High proficiency in detecting the six major hepatitis C virus genotypes of laboratories involved in testing plasma by nucleic acid amplification technology.
Since the introduction of mandatory HCV RNA testing of plasma pools for fractionation by nucleic acid amplification technology, we have organised External Quality Assessment studies (EQAs) addressed to blood products manufacturers and blood centres. Here we report the results of a new EQA, the first one to include all six major HCV genotypes. The results, reported by laboratories worldwide, showed that genotypes 1, 2 and 3 were correctly identified in 100% of the tests, genotype 4 in 96.7% and genotypes 5 and 6 in 98.3% of the assays. As detection of all HCV genotypes is critical for laboratories involved in testing plasma for HCV, all six genotypes should continue to be included in the next EQA studies.
Gentili
G
G
Laboratory of Immunology, Istituto Superiore di Sanità, Rome, Italy. ggentili@iss.it
Pisani
G
G
Saldanha
J
J
Cristiano
K
K
Wirz
M
M
Bisso
G M
GM
Mele
C
C
D001803:Blood Transfusion / Q000592:standards; D003951:Diagnostic Errors; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics* / Q000302:isolation & purification; D006526:Hepatitis C / Q000175:diagnosis / Q000517:prevention & control / Q000635:transmission; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D015588:Observer Variation; D010949:Plasma / Q000821:virology*; D011785:Quality Assurance, Health Care