, bridge this gap between what laboratories do in practice and how they validate their procedures. Developing a CAP PT procedure to more accurately represent how samples are processed benefits the patient by ensuring that laboratory practices are appropriately validated for accuracy and precision. Great job team!

Click to read this novel study!