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January 14, 2026

False positives in transfusion-transmitted infection proficiency testing due to matrix effects in external quality assessment samples: lessons for clinical laboratories

Key Points

This research aims to address matrix-related interference in proficiency testing samples for transfusion-transmitted infections.
Analyzed blinded samples using various assays including CMIA, ELFA, and VITROS 3600.
Conducted reflex testing with immunochromatographic tests, nucleic acid testing, and neutralization assays.
Implemented a structured root cause analysis and performance assessment methodology.
Consistent low reactivity noted in CMIA with unusual patterns.
Other assays showed varied results, with some nonreactive findings.
Matrix interference attributed to stabilizers, stressing the need for quality assurance measures.

Abstract

Abstract Introduction Proficiency testing, a cornerstone of external quality assessment, benchmarks laboratory performance and detects systematic errors. Although extremely rare, matrix-related interference in proficiency testing samples can produce misleading results across platforms, highlighting the importance of sample commutability. Methods During a proficiency testing cycle for transfusion-transmitted infections, a blood center observed uniform low hepatitis B surface antigen reactivity in 5 blinded samples on the Alinity i chemiluminescent microparticle immunoassay (CMIA) platform (Abbott). This consistent yet unusual reactivity prompted further investigation. Cross-validation using the Roche Elecsys-e411 analyzer, Abbott ARCHITECT i1000SR analyzer, and the bioMérieux VIDAS enzyme-linked fluorescent assay (ELFA) showed similar results, whereas the QuidelOrtho VITROS 3600 chemiluminescence immunoassay reported 4 nonreactive results and 1 invalid result. Reflex testing on rapid immunochromatographic tests, nucleic acid testing (NAT), and neutralization assays was performed. A reflex testing protocol that integrated orthogonal methodologies, root cause analysis, and corrective maintenance were employed to systematically investigate discordance. Results The CMIA consistently showed low reactivity; the ELFA was borderline; and the VITROS 3600, rapid tests, and NAT were nonreactive. Neutralization assays confirmed nonspecific signals. Instrument issues were excluded. The external quality assessment provider attributed these findings to matrix interference, likely from stabilizers. Performance assessment used a peer group methodology. Discussion Matrix interference in proficiency testing, although rare, can compromise interpretation. Reflex testing, structured root cause analysis, robust standard operating procedures, staff training, and attention to sample commutability are essential to strengthen quality assurance.

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