Immunoassay external quality assessment in Italy: HBsAg and anti-HBs tests.
The mode of operation of the CNR/Tecnostandard external quality assessment scheme for HBsAg and anti-HBs assays is outlined, and the relevant results reported. Emphasis is given to the retrospective evaluation of data in an attempt to derive a picture of the state of the art in Italian laboratories. The approaches followed for this evaluation include analysis of the rate of correct results and inspection of the relationships between analyte concentration and either the percentage of positive classifications of samples or the numerical test responses. Information is given on the "average" performance of individual kits as actually used in participants' laboratories.
Pizzocolo
G
G
Cattedra di Chimica, Università degli Studi, Brescia.
Malvano
R
R
Pilloton
E
E
Signorini
C
C
Zanetti
A
A
Albertini
A
A
D005069:Evaluation Studies as Topic; D005568:Forms and Records Control; D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000592:standards*; D007558:Italy; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012015:Reference Standards; D012680:Sensitivity and Specificity
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic