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The utility of six over-the-counter (home) pregnancy tests

  • Laurence A. Cole
Veröffentlicht/Copyright: 14. Juli 2011
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 49 Heft 8

Abstract

Background: The home pregnancy market is rapidly evolving. It has moved from detection of pregnancy on the day of missed menstrual bleeding, to detection claims 4 days prior. It is moving from all manual tests to digital tests, with a monitor reading the bands and informing women they are pregnant. A thorough study is needed to investigate the validity of claims and evolving usefulness of devices.

Methods: Studies were proposed to examine the sensitivity and specificity of home tests and their abilities to detect pregnancy. Methods examined the abilities of tests to detect human chorionic gonadotropin (hCG), hyperglycosylated hCG, free β-subunit, a mixture of these antigens in 40 individual early pregnancy urines.

Results: Using a mixture of hCG, hyperglycosylated hCG and free β-subunit typical for early pregnancy, the sensitivity of the First Response manual and digital tests was 5.5 mIU/mL, while the sensitivities of the EPT and ClearBlue brand manual and digital tests was 22 mIU/mL. On further evaluation, the First Response manual and digital tests both detected 97% of 120 pregnancies on the day of missed menstrual bleeding. The EPT manual and digital devices detected 54% and 67% of pregnancies, respectively, and the ClearBlue manual and digital devices detected 64% and 54% of pregnancies, respectively.

Conclusions: First Response manual and digital claim >99% detection on the day of missed menses. The results here suggest similar sensitivity for these two tests. The EPT and ClearBlue manual and digital test make similar >99% claims, the data presented here disputes their elevated claim.

Corresponding author: Laurence A. Cole, Department of Obstetrics and Gynecology, USA hCG Reference Service, MSC10-5580, University of New Mexico, Albuquerque, NM 87131, USA Phone: +1-505-272-6137
Received: 2010-10-28
Accepted: 2011-03-13
Published Online: 2011-07-14
Published in Print: 2011-08-01

©2011 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/CCLM.2011.211

Artikel in diesem Heft

  1. Editorial
  2. Pneumatic tube delivery systems for patient samples: evidence of quality and quality of evidence
  3. Reviews
  4. Translating pharmacogenetics into clinical practice: interleukin (IL)28B and inosine triphosphatase (ITPA) polymophisms in hepatitis C virus (HCV) infection
  5. New biomarkers for acute renal injury
  6. Minireview
  7. Post-mortem biochemistry of vitreous humor and glucose metabolism: an update
  8. Opinion Paper
  9. International Osteoporosis Foundation and International Federation of Clinical Chemistry and Laboratory Medicine Position on bone marker standards in osteoporosis
  10. Guidelines and Recommendations
  11. IFCC international conventional reference procedure for the measurement of free thyroxine in serum
  12. Genetics and Molecular Diagnostics
  13. Improving clinical laboratory efficiency: a time-motion evaluation of the Abbott m2000 RealTime and Roche COBAS AmpliPrep/COBAS TaqMan PCR systems for the simultaneous quantitation of HIV-1 RNA and HCV RNA
  14. Enhanced frequency of CFTR gene variants in couples who are candidates for assisted reproductive technology treatment
  15. Customer satisfaction survey to improve the European cystic fibrosis external quality assessment scheme
  16. General Clinical Chemistry and Laboratory Medicine
  17. Effect of sample collection, temperature and time of storage on β-galactosidase and total hexosaminidase activities in dried blood collected on filter paper
  18. Agreement between paired blood gas values in samples transported either by a pneumatic system or by human courier
  19. Golgi protein 73(GP73), a useful serum marker in liver diseases
  20. The utility of six over-the-counter (home) pregnancy tests
  21. N Latex FLC – new monoclonal high-performance assays for the determination of free light chain kappa and lambda
  22. Alterations of the preoperative coagulation profile in patients with acute appendicitis
  23. Cerebrospinal fluid findings in infants with pertussis or parapertussis1)
  24. Calcium pyrophosphate and monosodium urate crystals in synovial fluid as a cause of pseudoeosinophilia
  25. Cardiovascular Disease
  26. Dual activity of serum lipoprotein-associated phospholipase A2 yielding positive and inverse associations with cardiometabolic risk
  27. The value of N-terminal proB-type natriuretic peptide for early identification of myocardial infarction in patients with high-risk non-ST-elevation acute coronary syndromes
  28. Infectious Diseases
  29. Diagnosis and genotyping of Plasmodium falciparum by a DNA biosensor based on quartz crystal microbalance (QCM)
  30. Evaluation of two automated chemiluminescence immunoassays, the LIAISON Treponema Screen and the ARCHITECT Syphilis TP, and the Treponema pallidum particle agglutination test for laboratory diagnosis of syphilis
  31. Letters to the Editor
  32. The preanalytical influence of two different mechanical transport systems on laboratory analysis
  33. Commutability of the ERM-DA470k Reference Material for two assays measuring serum albumin using immunochemical principles
  34. Performance evaluation of the Vitros®3600 immunodiagnostic system for the determination of free thyroid hormones
  35. Towards laboratory knowledge, not data, in 70% of clinical decision-making. What “knowledge management” can add to clinical practice?
  36. How to obtain DNA from injection drug users?
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