Common Reasons for the Handling of Exceptions in the Lab

Assay Interferences are a common problem in the laboratory, creating a disconnect between the test result and the clinical reality. This forces the lab to investigate, to handle samples as exceptions, which interrupts the workflow and creates a delay in the test result.

Impact for the patient

Up to 5% of Clinical Laboratory test results are potentially affected as a result of the common interferences.*

Assay design plays a critical role in enabling the correct diagnosis and corresponding treatment path. VITROS® Solutions offer safety technologies to minimize these problems, increasing efficiency and quality of laboratory test results as well as Turn around Time, which is crucially important for critically ill patients.

Learn here how this is being addressed for 5 common challenges:

Electrolyte Exclusion Effect

How to assure the right result for electrolytes also at abnormal levels of proteins/lipids?

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The Challenge

Electrolyte Exclusion Effect with Indirect ISE

With Indirect ISE, Samples are diluted. Samples with increased fraction of solid phase result in a more dilute liquid phase and the concentration of electrolyte is underestimated.

Samples with increased fraction of solid phase result in a more dilute liquid phase and the concentration of electrolyte is underestimated.

Potential misclassification leading to incorrect patient management of critical care patients.

The VITROS® Solution

VITROS® MicroSlides for NA, K+, CL-

  • Single-use DIRECT Ion specific electrode (ISE)
  • No dilution of the sample
  • No Electrolyte Exclusion Effect

Other advantages:

  • One set of electrodes per test
  • No electrode maintenance

Ortho Microslides layers and structure

Hemolysis, Icterus, Lipemia

How to avoid falsely reported results due to Hemolysis, Icterus or Lipemia (HIL)

The Challenge

HIL is a common challenge and can contribute to poor laboratory results

 

% OF SAMPLES WITH HIL
(average based on multiple references*)

6%
Hemolysis

7.6%
Icterus

7.4%
Lipemia

The VITROS® Solution

VITROS® MicroSlide

Spreading layer filters out the potentially interfering hemoglobine, bilirubines or lipids for chemistry assays.

VITROS® MicroSensor Technology

Flags results in case of endogenous interferences for homo- and heterogenous immunoassays with:

  • No Additional sample, reagent or consumable
  • No Impact on TAT

Microsensor technology

Paraproteins

How To Avoid Falsely Elevated Or Decreased Results On A Variety Of Assays Due To Paraproteins.

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The Challenge

Paraproteinemia occurs in a variety of conditions, including multiple myeloma, Waldenström’s macroglobulinaemia, plasmacytoma, amyloidosis, and monoclonal gammopathy of undetermined significance (MGUS).

The overall prevalence of paraproteinemia has not been rigorously studied; however, the prevalence of MGUS, the most common cause of paraproteinemia, is approximately 3-4% in individuals > 50 years old and 6-8% for those individuals >80 years old. 1

Paraproteins present in serum can interfere in a variety of ways with a number of laboratory assays, leading to a range of incorrect laboratory results.

The VITROS® Solution

VITROS® MicroSlide Spreading layer filters out the potentially interfering proteins

Microsensor technology

Water impurities

How To Avoid Erroneous Results Due To Bad Water Quality?

The Challenge

Many impurities can be present in water, which may interfere with testing and lead to inaccurate results.2

The table below provides an overview of the different contaminants that can impact laboratory applications.3

IONS ORGANICS BACTERIA BACTERIA by-products PARTICLES SILICA
General Chemistry x x
Enzymes x x x x
Toxicology TDM x x x
EIA x x x x
Trace Elements x x x x
Molecular Testing x x x x
Diagnostic Instruments x x x x x x

The VITROS® Solution

VITROS® dry chemistry uses no water

  • No effluent to sample, test, treat or discard
  • No plumbing
  • No drains

Ortho instruments need no plumbing

Carry over and bubble & clot errors

How To Avoid Errors Due to Bubbles and Clots and Avoid Carry Over?

The Challenge

Carry Over may happen due to the use of the probes for samples and reagents.

 

Bubbles and clots may be undetected and create errors.

The VITROS® Solution

VITROS® SMART Metering accurately dispenses samples and avoids carry over due to disposable tips:

Patented Pressure Level-Sensing technology for bubble and clot detection.

VITROS® SMART Metering dispenses sample accurately

Find out more about Ortho Solutions:

VITROS® Assay Menu

VITROS® Automation Solution

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References

  1. Prevalence of Monoclonal Gammopathy of Undetermined Significance: A Systematic Review - Rishi K. Wadhera, MPhil, and S. Vincent Rajkumar, MD - Mayo Clin Proc. • October 2010;85(10):933-942 • doi:10.4065/mcp.2010.0337 • https://www.mayoclinicproceedings.org/
  2. Review of The Impact of Water Quality on Reliable Laboratory Testing and Correlation with purification Techniques - Rana Nabulsi, PhD, MSc, BSc, CPHQ,1 Mousa A. Al-Abbadi, MD, FIAC, CPHQ2* - Lab Med Fall 2014;45:e159-e165 - DOI: 10.1309/LMLXND0WNRJJ6U7X
  3. Lit. No. PB1742ENUS. 01/12., EMD Millipore Corporation, Billerica, MA, U.S.A.-
  • * Data on file PR-05255.

PR-06071