Abstract:Abstract: ObjectiveTo prepare quality control products with stable performance, good homogeneity, and wide applicability,which contain the wild-type (CC),mutant (TT) and heterozygous (CT) sites of methylenetetrahydrofolate reductase (MTHFR) 677 locus, respectively,andevaluatetheir perfomance.Theywillprovidebases for theinter-laboratoryqualityevaluationofMTHFR677genetes-ting and evaluating the testing capability of MTHFR 677 gene and existing problems of participating laboratories. MethodsThe DNA samples respectively containing wild (CC), mutant (TT) and heterozygous(CT) types of MTHFR 677 locus were screened from 200 clinicalsaofaolawusaagrsitcbatalah neity and stability in CNAS-GLO3"Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing", the homogeneity and stability of the screened samples were verified. The DNA samples passing the verification of homogeneity and sta-bility were diluted to a concentration of 30 ng/ pL and divided into 30 pI/tube as quality control products for the wild, mutant, and heterozygoustypesofMTHFR677locusrespectively.Fiveblindqualitycontrolsamplescoveringvariouscombinationsof3kindsof genotypes of MTHFR 677 locus were prepared and distributed to six public hospitals that had already performed folate testing.The quality of the five blind quality control samples was verified by the testing methods and reagents used by each hospital. ResultsThe DNA samples respectively containing wild (CC),mutant(TT) and heterozygous (CT) types of MTHFR 677 locus were successfully screened out from the wholeblood DNAextracted from theclinicalsamples of anticoagulant wholebloodby the Sanger sequencing.The verification of real-time fluorescence quantitative PCR for the homogeneity and stability of the prepared quality control products showed that their genotypes of MTHFR 677 locus were consistent with the expected genotypes(10o%).The accuracy rats of the detection re- sults for 5 blindquality control samples in six public hospitals wereall 100%.ConclusionThepreparedquality control products for MTHFR 677 C/Tgene testing in this study have good homogeneity,stability,and applicability,providing experimental basis for the preparation ofquality control products for thegene detection of MTHFR677locususing the clinicalsamples of human anticoagulant whole blood.