Establishment Of The Reference Serum System About HBV Markers And Comparison Of The Diagnositic Effect Between Six Kinds Of Domestic HBV Kits

Objective:Establish standard reference serum system and series of concentration standard preparation about HBV markers; use them as gold standard to evaluate HBV Kit's diagnostic effect. Compare and evaluate six domestic HBV kits'on HBsAg, anti-HBs and anti-HBc diagnoses.Methods:Parallel detection of 155 pouches of dumped blood plasma from Beijing Red Cross Blood Center by using Abbott kits twice and acknowledge its consistency and dependablity. Estimate the reference serum sample size, analysis and judge whether the reference serum system can be regarded as gold standard to evaluate HBV kits. According to Abbott MEIA kits'diagnostic results, we select one control serum from every item and regard its concentration as one unit, dilute this control serum into a series of concentration standard preparation. Each concentration standard preparation was detected ten times by Abbott MEIA kits, acknowledges its stability, linear relationship and dilute rationality.Every reference serum and series concentration standard were detected respectively with selected five EIA kits and one RIA kits used frequently on HBsAg, anti-HBs and anti-HBc diagnoses in China. The results came from Abbott kits were regarded as"gold standard", compare and evaluate theirs'diagnostic effect from validity, reliability, consistency with gold standard, R2 of linear relationship and the minimum detection limit.Results: The two detection results show the average CVs of HBsAg-S/N, the concentration of anti-HBs, anti-HBc-CO/S and anti-HBe-CO/S are less than 8.67%, but the average CV of HBeAg-S/N is 12.99%; The consistent rate of each item in two detections is more than 99.35% and the Kappa value is higher than 0.97. The statistic test shows the two detection results are coincidence (P<0.01). Using Abbott MEIA kits to detect standard preparations ten times on HBsAg, anti-HBs and HBeAg, which shows the CV of each concentration is less than 7.81%; and only little concentration's CV on anti-HBc and anti-HBe diagnoses is above 10%. The R2 of curve fitting about HBsAg, anti-HBs and HBeAg standard preparations is more than 0.99, the R2 of curve fitting about anti-HBc and anti-HBe standard preparations is above 0.96.The results came from detecting standard preparations by using Abbott MEIA kits can be regarded as hypothetic gold standard. The results of detecting HBsAg, the sensibility of Huamei and Kehua kits is less than 90.00%; the results of detecting anti-HBs, the specificity of Kehua kit is 82.96%; the results of detecting anti-HBc, the specificity of Huamei kit is 87.37%; other items'sensibilities and specificities come from six brands are above 90.00%. The Youden's index of six brands'each item is between 0.80 and 0.97. The Kappa value of the HBsAg came from Huamei kit is 0.80; The Kappa value of the anti-HBs came from Kehua kit is 0.73; the other Kappa values of six brands'every item is more than 0.83.Among five brands of EIA kits, the HBsAg CV between the reaction plates of Huamei, Wantai and Rongsheng kits exceed 20%; the anti-HBs CV between the reaction plates of Huamei is 83.98%, and anti-HBc CV is 22.36%; the other CVs within the reaction plates of six brands'every item are less than 15%, the other CVs between the reaction plate are less than 20%. All of the six brands'HBsAg, anti-HBs and anti-HBc R2 of curve fitting are more than 0.96, most of them exceed 0.99. The minimum detectable concentrations in all items came from Beifang kits. The minimum detection limit of HBsAg, anti-HBs and anti-HBc are respectively 1:50, 2.2 mIU/ml and 1:2326.Conclusions: The reference serum system and series concentration standard preparation were detected by using Abbott kits, it can be found that the stability is good and the result is dependable, so the detective results can be regarded as gold standard for evaluating other HBV kits. The sample sizes of the negative and positive specimen about HBsAg, anti-HBs, anti-HBc and anti-HBe items are valid, and the reference serum system can be used for sequent appraising. HBeAg item is rejected from the reference serum system because its sample size is insufficient. All other series of concentration standard preparations can be used for sequent appraising because reasonably diluted.The detective results of six brands on HBsAg, anti-HBs and anti-HBc coincide with the respective hypothetic gold standard, and they are true and dependable. The distinction on diagnostic effect among the five brands of kits is not conspicuous. Some kits'CV between the reaction plates is larger, so Kits should be used cautiously to avoid incorrect conclusion made out. The effect of curve fitting on every standard preparation is good, The minimum detectable concentration of Beifang RIA kits is the lowest in three items.