Continued provision of WHO International Standards for total and free PSA: Content and commutability of replacement preparations.
Clin Biochem
; 71: 58-66, 2019 Sep.
Article
em En
| MEDLINE
| ID: mdl-31295477
ABSTRACT
OBJECTIVES:
Replacements are required for the WHO International Standards (IS) for free PSA, coded 96/668 and total PSA (9010), coded 96/670, which were established in 1999 to support efforts to harmonise PSA assays and address non-equimolarity. An important consideration is that the introduction of the replacements should have minimal impact on PSA measurements. DESIGN ANDMETHODS:
We report the development of a replacement strategy, informed by field assessment of preparations through an external quality assessment scheme and the subsequent evaluation of the candidate ISs in worldwide collaborative studies.RESULTS:
By immunoassay, data from participants confirmed the value assigned to the current standards. Robust geometric mean estimates of the free PSA content of the candidate replacement for 96/668 coded 17/102 was 0.533⯵g/ampoule (nâ¯=â¯21). The ratio of the content estimates of 17/10296/668 was 0.516 (GCV 12.5%, nâ¯=â¯21). Robust geometric mean estimates of the total PSA content of the candidate replacement for 96/670, coded 17/100, was 0.505⯵g/ampoule (nâ¯=â¯22). The ratio of the content estimates of 17/10096/670 was 0.490 (GCV 5.3%, nâ¯=â¯22). Through concomitant measurement of a panel of 15 representative patient samples, the candidate ISs were shown to exhibit commutability with patient samples that was comparable with that of the current ISs.CONCLUSION:
On the basis of these results, the preparations coded 17/102 and 17/100 were established by the WHO Expert Committee on Biological Standardization as the 2nd ISs for free and total PSA (PSA-ACT+free PSA) respectively, with assigned contents of 0.53⯵g/ampoule and 0.50⯵g/ampoule.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
2_ODS3
Base de dados:
MEDLINE
Assunto principal:
Antígeno Prostático Específico
Limite:
Humans
Idioma:
En
Revista:
Clin Biochem
Ano de publicação:
2019
Tipo de documento:
Article