ABSTRACT
@#ObjectiveTo establish the national reference panel for coxsackievirus A16(CA16)nucleic acid detection kit and related quality standard.MethodsThe CA16 positive and negative samples were collected and screened,and then were filled and lyophilized to establish the national reference panel for CA16 nucleic acid detection kit. According to the cooperative calibration results of various reagent manufacturers,the quality standard of reference panel was determined.Meanwhile,the homogeneity and stability of the national reference panel were well studied.ResultsThe national reference panel of CA16 nucleic acid detection kit consisted of 9 positive samples,8 negative samples,1 limit-detecting sample and1 precision sample. The quality standard was as follows:the coincidence rate of positive samples was no less than 8/9;The coincidence rate of negative samples was 8/8;The minimum detection limit required that the dilution of limit-detecting sample was no less than 1∶103;The precision required that the coefficient of variation(CV)of Ct value of 10 precision samples diluted 100 times was no higher than 5% and the results were all positive. The homogeneity of the reference panel met the requirement,and the stability was not affected by the storage at room temperature(25 ℃)for 24 hours and repeated freezing and thawing three times.ConclusionThe first national reference panel of CA16 nucleic acid detection kit and the related quality standard have been established,which provided a reference for the quality control and evaluation of the related reagents.
ABSTRACT
OBJECTIVE: To establish the reference panel of methamphetamine (MET) Kits. METHODS: After determining the cut-off value of MET kits, selecting the raw material, and determining the component of reference material, MET kits reference material was prepared. The reference material was characterized by verified LC-MS method, and also tested for the stability. RESULTS: The national reference material of MET kits consists of one positive sample, 12 negative samples, three LOD samples, and one repeatability sample. This reference material passed the co-characterization of five companies. CONCLUSION: The developed national reference material of MET kits meets the corresponding requirement. The establishment of the national reference material of MET kits may help regulate the development and production process of the drug kits.
ABSTRACT
BACKGROUND: Establishment of a national reference panel for syphilis antibodies is necessary to evaluate the performance of in-vitro diagnostic tests for syphilis and to verify test quality. This study aimed to establish a national reference panel for syphilis antibodies, to assess the suitability of a panel for non-treponemal and treponemal testing, and to assess the reactivity of the various tests currently in use. METHODS: Treponemal pallidum particle agglutination (TPPA)-positive and -negative fresh frozen plasma samples were obtained. After the fresh frozen plasma was converted to serum by defibrination, the samples were pooled. Two candidate reference standards containing no syphilis antibodies and 10 candidate reference standards containing syphilis antibodies were prepared on the basis of reactivity in the TPPA assay. Candidate reference standards were tested by three laboratories using five non-treponemal tests and four treponemal tests. RESULTS: All three laboratories reported positive non-treponemal test results for the mixed-titer performance panel (MP)/6-MP/12. MP/1, MP/2, and MP/3 were negative for non-treponemal tests. MP/4 and MP/5 were reported either as positive or negative according to the laboratories. All laboratories reported positive TPPA results for MP/3-MP/12 and negative results for MP/1 and MP/2. No significant difference was detected among the treponemal testing results in three laboratories. CONCLUSIONS: We established 12 candidate national reference standards containing various concentrations of syphilis antibodies. A collaborative study using nine tests demonstrated that 12 candidate national reference standards presented consistent results, except a few assays with low sensitivity, and thus could be used as a national reference panel for syphilis antibody testing.