3 Ways Custom QC Improves Precision in Your Test Results

For diagnostic laboratories, any test result is only as good as the quality control measures that validate your analytical processes. Accurate, trustworthy conclusions come down to control, and there’s no better way to control your testing requirements than creating a custom QC mix in-house.

But producing the exact concentrations and analytes your lab needs is costly, tedious, and time-consuming. Instrument makers can supply you with reagents and calibrators, but these are optimized for specific tests, products, and conditions distinct from your lab. Suddenly, your results are subject to the influence of variables beyond your control.

The solution? Independently manufactured, 3rd party QC materials deliver an unbiased check-and-balance on analytical performance across multiple testing platforms. Custom QC developed to your specifications enables you to identify errors in your test results much faster.

When it comes down to it, who else is better suited to be in charge of your testing?

How 3rd Party Quality Controls Puts You in the Driver’s Seat

QC supplied by instrument manufacturers may claim to mimic true patient specimens. But manufacturers can use buffers, stabilizers, or animal products in their QC materials to secure a response based on their calibrations. Outside of specific situations where safety or feasibility dictate the use of synthetic material, real human QC material is the only way to go.

Why? If your 3rd party controls are made with 100% REAL™ human matrices, you protect the precision and accuracy of your results. Plus, your lab gains the ability to identify potential errors much faster because your matrices align with your patient specimens. 

Using quality 3rd party QC materials with analytes and concentrations spiked to your exact specifications delivers major benefits to your lab. At UTAK, we think of these advantages as “The 3 Cs”:

1. Consolidation: Streamline Processes and Protect Your Budget

Diagnostic labs face a consistent need to reduce costs, and inflation has only increased this pressure. Using custom 3rd party QCs grants you the flexibility to consolidate the analyte products you need in a single order.

For example, your lab may need 20 analytes to support your testing. But your supplier may only offer these 20 analytes across multiple products, requiring you to mix and match from separate vials until you get what you need. This introduces unnecessary complexity and risk. 

Sure, stock products may seem quicker — but custom QCs are more efficient and cost-effective. When you’re working with a partner like UTAK, we manufacture the custom controls you need in one vial with all 20 analytes.

With custom 3rd party QCs, your lab saves money through a streamlined ordering process that eliminates the waste of mixing multiple levels of materials. Better still, you reduce the possibility of additional errors during testing by combining materials from separate vials.

2. Compliance: Satisfy Strict Regulatory Standards 

Your testing lab needs to meet — and exceed — standards required by the regulatory bodies designated to protect patient safety. Whether your team needs to conform with guidelines set by CAP, SAMHSA, ASCLD, CLIA, FDA, CMS, CLSI, or other organizations, you need to protect your lab’s accreditation status to remain in operation.

Manufacturer-supplied controls are “dependent” QCs, which means they are created to align with their specific test systems. In addition, these controls are often made from the same raw materials as the manufacturer’s reagents and calibrators. Your lab has no way to identify any potential instrument errors, matrix-bias effects, or changes to reagents by the manufacturer.

These vulnerabilities throw your ability to maintain compliance into question. To protect your accreditation status, your QC program should allow for peer inspections, audits, and other routine elements that are best practices for testing labs.

With independent, 100% REAL™ 3rd party QCs, you protect your results by not using materials optimized to perform with a single test system or instrument. Instead, your QC material closely reflects your patient samples, which enables you to better detect analytic errors and maintain the compliance you need.

3. Confidence: Limit Outside Variables and Trust Your Results

Opting for QC materials from instrument manufacturers sacrifices control over a key element of your testing process. For example, if the manufacturer made an error in their calibrations, that same error could be applied to their QC materials. And your lab would have no idea that a problem exists before using these materials in testing.

Failure of quality control testing can be attributed to errors that are clerical, technical, methodological, systemic — or simply random. But unexpected variabilities and deviations in your testing will destroy your ability to be confident in your lab’s results.

You need to protect the integrity of your QC samples to ensure your findings are trustworthy. With 3rd party quality controls, you can better detect errors in your test system and remain confident that your results are precise and accurate.

What’s in Your Pipet? Your Lab Needs Independent 3rd Party QC

Your diagnostic testing is designed to answer questions about the presence and levels of specific substances. But with substandard QCs, you never get clear data. As a laboratory, you need to answer for the specifics behind your testing materials to satisfy regulatory requirements and, ultimately, ensure the accuracy of your results.

Is your quality control material made from 100% REAL™ human matrices? Is it available in the quantities and conditions your lab needs? Does your QC have a long shelf life? Are its contents consistent from lot to lot? Does it contain the multi-analyte panels in clinically relevant concentrations?

The right 3rd party QC provider will answer “yes” to all these questions. At UTAK, we give you the option to send our products to 3rd party labs to verify our values prior to release. More customers base their expected results off our verified values than our target values because the figures stem from one of their competitors and vets their expected findings.Your lab doesn’t just need independent, 3rd party QC. You need materials provided by a Control Freak™ who will enable your lab to take control of its testing. If you need a custom tailored solution to verify the precision of your results, we should talk.