Key takeaway:
- Superb Diagnostics processes more than 1,000 GI specimens each month and selected the FDA cleared BioCode® Gastrointestinal Pathogen Panel (GPP) for its accuracy, reliability, ease of use, and compatibility with existing laboratory workflows.
- For medium- to high-volume GI testing, platform design can be as important as assay performance. A system built for batch processing and centralized workflows, such as the BioCode® MDx-3000, helps laboratories manage hands-on time and scale throughput as specimen volumes grow.
- Implementation of the BioCode® GPP panel was straightforward, with validation completed in about two weeks and most laboratory personnel comfortable operating the system within one to two weeks.
- Since switching, the laboratory has streamlined its GI PCR panel workflow, reduced intermediate steps, and improved cost efficiency while maintaining the accuracy and reliability that is essential for patient care.
For clinical laboratories, implementing a gastrointestinal (GI) molecular diagnostics platform involves more than selecting an assay. The system must perform reliably, integrate seamlessly into existing workflows, and support the laboratory’s ability to deliver accurate results efficiently.
At Superb Diagnostics, the molecular laboratory processes over 1,000 GI specimens each month, primarily from gastroenterology practices. To better understand the laboratory’s experience, we spoke with Nazrin Islam, Laboratory Manager at Superb Diagnostics, who oversees daily laboratory operations, including workflow optimization, staff management, quality and regulatory compliance, and the implementation and validation of new testing platforms.
Which Molecular Diagnostics Services Do You Offer at Superb Diagnostics?
Superb Diagnostics is an independent clinical laboratory providing diagnostic testing services to healthcare providers across multiple specialties, primarily serving an adult outpatient population. The molecular diagnostics laboratory performs a variety of assays, including gastrointestinal pathogen, wound pathogen, and nail pathogen testing.
Within this testing environment, GI molecular testing represents an important component of routine laboratory operations. At the volumes processed by the lab, maintaining a consistent and efficient workflow is essential for managing specimen throughput while supporting reliable and timely results.
What Kind of Challenges Come with Stool Specimen Testing?
Stool specimens can present unique challenges for molecular laboratories. According to Nazrin, occasional specimen-related inhibition remains one of the primary challenges encountered during GI testing.
This makes assay performance and workflow reliability important considerations when evaluating a GI syndromic testing platform. A system must not only support accurate pathogen detection but also fit within a workflow that allows laboratory staff to process specimens consistently and efficiently.
“For my lab, the goal is straightforward: maintain dependable testing performance while minimizing unnecessary complexity in daily operations.”
How Did You Select a Multiplex GI Panel?
When evaluating multiplex GI testing solutions, Superb Diagnostics focused on several key criteria:
- Accuracy
- Reliability
- Workflow efficiency
- Turnaround time
Following its evaluation, the laboratory selected Applied BioCode’s FDA cleared BioCode® Gastrointestinal Pathogen Panel (GPP) based on its accuracy, reliability, ease of use, and compatibility with existing laboratory workflows.
Since implementation, the laboratory has reported a positive experience, citing consistent assay performance and responsive technical support when needed.
For molecular laboratories, these factors are closely connected. While analytical performance is essential, the system must also be practical for the laboratory professionals who use it every day.
How Does Laboratory Throughput Influence Platform Choice?
For medium- to high-volume GI testing, platform design can be as important as assay performance.
While cartridge-based systems can work well for decentralized or lower-volume testing, laboratories processing more than 1,000 GI specimens per month may benefit from a platform built for batching and centralized workflows.
As specimen volumes increase, laboratories must consider hands-on time, scalability, and the ability to process multiple specimens efficiently.
For Superb Diagnostics, a platform that supports batch processing, streamlined extraction and PCR setup, and high-throughput operation fits more closely with routine laboratory workflows. Ultimately, the best platform is one that supports the laboratory’s testing volume, staffing model, turnaround time goals, and future growth.
What Are the Steps in the Gastrointestinal Pathogen Panel Workflow?
Superb Diagnostics’ workflow includes specimen accessioning, nucleic acid extraction on the KingFisher system, GI PCR panel setup, and testing on the BioCode® MDx-3000. Results are transferred to the LIS for review and reporting.
With more than 1,000 stool specimens processed monthly, an efficient, streamlined workflow helps the laboratory manage volume while maintaining consistency and quality.
Was the BioCode® GPP Panel Easy to Integrate Into Routine Use?
Introducing a new molecular diagnostics platform requires staff to become familiar with both the instrument and its role within the broader laboratory workflow.
According to Nazrin, most laboratory personnel became comfortable operating the MDx-3000 system within approximately one to two weeks.
“This relatively short learning curve helped support the laboratory’s transition into routine testing and facilitated rapid integration into daily operations.”
Beyond initial training, the Applied BioCode team remains available to answer questions and provide additional training resources and educational materials as needed, helping laboratory staff build confidence with the system as it becomes part of their routine workflow.
Was it Easy to Implement and Validate the GI Panel?
Implementation of the BioCode® Gastrointestinal Pathogen Panel (GPP) was straightforward, with validation completed in about two weeks.
On-site training, clear Instruction for Use (IFU) materials, and direct access to the technical support team helped facilitate a smooth transition.
What Matters Most When Selecting a GI Syndromic Testing Platform?
When selecting a GI molecular diagnostics system, Nazrin recommends looking beyond analytical performance alone.
Key factors include accuracy, reliability, workflow efficiency, turnaround time, throughput, scalability, and access to responsive technical support. Laboratories should also consider whether the platform architecture fits their testing volume, batching needs, and operational workflow.
For Nazrin, accuracy and reliability remain the top priorities.
“I would never compromise on accuracy or reliability. A molecular diagnostic system must consistently produce accurate, dependable results.”
Workflow efficiencies add value, but they must support, not replace, diagnostic confidence.
What Impact Has the BioCode® GPP Panel Had on the Laboratory Workflow?
Since switching to the BioCode® Gastrointestinal Pathogen Panel (GPP), Superb Diagnostics has streamlined its GI PCR panel workflow, reduced intermediate steps, and improved cost efficiency.
The platform integrates well into existing processes while supporting efficiency, turnaround time, testing consistency, and scalable throughput.
For busy molecular laboratories, these benefits can help staff manage increasing specimen volumes while maintaining high-quality testing practices and confidence in testing.
How Does Your Team Measure Success?
For the Superb Diagnostics team, success means balancing reliable results with the operational requirements of a high-volume molecular diagnostics laboratory.
A testing platform must ultimately support the laboratory’s clinical and operational priorities including reliable performance, manageable turnaround times, scalable throughput, and an efficient workflow while remaining practical for routine use.
Nazrin Islam
Laboratory Manager at Superb Diagnostics
Are you looking for a gastrointestinal pathogen panel that can support your busy molecular diagnostics operation? Explore BioCode® GPP and contact our team to discuss your needs.