Six problems with urinalysis controls

October 14, 2019

Running daily quality control for your urine analyzer is intended to identify any problems that could impact the instrument’s ability to accurately detect parameters in a patient sample. The urinalysis control’s purpose is to prove readiness and alert your technicians about the need to service that instrument in order to preserve the accuracy of diagnostic interpretations made from that urine analyzer’s readings.

When treatment is dependent on the proper diagnosis and monitoring of problems like inflammation, infection, cancer, and trauma, it is imperative to do more than trust the instrument.

With critical patient outcomes, clinical reputation, and laboratory accreditation on the line when using automated urine analysis instrumentation, you want to be sure that any results relayed back to doctors and patients are accurate. When treatment is dependent on the proper diagnosis and monitoring of problems like inflammation, infection, cancer, and trauma, it is imperative to do more than trust the instrument. The use of quality control materials in clinical laboratories is required for point-of-care testing, as mandated by the Clinical Laboratory Improvement Amendments (CLIA). While all urinalysis controls are designed to meet the minimum requirements of the law per regulations outlined by CLIA, not all commercially available QC materials are made to the same standard.

Here are the 6 biggest problems that exist with many commercially available urinalysis controls:

6. Preparation time

Many urinalysis controls require hydration prior to usage. This time-consuming step provides a benefit to the manufacturer- it may reduce costs and artificially extend an unstable shelf life – but it’s inconvenient for the technician and can end up costing the laboratory time and resources. Improper handling, like pre-dilution, can also lead to erroneous results or costly unnecessary service calls.

5. Non-cellular materials

Your lab’s urinalysis instruments are finely tuned to detect and classify cellular materials across wide biological variation. Each target of interest can lead to different medically relevant indications. Each input parameter may also be processed differently by urinalysis instrumentation. This means that an individual bacterium in an infection is enumerated differently than other cellular material. Latex simulacrum may mask faults and may not reflect errors in instrumentation that require cellular material for detection, such as missing dye components or ineffective lytic reagent packages. Many commercially available controls use size-specific, manufactured latex beads in place of real, cellular materials to lower costs and extend shelf-life — at the expense of testing patient-like materials.

“For a control to fully evaluate the capabilities of the instrument, it should challenge the instrument.”

4. Limited control mode

For a control to fully evaluate the capabilities of the instrument, it should challenge the instrument. Pre-stained controls run in control mode may skip entire critical elements of the analysis pathway, while urinalysis controls designed to be run in patient mode represent how the instrument examines a real patient sample.

3. A free pass

Many controls are not designed to challenge the instrument, but instead prioritize shelf life and are made, simply, to pass. We know controls are required, but controls are much more than a “necessary evil.” A control helps you identify issues with instrumentation early, saving re-runs, preventing inaccurate reporting, and limiting downtime. Quality control materials should test every aspect of evaluating a patient sample to validate instrument performance and ensure accurate results.

Quality control materials should test every aspect of evaluating a patient sample to validate instrument performance and ensure accurate results.

2. Availability problems

Some manufacturers place low priority on controls, so the availability of urine analyzer controls may fluctuate. For a reliable control, that sample should demonstrate consistent availability over several years and maintain a spotless product delivery record over that time.

1. Missing critical targets

Your urine analyzer is designed to detect more sediment parameters than simply white blood cells and red blood cells; unfortunately, many commercially available urinalysis controls do not test for all parameters reported by your instrument. Some of the ones that you use to test your instrument’s ability to identify these urine components are made of 100% imitation cellular material instead of any biological material.

“If your QC methods are only ‘checking the box,’ you might be missing critical insight into the true condition of your patient-critical instrument.”

UA-Cellular Complete Urinalysis control contains cellular components

Streck’s UA-Cellular® Complete contains both chemistry analytes and cellular components to more closely mimic a patient sample. Controls are meant to put you in control. Their use is critical in ensuring the appropriate outcome for patients and maintaining the integrity of your laboratory data. When selecting a control for your urine analyzer, choose one that challenges your instrument and ensures you are getting everything you are supposed to get out of the instrument.

If your QC methods are only ‘checking the box,’ you might be missing critical insight into the true condition of your patient-critical instrument. Streck recognizes the need for high quality control materials in urinalysis testing by providing reliable urine controls with physical similarity to actual patient samples.

Our UA-Cellular Complete is a combined urinalysis chemistry and micro control designed specifically for the Siemens CLINITEK Atlas®, Sysmex® UF-1000i and the Arkray AUTION HYBRID AU-4050 integrated automated urinalysis instruments. It can be run like a patient sample and requires no oversight.

  • Ready-to-use liquid urine control that requires no hydration or dilution step
  • Contains common urine chemistry analytes and 6 urine particle types to mimic a patient sample
  • Tests the entire system’s ability to accurately identify and quantify chemistry and cellular components
UA-Cellular Complete Urinalysis control

For more information about our comprehensive urinalysis controls, click here.

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