Home Validation of a point-of-care (POC) lactate testing device for fetal scalp blood sampling during labor: clinical considerations, practicalities and realities
Article
Licensed
Unlicensed Requires Authentication

Validation of a point-of-care (POC) lactate testing device for fetal scalp blood sampling during labor: clinical considerations, practicalities and realities

  • Philipp Reif EMAIL logo , Ioanna Lakovschek , Carmen Tappauf , Josef Haas , Uwe Lang and Wolfgang Schöll
Published/Copyright: January 9, 2014
Become an author with De Gruyter Brill
Submit Manuscript Author Information
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 52 Issue 6

Abstract

Background: Although fetal blood sampling for pH is well established the use of lactate has not been widely adopted. This study validated the performance and utility of a handheld point-of-care (POC) lactate device in comparison with the lactate and pH values obtained by the ABL 800 blood gas analyzer.

Methods: The clinical performance and influences on accuracy and decision-making criteria were assessed with freshly taken fetal blood scalp samples (n=57) and umbilical cord samples (n=310). Bland-Altman plot was used for data plotting and analyzing the agreement between the two measurement devices and correlation coefficients (R2) were determined using Passing‐Bablok regression analysis.

Results: Sample processing errors were much lower in the testing device (22.8% vs. 0.5%). Following a preclinical assessment and calibration offset alignment (0.5 mmol/L) the test POC device showed good correlation with the reference method for lactate FBS (R2=0.977, p<0.0001, 95% CI 0.9 59–0.988), arterial cord blood (R2=0.976, p<0.0001, 95% CI 0.967–0.983) and venous cord blood (R2=0.977, p<0.0001, 95% CI 0.968–0.984).

Conclusions: A POC device which allows for a calibration adjustment to be made following preclinical testing can provide results that will correlate closely to an incumbent lactate method such as a blood gas analyzer. The use of a POC lactate device can address the impracticality and reality of pH sample collection and testing failures experienced in day to day clinical practice. For the StatStrip Lactate meter we suggest using a lactate cut-off of 5.1 mmol/L for predicting fetal acidosis (pH<7.20).

Keywords: blood lactate; cord blood; fetal scalp pH; point-of-care testing (POC)
Corresponding author: Philipp Reif, MD, Department of Obstetrics and Gynecology, Medical University of Graz, Austria Auenbruggerplatz 14, 8036 Graz, Austria, Phone: +43 316 38580053, Mobile: +43 699 11883089, Fax: +43 316 681835, E-mail:

Acknowledgment

We thank Nova biomedical (Waltham, MA, USA) for providing the StatStrip Lactate meter and strips.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

References

1. Strehlow MC. Early identification of shock in critically ill patients. Emerg Med Clin North Am 2010;28:57–66, vii.10.1016/j.emc.2009.09.006Search in Google Scholar PubMed

2. Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, et al. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock 2009;32:35–9.10.1097/SHK.0b013e3181971d47Search in Google Scholar PubMed

3. Jansen TC, van Bommel J, Woodward R, Mulder PG, Bakker J. Association between blood lactate levels, sequential organ failure assessment subscores, and 28-day mortality during early and late intensive care unit stay: a retrospective observational study. Crit Care Med 2009;37:2369–74.10.1097/CCM.0b013e3181a0f919Search in Google Scholar PubMed

4. Jansen TC, van Bommel J, Mulder PG, Lima AP, van der Hoven B, Rommes JH, et al. Prognostic value of blood lactate levels: does the clinical diagnosis at admission matter? J Trauma 2009;66:377–85.10.1097/TA.0b013e3181648e2fSearch in Google Scholar PubMed

5. Saling E. A new method for examination of the child during labor. Introduction, technic and principles. Arch Gynakol 1962;197:108–22.10.1007/BF02590014Search in Google Scholar PubMed

6. Ramanah R, Martin A, Riethmuller D, Maillet R, Schaal J-P. Value of fetal scalp lactate sampling during labour: a comparative study with scalp pH. Gynecol Obstet Fertil 2005;33:107–12.10.1016/j.gyobfe.2005.01.004Search in Google Scholar PubMed

7. Wiberg-Itzel E, Lipponer C, Norman M, Herbst A, Prebensen D, Hansson A, et al. Determination of pH or lactate in fetal scalp blood in management of intrapartum fetal distress: randomised controlled multicentre trial. Br Med J 2008;336:1284–7.10.1136/bmj.39553.406991.25Search in Google Scholar PubMed PubMed Central

8. East CE, Leader LR, Sheehan P, Henshall NE, Colditz PB. Intrapartum fetal scalp lactate sampling for fetal assessment in the presence of a non-reassuring fetal heart rate trace. Cochrane Database Syst Rev 2010;(3):CD006174. DOI: 10.1002/14651858.CD006174.pub2.10.1002/14651858.CD006174.pub2Search in Google Scholar PubMed

9. Westgren M, Kruger K, Ek S, Grunevald C, Kublickas M, Naka K, et al. Lactate compared with pH analysis at fetal scalp blood sampling: a prospective randomised study. Br J Obstet Gynaecol 1998;105:29–33.10.1111/j.1471-0528.1998.tb09346.xSearch in Google Scholar PubMed

10. Westgren M, Kublickas M, Kruger K. Role of lactate measurements during labor. Obstet Gynecol Surv 1999;54:43–8.10.1097/00006254-199901000-00023Search in Google Scholar PubMed

11. Borruto F, Comparetto C, Treisser A. Prevention of cerebral palsy during labour: role of foetal lactate. Arch Gynecol Obstet 2008;278:17–22.10.1007/s00404-007-0531-1Search in Google Scholar PubMed

12. Holzmann M, Cnattingius S, Nordstrom L. Outcome of severe intrapartum acidemia diagnosed with fetal scalp blood sampling. J Perinat Med 2011;39:545–8.10.1515/jpm.2011.062Search in Google Scholar PubMed

13. Heinis AM, Spaanderman ME, Gunnewiek JM, Lotgering FK. Scalp blood lactate for intra-partum assessment of fetal metabolic acidosis. Acta Obstet Gynecol Scand 2011;90: 1107–14.10.1111/j.1600-0412.2011.01237.xSearch in Google Scholar PubMed

14. Fischer N, Strobl S, Otto R, Schoell W. Wertigkeit von Laktat in der fetalen Mikroblutanalyse. Geburtsh Frauenheilk 2010;70:P09. DOI:10.1055/s-0030-1254925.10.1055/s-0030-1254925Search in Google Scholar

15. Borruto F, Comparetto C, Wegher E, Treisser A. Screening of foetal distress by assessment of umbilical cord lactate. Clin Exp Obstet Gynecol 2006;33:219–22.Search in Google Scholar

16. Carbonne B, Nguyen A. Fetal scalp blood sampling for pH and lactate measurement during labour. J Gynecol Obstet Biol Reprod (Paris) 2008;37(Suppl 1):S65–71.Search in Google Scholar

17. White CR, Mok T, Doherty DA, Henderson JJ, Newnham JP, Pennell CE. The effect of time, temperature and storage device on umbilical cord blood gas and lactate measurement: a randomized controlled trial. J Matern Fetal Neonatal Med 2012;25:587–94.10.3109/14767058.2011.596959Search in Google Scholar PubMed

18. Dungan K, Chapman J, Braithwaite SS, Buse J. Glucose measurement: confounding issues in setting targets for inpatient management. Diabetes Care 2007;30:403–9.10.2337/dc06-1679Search in Google Scholar PubMed

19. CLSI. Method comparison and bias estimation using patient samples; approved guideline, 2nd ed. (interim revision). CLSI document EP09-A2 IR. Wayne, PA: Clinical and Laboratory Standards Institute, 2010.Search in Google Scholar

20. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307–10.Search in Google Scholar

21. Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709–20.Search in Google Scholar

22. Ramanah R, Martin A, Clement M-C, Maillet R, Riethmuller D. Fetal scalp lactate microsampling for non-reassuring fetal status during labor: a prospective observational study. Fetal Diagn Ther 2010;27:14–9.10.1159/000262281Search in Google Scholar PubMed

23. Paris A, Maurice-Tison S, Coatleven F, Vandenbossche F, Dallay D, Horovitz J. Interest of lactate micro-dosage in scalp and umbilical cord in cases of abnormal fetal heart rate during labor. Prospective study on 162 patients. J Gynecol Obstet Biol Reprod 2012;41:324–32.10.1016/j.jgyn.2011.11.002Search in Google Scholar PubMed

24. Orsonneau J-L, Fraissinet F, Sébille-Rivain V, Dudouet D, Bigot-Corbel E. Suitability of POC lactate methods for fetal and perinatal lactate testing: considerations for accuracy, specificity and decision making criteria. Clin Chem Lab Med 2013;51: 397–404.10.1515/cclm-2012-0201Search in Google Scholar PubMed

25. Ridenour RV, Gada RP, Brost BC, Karon BS. Comparison and validation of point of care lactate meters as a replacement for fetal pH measurement. Clin Biochem 2008;41:1461–5.10.1016/j.clinbiochem.2008.08.088Search in Google Scholar PubMed

26. Heinis AM, Dinnissen J, Spaanderman ME, Lotgering FK, Gunnewiek JM. Comparison of two point-of-care testing (POCT) devices for fetal lactate during labor. Clin Chem Lab Med 2012;50:89–93.10.1515/cclm.2011.734Search in Google Scholar

27. Luttkus AK, Fotopoulou C, Sehouli J, Stupin J, Dudenhausen JW. Technical performance of lactate biosensors and a test-strip device during labour. Z Geburtshilfe Neonatol 2010;214:62–7.10.1055/s-0030-1249641Search in Google Scholar

28. Duerbeck NB, Chaffin DG, Seeds JW. A practical approach to umbilical artery pH and blood gas determinations. Obstet Gynecol 1992;79:959–62.Search in Google Scholar

29. Armstrong L, Stenson B. Effect of delayed sampling on umbilical cord arterial and venous lactate and blood gases in clamped and unclamped vessels. Arch Dis Child Fetal Neonatal Ed 2006;91:F342–5.10.1136/adc.2005.086744Search in Google Scholar

30. Karon BS, Scott R, Burritt MF, Santrach PJ. Comparison of lactate values between point-of-care and central laboratory analyzers. Am J Clin Pathol 2007;128:168–71.10.1309/HBQEFDPH34MKK5GPSearch in Google Scholar

31. Nordström L, Chua S, Roy A, Arulkumaran S. Quality assessment of two lactate test strip methods suitable for obstetric use. J Perinat Med 1998;26:83–8.10.1515/jpme.1998.26.2.83Search in Google Scholar

32. Kruger K, Hallberg B, Blennow M, Kublickas M, Westgren M. Predictive value of fetal scalp blood lactate concentration and pH as markers of neurologic disability. Am J Obstet Gynecol 1999;181:1072–8.10.1016/S0002-9378(99)70083-9Search in Google Scholar

Received: 2013-9-4
Accepted: 2013-12-2
Published Online: 2014-1-9
Published in Print: 2014-6-1

©2014 by Walter de Gruyter Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Quo vadis, biomarkers?
  4. Translational researchers beware! Unreliable commercial immunoassays (ELISAs) can jeopardize your research
  5. Reviews
  6. Tracing a roadmap for vitamin B12 testing using the health technology assessment approach
  7. Meta-analysis: diagnostic accuracy of anti-cyclic citrullinated peptide 2 antibody and anti-cyclic citrullinated peptide 3 antibody in rheumatoid arthritis
  8. Perspectives
  9. Present and future of cancer biomarkers
  10. Opinion Paper
  11. A repository for “rare” tumor markers?
  12. Genetics and Molecular Diagnostics
  13. Characterization of a complex CYP2D6 genotype that caused an AmpliChip CYP450 Test® no-call in the clinical setting
  14. General Clinical Chemistry and Laboratory Medicine
  15. Tighter precision target required for lactate testing in patients with lactic acidosis
  16. The revised Lund-Malmö GFR estimating equation outperforms MDRD and CKD-EPI across GFR, age and BMI intervals in a large Swedish population
  17. Validation of a point-of-care (POC) lactate testing device for fetal scalp blood sampling during labor: clinical considerations, practicalities and realities
  18. Dabigatran, rivaroxaban, apixaban, argatroban and fondaparinux and their effects on coagulation POC and platelet function tests
  19. Evaluation of clinical cases in External Quality Assessment Scheme (EQAS) for the urinary sediment
  20. N Latex FLC serum free light-chain assays in patients with renal impairment
  21. A new high-sensitive nephelometric method for assaying serum C-reactive protein based on phosphocholine interaction
  22. A sensitive chemiluminescence imaging immunoassay for simultaneous detection of serum oxidized lipoprotein(a) and low density lipoprotein
  23. Quantification of teicoplanin in plasma by LC-MS with online sample clean-up and comparison with QMS® assay
  24. Cancer Diagnostics
  25. An epidemiology-based model to estimate the rate of inappropriateness of tumor marker requests
  26. Evaluation of INK4A promoter methylation using pyrosequencing and circulating cell-free DNA from patients with hepatocellular carcinoma
  27. Cardiovascular Diseases
  28. The in vitro stability of novel cardiovascular and sepsis biomarkers at ambient temperature
  29. Analytical evaluation of the automated galectin-3 assay on the Abbott ARCHITECT immunoassay instruments
  30. Infectious Diseases
  31. Serum miR-122 levels are related to coagulation disorders in sepsis patients
  32. Letter to the Editors
  33. Effect of storage conditions and freeze/thaw cycles on serum and plasma levels of anti-acetylcholine receptor (AChR) antibody
  34. Enzymatic isotope dilution mass spectrometry (IDMS) traceable serum creatinine is preferable over Jaffe in neonates and young infants
  35. Vitamin D, atopy, immunity
  36. 25-Hydroxy vitamin D levels in chronic urticaria and its correlation with disease severity from a tertiary care centre in South India
  37. High prevalence of anti-thyroid antibodies associated with a low vitamin D status in a pediatric cohort
  38. Serum melatonin levels in psoriasis and associated depressive symptoms
  39. Congress Abstracts
  40. ISMD2014 Tenth International Symposium on Molecular Diagnostics
https://doi.org/10.1515/cclm-2013-0732
Keywords for this article
blood lactate; cord blood; fetal scalp pH; point-of-care testing (POC)

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Quo vadis, biomarkers?
  4. Translational researchers beware! Unreliable commercial immunoassays (ELISAs) can jeopardize your research
  5. Reviews
  6. Tracing a roadmap for vitamin B12 testing using the health technology assessment approach
  7. Meta-analysis: diagnostic accuracy of anti-cyclic citrullinated peptide 2 antibody and anti-cyclic citrullinated peptide 3 antibody in rheumatoid arthritis
  8. Perspectives
  9. Present and future of cancer biomarkers
  10. Opinion Paper
  11. A repository for “rare” tumor markers?
  12. Genetics and Molecular Diagnostics
  13. Characterization of a complex CYP2D6 genotype that caused an AmpliChip CYP450 Test® no-call in the clinical setting
  14. General Clinical Chemistry and Laboratory Medicine
  15. Tighter precision target required for lactate testing in patients with lactic acidosis
  16. The revised Lund-Malmö GFR estimating equation outperforms MDRD and CKD-EPI across GFR, age and BMI intervals in a large Swedish population
  17. Validation of a point-of-care (POC) lactate testing device for fetal scalp blood sampling during labor: clinical considerations, practicalities and realities
  18. Dabigatran, rivaroxaban, apixaban, argatroban and fondaparinux and their effects on coagulation POC and platelet function tests
  19. Evaluation of clinical cases in External Quality Assessment Scheme (EQAS) for the urinary sediment
  20. N Latex FLC serum free light-chain assays in patients with renal impairment
  21. A new high-sensitive nephelometric method for assaying serum C-reactive protein based on phosphocholine interaction
  22. A sensitive chemiluminescence imaging immunoassay for simultaneous detection of serum oxidized lipoprotein(a) and low density lipoprotein
  23. Quantification of teicoplanin in plasma by LC-MS with online sample clean-up and comparison with QMS® assay
  24. Cancer Diagnostics
  25. An epidemiology-based model to estimate the rate of inappropriateness of tumor marker requests
  26. Evaluation of INK4A promoter methylation using pyrosequencing and circulating cell-free DNA from patients with hepatocellular carcinoma
  27. Cardiovascular Diseases
  28. The in vitro stability of novel cardiovascular and sepsis biomarkers at ambient temperature
  29. Analytical evaluation of the automated galectin-3 assay on the Abbott ARCHITECT immunoassay instruments
  30. Infectious Diseases
  31. Serum miR-122 levels are related to coagulation disorders in sepsis patients
  32. Letter to the Editors
  33. Effect of storage conditions and freeze/thaw cycles on serum and plasma levels of anti-acetylcholine receptor (AChR) antibody
  34. Enzymatic isotope dilution mass spectrometry (IDMS) traceable serum creatinine is preferable over Jaffe in neonates and young infants
  35. Vitamin D, atopy, immunity
  36. 25-Hydroxy vitamin D levels in chronic urticaria and its correlation with disease severity from a tertiary care centre in South India
  37. High prevalence of anti-thyroid antibodies associated with a low vitamin D status in a pediatric cohort
  38. Serum melatonin levels in psoriasis and associated depressive symptoms
  39. Congress Abstracts
  40. ISMD2014 Tenth International Symposium on Molecular Diagnostics
Sign up now to receive a 20% welcome discount
Institutional Access
How does access work?
Have an idea on how to improve our website?
Please write us.
© 2025 De Gruyter Brill
Downloaded on 5.9.2025 from https://www.degruyterbrill.com/document/doi/10.1515/cclm-2013-0732/html
Scroll to top button