Journal of clinical pathology · 2026
Developing a national proficiency testing programme for biospecimens: the Thailand Biobank Consortium experience.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Apisampinvong Piyavat, Wongkasa Chawanit, Thanomchard Thanastha, Denchairat Natthanich, Luepongpatthana Natthaorn, Kamngoen Ratikorn, Bissanum Rassanee, Khongkow Pasarat, Judprasong Kunchit, Suvagandha Dhitiwass, Pasena Arnat, Jinawath Natini
Аннотация
AIMS: To address the absence of nationally accessible proficiency testing (PT) for biospecimens in Thailand, we developed and evaluated a pilot PT programme consisting of four schemes covering DNA extraction, quantification, purity and integrity assessment.
METHODS: The pilot PT programme comprised two processing schemes: DNA extraction from whole blood (P-DNABLD) and frozen tissue (P-DNAFRT) and two testing schemes: DNA quantification and purity (T-DNAQ) and DNA integrity (T-DNAI). All schemes were conducted in accordance with ISO/IEC 17043:2023 and ISO 13528:2022. PT items were assessed for homogeneity and stability, and participant performance was evaluated based on consensus values using z- or z'-scores.
RESULTS: All PT items satisfied the ISO 13528:2022 requirements for homogeneity and stability after accounting for instability-related uncertainty in T-DNAQ. 30 laboratories participated nationwide in at least one scheme (P-DNABLD, n=28; P-DNAFRT, n=17; T-DNAQ, n=29; T-DNAI, n=13). All PT items were received within 3 days of dispatch, with ≥90% arriving within the acceptable temperature range. DNA extraction yield-related measurands demonstrated substantial interlaboratory variability (CV 78.2‒95.3%), whereas purity and integrity measurands were more consistent (CV 1.3‒11.2%). In T-DNAQ, A260/A230 showed the greatest interlaboratory variability (CV 8.2‒16.4%); within-platform variability was low in T-DNAI. Across all schemes, ≥75% of participants achieved at least Satisfactory performance (|z or z'| ≤ 2.0). Direct costs were approximately 12% of those of comparable international PT schemes.
CONCLUSIONS: This pilot demonstrates the feasibility and accessibility of a nationally coordinated PT programme for biospecimens and supports the establishment of a sustainable PT framework to harmonise biospecimen quality practices.
METHODS: The pilot PT programme comprised two processing schemes: DNA extraction from whole blood (P-DNABLD) and frozen tissue (P-DNAFRT) and two testing schemes: DNA quantification and purity (T-DNAQ) and DNA integrity (T-DNAI). All schemes were conducted in accordance with ISO/IEC 17043:2023 and ISO 13528:2022. PT items were assessed for homogeneity and stability, and participant performance was evaluated based on consensus values using z- or z'-scores.
RESULTS: All PT items satisfied the ISO 13528:2022 requirements for homogeneity and stability after accounting for instability-related uncertainty in T-DNAQ. 30 laboratories participated nationwide in at least one scheme (P-DNABLD, n=28; P-DNAFRT, n=17; T-DNAQ, n=29; T-DNAI, n=13). All PT items were received within 3 days of dispatch, with ≥90% arriving within the acceptable temperature range. DNA extraction yield-related measurands demonstrated substantial interlaboratory variability (CV 78.2‒95.3%), whereas purity and integrity measurands were more consistent (CV 1.3‒11.2%). In T-DNAQ, A260/A230 showed the greatest interlaboratory variability (CV 8.2‒16.4%); within-platform variability was low in T-DNAI. Across all schemes, ≥75% of participants achieved at least Satisfactory performance (|z or z'| ≤ 2.0). Direct costs were approximately 12% of those of comparable international PT schemes.
CONCLUSIONS: This pilot demonstrates the feasibility and accessibility of a nationally coordinated PT programme for biospecimens and supports the establishment of a sustainable PT framework to harmonise biospecimen quality practices.