Determination of total bilirubin in whole blood from neonates: results from a French multicenter study
-
, , , and
Abstract
Background: Jaundice is frequent in neonates and can cause severe complications, especially in premature neonates, particularly the risk of developing acute bilirubin encephalopathy. Our purpose was to verify if determination of total bilirubin (TBIL) in whole blood on an ABL™ 735 blood gas analyzer with a spectrophotometer module could provide an analytical alternative to chemical methods of TBIL measurement.
Methods: Our multicenter comparative study involved four hospital laboratories. We studied the repeatability and reproducibility of ABL 735 TBIL measurements in two control sera of medium (N1, 58.1μmol/L) and high (N2, 275.3μmol/L) TBIL levels. The same study was simultaneously conducted on four chemistry instruments (two LX 20®, one Integra 800® and one Hitachi 917®) using four Jendrassik-Grof derived methods. At one site, repeatability was performed with two adult whole-blood samples containing low and high TBIL levels (55.1 and 312.6 μmol/L).
Results: Repeatability tests provided coefficients of variation (CVs) between 0.67% and 1.86% on the ABL 735 system, vs. 0.35% and 1.96% for the chemistry instruments. Reproducibility tests for the same control sera resulted in CVs between 1.01% and 3.55% for the ABL 735 and between 0.52% and 3.65% for the chemistry instruments. Recovery for the N1 and N2 control sera was 102–120%. A correlation study of TBIL determination in whole blood vs. plasma was conducted on 473 neonatal blood samples. Correlation coefficients between whole blood and plasma TBIL ranged from 0.969 to 0.994. Passing-Bablok equations were y=1.17x+9.7 [site 1 (IP)], y=1.01x+5.6 [site 2 (JPB, MR)], and y=1.00x–20 [site 3 (AS)]. Only 10% of the results fell outside the 10% range in the bias-corrected Bland-Altman difference plot for the ABL 735 method compared to traditional laboratory methods.
Conclusions: The ABL 735 instrument is reliable for measuring TBIL in 70-μL whole blood samples from neonates. Thus, this method might allow significant blood savings in preterm neonates. Correlation with the reference method for plasma or sera must be established to ensure good follow-up of patients.
Clin Chem Lab Med 2006;44:1103–10.
References
1. Comité d'Étude du Foetus et du Nouveau-né, Société Canadienne de Pédiatrie. Un mode de prise en charge de l'hyperbilirubinémie chez les nourrissons à terme. Une déclaration conjointe avec le Collège des médecins de famille du Canada. Paediatr Child Health 1999;4:167–70 (revised in February 2001; www.cps.ca/francais/enonces/FN/fn98-02.htm).10.1093/pch/4.2.167Search in Google Scholar
2. Beck M, Schlebush H, Kau N. Transcutaneous bilirubin measurement in mature newborns [poster]. In: Clinical perspectives in transcutaneous bilirubin measurement: a compendium of studies on the BiliCheck™ Non-Invasive Bilirubin Analyzer. Norcross, GA: SpectRx, Inc., 1999.Search in Google Scholar
3. Ahlfors CE. Criteria for exchange transfusion in jaundiced newborns. Pediatrics 1994; 93:488–94.10.1542/peds.93.3.488Search in Google Scholar
4. Stevenson DK, Wong RJ, Vreman HJ. Reduction in hospital readmission rates for hyperbilirubinemia is associated with use of transcutaneous bilirubin measurements. Clin Chem 2005; 51:481–2.10.1373/clinchem.2004.046789Search in Google Scholar
5. Petersen JR, Okorodudu AO, Mohammad AA, Fernando A, Shattuck KE. Association of transcutaneous bilirubin testing in hospital with decreased readmission rate for hyperbilirubinemia. Clin Chem 2005; 51:540–4.10.1373/clinchem.2004.037804Search in Google Scholar
6. Office Canadien de Coordination de l'Évaluation des Technologies de la Santé (OCCETS). La bilirubinométrie transcutanée néonatale par technique de la réflectance spectrale: un nouvel appareil. Ottowa: OCCETS, 2002 (www.ccohta.ca).Search in Google Scholar
7. Vassault A, Grafmeyer D, De Graeve J, Cohen R, Beaudonnet A, Bienvenu J. Analyses de biologie médicales: spécifications et normes d'acceptabilitéà l'usage de la validation de techniques. Ann Biol Clin 1999; 57:685–95.Search in Google Scholar
8. Vogl TP. Phototherapy of neonatal hyperbilirubinemia: bilirubin in unexposed areas of the skin. J Pediatr 1974; 85:707–10.10.1016/S0022-3476(74)80524-XSearch in Google Scholar
9. Krzeminski A. Why correct for fetal hemoglobin in blood oximetry measurements? Radiometer publication information. Copenhagen: Radiometer Medical A/S, 1992.Search in Google Scholar
10. Jendrassik L, Grof P. Vereinfachte photometrische Methoden zur Bestimmung des Blutbilirubins. Biochem Z 1938;297:81–9.Search in Google Scholar
11. National Institute of Standards and Technology. Certificate of analysis, Standard Reference Material 916a, bilirubin. Gaithersburg, MD: NIST, 2001.Search in Google Scholar
12. Bablok W, Passing H, Bender R, Schneider B. A general regression procedure for method transformation. J Clin Chem Clin Biochem 1988; 26:783–90.Search in Google Scholar
13. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1:307–10.Search in Google Scholar
14. Rota M, Borgard JP. Innovation dans l'analyse des gaz du sang: dosage de la bilirubine sur sang total, premiers essais au Centre Hospitalier Intercommunal de Créteil. In: XXVIII Colloque National des Biologistes des Hôpitaux, Colmar 1999. OptionBio Cahiers Thématiques 1999; 237(Suppl):D07.10.1016/S0338-9898(99)80334-5Search in Google Scholar
15. Borgard JP, Szymanowicz A, Adjidé V, Miled R, Pellae I, Rota M, et al. Étude multicentrique du dosage de la bilirubine sur sang total. Résultats partiels. In: XXXII Colloque National des Biologistes des Hôpitaux [poster], La Baule 2003. OptionBio Cahiers Thématiques 2003; 316(Suppl):B11.Search in Google Scholar
16. Peake M, Mazzachi B, Fudge A, Bais R. Bilirubin measured on a blood gas analyzer: a suitable alternative for near-patient assessment of neonatal jaundice? Ann Clin Biochem 2001; 38:533–40.10.1177/000456320103800511Search in Google Scholar
17. Rolinski B. La bilirubine, paramètre majeur en néonatologie est disponible sur le système Roche Omnis. J Info Biomed 2004; 70:33–5.Search in Google Scholar
18. Rolinski B, Okorodudu AO, Kost G, Roser M, Wu J, Goerlach-Graw A, et al. Evaluation of total bilirubin determination in neonatal whole-blood samples by multiwavelength photometry on the Roche OMNI S point-of-care analyzer. Point of Care 2005; 4:3–8.10.1097/01.poc.0000157097.59514.62Search in Google Scholar
19. Rolinski B. Dosage de la bilirubine en néonatalogie avec les gaz du sang. In: 3ième Symposium International Gazométrie Sanguine Biocapteurs et Méthodes Optiques, Saint-Malo, France, May 26–27, 2005.Search in Google Scholar
20. Rolinski B, Küster H, Ugele B, Gruber R, Horn K. Total bilirubin measured by photometry on a blood gas analyzer: potential for use in neonatal testing at the point of care. Clin Chem 2001; 4:1845–7.10.1093/clinchem/47.10.1845Search in Google Scholar
21. Laterza OF, Smith CH, Wilhite TR, Landt M. Accurate direct spectrophotometric bilirubin measurement combined with blood gas analysis. Clin Chim Acta 2002; 323:115–52.10.1016/S0009-8981(02)00178-XSearch in Google Scholar
22. Peake M, Mazzachi B, Fudge A, Bais R. Spectrophotometric bilirubin measurement combined with blood gas analysis [letter]. Clin Chem Acta 2003; 329:151–2.10.1016/S0009-8981(02)00425-4Search in Google Scholar
23. Suen WW, Ridley B, Blakney G, Higgins TN. Comparison of lactate, bilirubin and hemoglobin F concentrations obtained by the ABL 700 series blood gas analyzers with laboratory methods. Clin Biochem 2003; 36:103–7.10.1016/S0009-9120(02)00449-6Search in Google Scholar
24. Kohse KP, Carl A. Monitoring of bilirubin in whole blood of newborns with the blood gas analyzer ABL 735 as compared to direct spectrophotometric determinations [poster]. Clin Chem 2002; 48:A187.Search in Google Scholar
25. Arey ME, Feld GF. Evaluation of a spectrophotometric total bilirubin procedure on the Radiometer ABL 735 Multipro-Profile blood gas analyzer [poster]. Clin Chem 2002; 48:A152.Search in Google Scholar
26. Borgard JP, Szymanowicz A, Adjidé V, Miled R, Pellae I, Rota M, et al. Étude multicentrique du dosage de la bilirubine sur sang total: résultats définitifs. In: XXXIII Colloque National des Biologistes des Hôpitaux, Pau 2004. OptionBio Cahiers Thématiques 2004; 334(Suppl):B05.Search in Google Scholar
27. Résultats du contrôle de qualité hebdomadaire. ProBioQual, www.probioqual.com.Search in Google Scholar
28. Stanley FL, Doumas BT, Ashwood ER. Performance of bilirubin determinations in US laboratories – revisited. Clin Chem 2004; 50:190–4.10.1373/clinchem.2003.019216Search in Google Scholar PubMed
29. Stanley FL, Doumas BT, Ashwood ER. Bilirubin proficiency testing using specimens containing unconjugated bilirubin and human serum: results of a College of American Pathologists study. Arch Pathol Lab Med 2004; 128:1219–23.10.5858/2004-128-1219-BPTUSCSearch in Google Scholar PubMed
©2006 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Point-of-care testing – can we move from anecdote to evidence?
- A long and winding road: defining the biological role and clinical importance of paraoxonases
- Point-of-care testing in the cardiovascular operating theatre
- Low-density lipoprotein receptor-related protein 5 and vitamin D receptor gene polymorphisms in relation to vitamin D levels in menopause
- The methylenetetrahydrofolate reductase C677T gene mutation is associated with hyperhomocysteinemia, cardiovascular disease and plasma B-type natriuretic peptide levels in Korea
- Exploring allelic imbalance within paraffin-embedded tumor biopsies using pyrosequencing technology
- Detection of circulating tumour cells in blood by quantitative real-time RT-PCR: effect of pre-analytical time
- Hereditary hyper-ACE-emia due to the Pro1199Leu mutation of somatic ACE as a potential pitfall in diagnosis: a first family outside Europe
- Molecular assay for detection of the common carnitine palmitoyltransferase 1A 1436(C>T) mutation
- Serum cytokine levels and the expression of estrogen and progesterone receptors in breast cancer patients
- Protein Z levels and prognosis in patients with acute coronary syndromes
- Determination of total bilirubin in whole blood from neonates: results from a French multicenter study
- Analysis of protein S-100B in serum: a methodological study
- Lipid peroxidation and homocysteine levels in Behçet's disease
- Lower expression of the α2,3-sialylated fibronectin glycoform and appearance of the asialo-fibronectin glycoform are associated with high concentrations of fibronectin in human seminal plasma with abnormal semen parameters
- Automated processing of whole blood samples for the determination of immunosuppressants by liquid chromatography tandem-mass spectrometry
- Role of methionine residues of albumin in T-R conversion of hemoglobin
- Rheumatoid factor interference in the determination of carbohydrate antigen 19-9 (CA 19-9)
- Significance of Elecsys® S100 immunoassay for real-time assessment of traumatic brain damage in multiple trauma patients
- IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): Scientific Division, Committee on Reference Systems for Enzymes (C-RSE): Part 8. Reference procedure for the measurement of catalytic concentration of α-amylase: [α-Amylase: 1,4-α-D-glucan 4-glucanohydrolase (AMY), EC 3.2.1.1]
- ESEAP: the national External Quality Assessment Scheme for clinical chemistry in Greece and Cyprus
- Evaluation of whole-genome amplification using multiple-displacement amplification of a limited number of cells
- Comparison of various methods for the determination of total protein in urine
- Description of examinations and their results and ISO standard 15189
- Congress of Clinical Chemistry and Laboratory Medicine, Annual Congress of the Society of Clinical Chemistry and Laboratory Medicine (DGKL) in association with The Austrian Society for Laboratory Medicine and Clinical Chemistry, The Swiss Society for Clinical Chemistry (SGKC), The German Association of Technical Assistants in Medicine (dvta), Mannheim, Germany, October 1st - 4th, 2006
- First Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC), Salzburg, October 4 – 7, 2006
Articles in the same Issue
- Point-of-care testing – can we move from anecdote to evidence?
- A long and winding road: defining the biological role and clinical importance of paraoxonases
- Point-of-care testing in the cardiovascular operating theatre
- Low-density lipoprotein receptor-related protein 5 and vitamin D receptor gene polymorphisms in relation to vitamin D levels in menopause
- The methylenetetrahydrofolate reductase C677T gene mutation is associated with hyperhomocysteinemia, cardiovascular disease and plasma B-type natriuretic peptide levels in Korea
- Exploring allelic imbalance within paraffin-embedded tumor biopsies using pyrosequencing technology
- Detection of circulating tumour cells in blood by quantitative real-time RT-PCR: effect of pre-analytical time
- Hereditary hyper-ACE-emia due to the Pro1199Leu mutation of somatic ACE as a potential pitfall in diagnosis: a first family outside Europe
- Molecular assay for detection of the common carnitine palmitoyltransferase 1A 1436(C>T) mutation
- Serum cytokine levels and the expression of estrogen and progesterone receptors in breast cancer patients
- Protein Z levels and prognosis in patients with acute coronary syndromes
- Determination of total bilirubin in whole blood from neonates: results from a French multicenter study
- Analysis of protein S-100B in serum: a methodological study
- Lipid peroxidation and homocysteine levels in Behçet's disease
- Lower expression of the α2,3-sialylated fibronectin glycoform and appearance of the asialo-fibronectin glycoform are associated with high concentrations of fibronectin in human seminal plasma with abnormal semen parameters
- Automated processing of whole blood samples for the determination of immunosuppressants by liquid chromatography tandem-mass spectrometry
- Role of methionine residues of albumin in T-R conversion of hemoglobin
- Rheumatoid factor interference in the determination of carbohydrate antigen 19-9 (CA 19-9)
- Significance of Elecsys® S100 immunoassay for real-time assessment of traumatic brain damage in multiple trauma patients
- IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): Scientific Division, Committee on Reference Systems for Enzymes (C-RSE): Part 8. Reference procedure for the measurement of catalytic concentration of α-amylase: [α-Amylase: 1,4-α-D-glucan 4-glucanohydrolase (AMY), EC 3.2.1.1]
- ESEAP: the national External Quality Assessment Scheme for clinical chemistry in Greece and Cyprus
- Evaluation of whole-genome amplification using multiple-displacement amplification of a limited number of cells
- Comparison of various methods for the determination of total protein in urine
- Description of examinations and their results and ISO standard 15189
- Congress of Clinical Chemistry and Laboratory Medicine, Annual Congress of the Society of Clinical Chemistry and Laboratory Medicine (DGKL) in association with The Austrian Society for Laboratory Medicine and Clinical Chemistry, The Swiss Society for Clinical Chemistry (SGKC), The German Association of Technical Assistants in Medicine (dvta), Mannheim, Germany, October 1st - 4th, 2006
- First Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC), Salzburg, October 4 – 7, 2006