Progress in immunoassays for serum prolactin: evidence from the UK External Quality Assessment Scheme (EQAS) 1980-1989.

The quality of serum prolactin assays routinely performed by UK laboratories has been monitored in an external quality assessment scheme (EQAS) over a 10-year period, during which participation in the EQAS increased three-fold, and considerable changes in methods and standardization were introduced. The all-laboratory mean was used as the sample target value, and proved to be stable and accurate. Overall between-laboratory agreement in the clinically important range improved from a geometric coefficient of variation (GCV) of 25% to 14%. This appears to reflect the increased use of kits in place of 'in-house' assays, the more widespread availability of international standards and the absence of any marked differences in bias between the commonly used methods. Published guidelines on the clinical interpretation of prolactin values should, therefore, be widely applicable. The EQAS data indicate that, in general, the quality of performance of prolactin assays is adequate for their clinical application.

Validation of target values in external quality assessment schemes for peptide hormones and tumour markers.

Consensus means are tacitly assumed to provide correct target values in many external quality assessment schemes EQAS for peptide hormones and tumour markers. We suggest, however, that such targets should not be used without some evidence of their validity. Comparison of the expected and found increments in the target value on adding known quantities of International Standards to serum pools can provide confirmation of the correctness of target values or, in some cases, identify clearly incorrect targets. Validation of targets is important if EQAS are to stimulate use of correctly calibrated assays, rather than those that simply agree with the most commonly used method(s).

External quality assessment of immunoassays of peptide hormones and tumour markers: principles and practice.

External quality assessment schemes (EQAS) have traditionally emphasised the achievement of between-laboratory consensus. Although this is important, the application of EQAS to relatively new and evolving techniques such as immunoassay calls for a wider and more searching remit if the goals of accurate assays, properly used, are to be achieved. This article outlines the principles of EQAS for peptide hormones and tumour markers, emphasising key aspects such as validation of target values, dependency of results on sample type, and assessment of method characteristics such as vulnerability to interfering factors. The latter are considered to be important as they can affect patient care more seriously than modest degrees of imprecision or inaccuracy. EQAS play a unique role in providing objective data on assays performed in many laboratories under routine conditions and the data they provide can guide improvement in diagnostic reagents and laboratory practice.

Serum growth hormone measurements in clinical practice: An audit of performance from the UK National External Quality Assessment scheme.

The replacement of growth hormone (GH) radioimmunoassays with a variety of more specific immunometric methods in diagnostic service laboratories has led to a worsening of between-laboratory agreement, reflecting differences in method bias. Incorrect calibration and differences in specificity are important causes of method bias, but the impact of this on interpretation is not clear. In order to maximize the diagnostic reliability of GH testing for small stature, manufacturers should carefully calibrate their methods against the appropriate GH International Standard, and should use antibodies of broadly agreed specificity. Laboratories performing GH tests should participate in a reliable External Quality Assessment (EQA) scheme and guidelines for investigation that incorporate normal GH responses should be agreed.