External quality assessment in molecular immunohematology: the INSTAND proficiency test program

Abstract

Background Genotyping for red blood cell (RBC), platelet and granulocyte antigens is a new tool for clinical pathology, transfusion medicine services and blood banks. Proficiency in laboratory tests can be established by external quality assessments (EQAs), which are required for clinical application in many health care systems. There are few EQAs for molecular immunohematology. Methods We analyzed the participation and pass rates in an EQA for RBC, platelet and granulocyte antigens. This EQA was distributed by INSTAND, a large non-profit provider of proficiency tests, twice per year since fall 2006 as EQA no. 235 Immunohematology A (molecular diagnostic). The coordinators defined at the outset which alleles are mandatory for detection. Results The number of participants steadily increased from 51 to 73 per proficiency by fall 2012. More than 60 institutions utilized this EQA at least once a year. Approximately 80% of them participated in RBC, 68% in platelet and 22% in granulocyte systems. With the exceptions of RHD (82%) and granulocytes (85%), pass rates exceeded 93%. While the pass rate increased for granulocyte and decreased for the ABO system, the pass rates for the other systems changed little over 6 ½ years. Conclusions The INSTAND proficiency test program was regularly used for EQA by many institutions, particularly in Central Europe. While the technical standards and pass rates in the participating laboratories were high, there has been little improvement in pass rates since 2006.

Molecular tools for investigating immunohaematology problems

“…There is no doubt that molecular testing will increasingly be implemented outside of reference laboratories by the next few years, especially since proficiency programmes are now becoming available , in addition to the ISBT molecular genotyping workshops in place since 2005 . However, the full replacement of blood group phenotyping by molecular testing is still a matter of debate , especially since the genotype is only a prediction of the phenotype and large‐scale routine DNA investigation in patients or donors may also raise some legal and ethical issues.…”

It's time to phase inRHDgenotyping for patients with a serologic weakDphenotype

“…In response to the findings of the CAP TMRC survey, AABB and CAP convened a Work Group on RHD Genotyping and charged it with developing recommendations to clarify clinical issues related to RhD typing in persons with a serologic weak D phenotype. As an initial step for formulating recommendations, the Work Group reviewed the current state of molecular science of RHD , including more than 140 publications covering background; D variants with anti‐D; molecular basis of serologic weak D phenotypes; reviews, editorials, and commentaries; technical resources; and standards and guidelines . This commentary summarizes the proceedings and recommendations of the Work Group.…”

Accuracy of Blood Group Typing in the Management and Prevention of Alloimmunization

“…Recommendations on which targets and recommended controls to use for prediction of RBC antigens have been published by international societies offering proficiency test programs such as INSTAND [93], The Consortium for Blood Group Genes (CBGG) [94], College of American Pathologists (CAP), and International Society of Blood Transfusion (ISBT) [91,92] and also by The American Association of Blood Banks (AABB) [95] whose focus is on creating guidelines for AABB accreditation aiming to certify laboratories that perform molecular testing for red cell, platelet, and neutrophil antigens.…”