Validation of Irma Cgea/crenk One Method of Evaluation of the Vitamin D at the Regional Center of Nuclear Study Laboratory of Kinshasa

Ingala P, Lepira F, Mputu L


The aim of the present study was to validate the method IRMA CGEA/CRENK for the evaluation of the vitamin D status by comparison to the commercial method DIASORIN. A blood sample was obtained from 30 volunteers with a good health state in general population (11 women and 19 men) to determine serum 25(OH) D, concentrations by all those methods. Using local laboratory cutoffs, vitamin D insufficiency and deficiency was defined as 25(OH) D values of 4-14 ng/ml and ˂ 4 ng/ml, respectively; vitamin D sufficiency as ≥15ng/ml [23]. Statistical analyses were performed using Excel 12.0 and SPSS 21 statistical software’s. Mean and standard deviation (SD), were used to evaluate the mean of vitamin D of the two methods. Student t TEST was used to compare mean of the two methods.  P value ≤ 0.05 defined the level of statistical significance. PEARSON correlation coefficient (r) was performed to evaluate the correlation between the two methods.  An r=0 means the missing of correlation: r<0 means a negative correlation; r=1 means a positive and perfect correlation; 0, 75<r<1 means a positive and strong correlation.  The concordance between IRMA CGEA/CRENK and the commercial method DIASORIN has been definite as the missing of statistic difference between the means of vitamin D with the two methods and a positive correlation between the levels of vitamin D of the two methods. The coefficient kappa was calculated for avoiding the rate of random in the concordance. The variations of the coefficient Kappa is ±1.  K= -1 means total discordance.  K=+1 means an absolute concordance. K near 0 means a mean concordance explain by random. K>0, 8 (80%) is the limit of the better concordance. No statistic difference was observed between the means of vitamin D of the method IRMA CGEA/CRENK and the commercial method DIASORIN (p=0,330).  The coefficient of correlation was: r = 0, 96. The equation of correlation was: y =1,429 + 1, 02 x (y= IRMA CGEA/CRENK, x= DIASORIN Commercial).  The coefficient kappa = 0, 85.  


Irma cgea/crenk-diasorin commercial-validation.

Full Text:



. HAS (Haute Autorité de Santé).Note de cadrage.2013

. Tshiband A, Mputu L,Tozin R, Ingala , Kiampa Solid-Phase Immuno Radio Metric Assay(IRMA) of 25-hydroxy vitamin d and displacement from serum binding proteins for Resource –Limited Settings. Journal of Biomedical Engineering and Medical Devices.2015; 1: 1..

. De la Hunty A., Wallace AM., Gibson S., Vijakalmen H., Lamberg-Allrdt C., Achwell., UK Food Standards Agency Workshop Consensus Report; the choice of method for measuring 25-hydroxyvitamin D to estimate vitamin D status for the UK National Diet and Nutrition Survey.Br J Nutr 2010; 104(4): 812-9.

. Wallace AM., Gibson S., de la HA., Lamberg-Allardt C., Ashwell M. Measurement of 25-hydroxyvitamin D in the clinical laboratory : current procedures, performance characteristics and limitations. Steroids 2010; 27 (2): 477-88.

. Ingrand J. La spectrométrie de masse et ses principales applications en biologie médicale. Immuno-analyse et biologie spécialisée.2012; 27(7):47-53

.Institute of Medicine. Ross AC., Taylor CL., Yaktine AL., Del Valle HB. Dietary reference intakes for calcium and vitamin D. Washington; National Academics Press; 2011.

. Groupe de Recherche et d’information sur les Ostéoporoses.BenhamouC-L., Souberbielle J-C., Cortet B., Fardellone P., Gauvain J-B et al. La vitamine D chez l’adulte : recommandations du GRIO. Presse Med 2011 ; 40 : 673-82.

. Tai SS., Bedner M., Phiney KW. Development of a candidate reference measurement procedure for the determination of 25-hydroxyvitaminD3 and 25-hydroxyvitamin D2 in human serum using isotope dilution liquid chromatography-tandem mass spectrometry. Anal Chem 2010; 82(5): 1942-8.

. National Institute of Standard and Technology. Standard Reference Material 972.VitaminD in Human Serum. Gaithersburg: NIST; 2009.

.Marie-Dominique Blanchin. Validation des méthodes d’analyse. Journées Qualité et Chimie 2010.Une démarche qualité au service de la chimie. Autrans-14 octobre 2010. Mdb-14 octobre 2010.

. Maunsell Z., Wright DJ., Rainbow SJ. Routine isotope-dilution liquid chromatography-tandem mass spectrometry assay for simultaneous measurement of the 25-hydroxyvitamin D2 and D3. Clin Chem. 2005; 51:1683-90.

. Saenger AK., Laha TJ., Brenner DE., Sadrzadeh SMH. Quantification of serum 25-hydroxyvitamin D2 and D3 using HLPC-tandem mass spectrometry and examination of reference intervals for diagnosis of vitamin D deficiency. Am J Clin Pathol 2006; 125: 914-20.

. Chen H., McCoy LF., Schleider RL., Pfeiffer CM. Measurement of 25-hydroxyvitamin D3 25OHD3 and 25-hyroxyvitamin D2 25OHD2 in human serum using liquid chromatography-tandem mass spectrometry and its comparison to a radioimmunoassay method. Clin Chim Acta 2008; 391:6-12.

. Knox S., Harris J., Calton L., Wallace AM. A simple automated solid-phase extraction procedure for measurement of 25-hydroxyvitamin D3 and D2 by liquid chromatography- tandem mass spectrometry. Anal Clin Biochem 2009; 46: 226-30.


  • There are currently no refbacks.




About ASRJETS | Privacy PolicyTerms & Conditions | Contact Us | DisclaimerFAQs 

ASRJETS is published by (GSSRR).