Commutability of NIST SRM 1955 Homocysteine and Folate in Frozen Human Serum with selected total homocysteine immunoassays and enzymatic assays.
BACKGROUND
The National Institute of Standards and Technology (NIST) has recently developed Standard Reference Material (SRM) 1955 Homocysteine and Folate in Frozen Human Serum with certified values for total homocysteine (tHcy) and 5-methyl-tetrahydrofolic acid. NIST has performed an international, interlaboratory assessment of SRM 1955 commutability; results are reported for tHcy only.


METHODS
Total Hcy was measured in 20 patient sera and in 3 levels of SRM 1955 using 14 immunoassays and/or enzymatic assays. Liquid chromatography/tandem mass spectrometry was utilized as the reference assay. An "errors-in-variables" statistical model was utilized to assess the commutability of SRM 1955.


RESULTS
Normalized residuals ranged from -2.65 to 2.19 for SRM 1955. The median interlaboratory/interassay imprecision (CV) was approximately 4% for patient specimens and ranged from approximately 3% to approximately 7% for SRM 1955. The median intra-assay imprecision ranged from approximately 1% to approximately 13%. Orthogonal residuals, as a descriptor of assay accuracy, ranged from 0.29 to 7.71 and from 0.20 to 2.22 for patient specimens and SRM 1955 samples, respectively.


CONCLUSIONS
The current study suggests that SRM 1955 is commutable with the investigated tHcy assays; however, a broader specimen set needs to be evaluated to completely substantiate this conclusion.
Nelson
Bryant C
BC
National Institute of Standards and Technology, Biochemical Science Division, Gaithersburg, MD 20899-0001, USA. bryant.nelson@nist.gov
Pfeiffer
Christine M
CM
Zhang
Ming
M
Duewer
David L
DL
Sharpless
Katherine E
KE
Lippa
Katrice A
KA
D001774:Blood Chemical Analysis / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods; D004798:Enzymes / Q000737:chemistry*; D005492:Folic Acid / Q000097:blood*; D005615:Freezing; D006710:Homocysteine / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D016014:Linear Models; D015233:Models, Statistical; D011237:Predictive Value of Tests; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods; D013763:Tetrahydrofolates / Q000097:blood; D014481:United States
D004798:Enzymes; D013763:Tetrahydrofolates; D006710:Homocysteine; D005492:Folic Acid; C005984:5-methyltetrahydrofolate