Heterophilic antibody interference in commercial immunoassays; a screening study using paired native and pre-blocked sera

2011 ◽  
Vol 49 (12) ◽  
Author(s):  
Nils Bolstad ◽  
David J. Warren ◽  
Johan Bjerner ◽  
Gunnhild Kravdal ◽  
Lutz Schwettmann ◽  
...  
Keyword(s):  
External Quality Assessment ◽  
High Titer ◽  
Antibody Fragments ◽  
Clinical Use ◽  
External Quality ◽  
Heterophilic Antibodies ◽  
Screening Study ◽  
Commercially Important ◽  
Antibody Resistance ◽  
Heterophilic Antibody

AbstractHeterophilic antibodies are still an important source of interference in immunoassays. We have conducted a screening study for interference in a panel of commercially available assays using two sera known to contain high titer Fc-reactive heterophilic antibodies.The sera were distributed to laboratories participating in the Nordic External Quality Assessment cooperation (EQANord). Duplicate samples pre-blocked with aggregated murine monoclonal MAK33 were also supplied. Discrepancies (>50%) between the results for native and blocked samples were used to classify the tested assays as susceptible to interference. A total of 170 different assay kits covering 91 analytes were tested.We found that 21 assays, covering 19 different analytes, were susceptible to interference from the heterophilic antibodies in the two sera. Many of these are clinically and commercially important assays. Some of the false results were grossly elevated and could have been detrimental to patient care in a clinical setting.Heterophilic antibodies with Fc-reactivity remain a threat. A more widespread use of antibody fragments and aggregated immunoglobulin could potentially improve the heterophilic antibody resistance of assays intended for clinical use.

Thromboplastin Related Differences in the Determination of International Normalised Ratio: A Cause for Concern?

1994 ◽  
Vol 72 (03) ◽  
pp. 426-429 ◽  
Author(s):  
S Kitchen ◽  
I D Walker ◽  
T A L Woods ◽  
F E Preston
Keyword(s):  
Patient Management ◽  
External Quality Assessment ◽  
Oral Anticoagulant Therapy ◽  
Warfarin Dosage ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
International Normalised Ratio ◽  
The Uk ◽  
The Relationship

SummaryWhen the International Normalised Ratio (INR) is used for control of oral anticoagulant therapy the same result should be obtained irrespective of the laboratory reagent used. However, in the UK National External Quality Assessment Scheme (NEQAS) for Blood Coagulation INRs determined using different reagents have been significantly different.For 18 NEQAS samples Manchester Reagent (MR) was associated with significantly lower INRs than those obtained using Diagen Activated (DA, p = 0.0004) or Instrumentation Laboratory PT-Fib HS (IL, p = 0.0001). Mean INRs for this group were 3.15, 3.61, and 3.65 for MR, DA, and IL respectively. For 61 fresh samples from warfarin-ised patients with INRs of greater than 3.0 the relationship between thromboplastins in respect of INR was similar to that observed for NEQAS data. Thus INRs obtained with MR were significantly lower than with DA or IL (p <0.0001). Mean INRs for this group were 4.01, 4.40, and 4.59 for MR, DA, and IL respectively.We conclude that the differences between INRs measured with the thromboplastins studied here are sufficiently great to influence patient management through warfarin dosage schedules, particularly in the upper therapeutic range of INR. There is clearly a need to address the issues responsible for the observed discrepancies.

scholarly journals The versatility of external quality assessment for the surveillance of laboratory and in vitro diagnostic performance: SARS-CoV-2 viral genome detection in Austria

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Christoph Buchta ◽  
Jeremy V. Camp ◽  
Jovana Jovanovic ◽  
Peter Chiba ◽  
Elisabeth Puchhammer-Stöckl ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
False Negative ◽  
Positive Sample ◽  
Performance Criteria ◽  
External Quality ◽  
Assay Sensitivity ◽  
Dilution Series ◽  
Test Systems

Abstract Objectives External quality assessment (EQA) schemes provide information on individual and general analytical performance of participating laboratories and test systems. The aim of this study was to investigate the use and performance of SARS-CoV-2 virus genome detection systems in Austrian laboratories and their preparedness to face challenges associated with the pandemic. Methods Seven samples were selected to evaluate performance and estimate variability of reported results. Notably, a dilution series was included in the panel as a measure of reproducibility and sensitivity. Several performance criteria were evaluated for individual participants as well as in the cohort of all participants. Results A total of 109 laboratories participated and used 134 platforms, including 67 different combinations of extraction and PCR platforms and corresponding reagents. There were no false positives and 10 (1.2%) false negative results, including nine in the weakly positive sample (C t ∼35.9, ∼640 copies/mL). Twenty (22%) laboratories reported results of mutation detection. Twenty-five (19%) test systems included amplification of human RNA as evidence of proper sampling. The overall linearity of C t values from individual test systems for the dilution series was good, but inter-assay variability was high. Both operator-related and systematic failures appear to have caused incorrect results. Conclusions Beyond providing certification for participating laboratories, EQA provides the opportunity for participants to evaluate their performance against others so that they may improve operating procedures and test systems. Well-selected EQA samples offer additional inferences to be made about assay sensitivity and reproducibility, which have practical applications.

Harmonising EQA schemes the next frontier: challenging the status quo

2020 ◽  
Vol 58 (11) ◽  
pp. 1795-1797 ◽  
Author(s):  
Tony Badrick ◽  
Anne Stavelin
Keyword(s):  
External Quality Assessment ◽  
Reference Method ◽  
Laboratory Medicine ◽  
Status Quo ◽  
External Quality ◽  
Educational Support ◽  
Laboratory Results ◽  
The Status ◽  
Clinically Significant ◽  
Eqa Schemes

AbstractThere is a focus on standardisation and harmonisation of laboratory results to reduce the risk of misinterpretation of patient results assayed in different laboratories. External quality assessment (EQA) is critical to assess the need for harmonisation and to monitor the success of procedures to achieve harmonisation. However, EQA providers are being stretched to meet the needs of their participants with proven commutable material with reference method targets, a range of clinically significant levels of the materials, detailed and customised data analysis, and educational support. The path ahead for harmonisation of EQA schemes will require leadership from an organisation that has the support and confidence of EQA providers, like the European Organisation for External Qualily Assurance Providers in Laboratory Medicine.

scholarly journals Diagnostic Challenges on the Laboratory Detection of Lupus Anticoagulant

Biomedicines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 844
Author(s):  
Armando Tripodi
Keyword(s):  
Lupus Anticoagulant ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
State Of The Art ◽  
Diagnostic Procedures ◽  
External Quality ◽  
Glycoprotein I ◽  
Current State ◽  
Clinical Laboratories

Lupus anticoagulant (LA) is one of the three laboratory parameters (the others being antibodies to either cardiolipin or β2-glycoprotein I) which defines the rare but potentially devastating condition known as antiphospholipid syndrome (APS). Testing for LA is a challenging task for the clinical laboratory because specific tests for its detection are not available. However, proper LA detection is paramount for patients’ management, as its persistent positivity in the presence of (previous or current) thrombotic events, candidate for long term anticoagulation. Guidelines for LA detection have been established and updated over the last two decades. Implementation of these guidelines across laboratories and participation to external quality assessment schemes are required to help standardize the diagnostic procedures and help clinicians for appropriate management of APS. This article aims to review the current state of the art and the challenges that clinical laboratories incur in the detection of LA.

Commutability of possible external quality assessment materials for progesterone measurement

2021 ◽  
Vol 87 ◽  
pp. 39-45
Author(s):  
Xilian Yi ◽  
Yufei Wang ◽  
Tianjiao Zhang ◽  
Jie Zeng ◽  
Haijian Zhao ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
External Quality

Appropriateness of cholesterol and triglycerides reporting checked by External Quality Assessment programs

2003 ◽  
Vol 333 (2) ◽  
pp. 221-230 ◽  
Author(s):  
Sandra Secchiero ◽  
Laura Sciacovelli ◽  
Lorena Zardo ◽  
Mario Plebani
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
External Quality
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