SH-FORM 43: Verification and Validation of a Medical Biology Method

Flashcards covering the analytical method validation parameters, experimental results, and conformity conclusions documented in the SH-FORM 43 medical biology evaluation sheet.

SH-FORM 43

A standardized form (fiche type) used for the verification (scope A / portée A) or validation (scope B / portée B) of a medical biology method.

Repeatability (Répétabilité) Evaluation

A performance test conducted on Lyphochek N ($n = 30$) yielding a mean of $2.07$, standard deviation of $0.04$, and a coefficient of variation of $1.93\%$, which was concluded compliant (conforme) because the obtained CV was lower than the supplier CV ($2.02\%$).

Intermediate Precision (Fidélité Intermédiaire) Evaluation

A performance assessment on Lyphochek N and Lyphochek P ($n = 30$ each) concluded non-compliant (non conforme) because the obtained CVs ($20.4\%$ and $78.3\%$) exceeded the laboratory's retained CV limit of $< 2.3\%$.

Trueness (Justesse) Evaluation

An assessment performed using normalized internal quality controls (CIQ) where Level 1 was compliant ($\text{bias} = 1.36\%$ vs. limit $< 5\%$) but Level 2 was non-compliant ($\text{bias} = 7.3\%$ vs. limit $< 5\%$), preventing the adoption of the technique.

Lyphochek N

The control sample (échantillon contrôle) tested with $n = 30$ values, yielding a repeatability CV of $1.93\%$ and an intermediate precision CV of $20.4\%$.

Lyphochek P

The control sample evaluated in intermediate precision testing ($n = 30$) that produced a mean of $3.09$, standard deviation of $2.42$, and an unacceptable CV of $78.3\%$.

CIQ (Contrôle Interne de Qualité)

Normalized internal quality controls evaluated across two levels to verify method trueness against an established limit of $< 5\%$ bias.