Strips of hope: Accuracy of home pregnancy tests and new developments

Geburtshilfe und Frauenheilkunde

Volumn 74, Issue 7, 2014, Pages 661-669

  Gnoth, C ^a,b   Johnson, S ^c  

^a Green ivf ^*  (Germany)

^b UNIVERSITY OF COLOGNE   (Germany)

^c SPD Development Company Limited   (United Kingdom)

Author keywords

hCG; pregnancy; pregnancy test

Indexed keywords

CHORIONIC GONADOTROPIN; LUTEINIZING HORMONE;

ARTICLE; CROWN RUMP LENGTH; DIAGNOSTIC ACCURACY; DIAGNOSTIC KIT; FALSE NEGATIVE RESULT; FETUS ECHOGRAPHY; FIRST TRIMESTER PREGNANCY; GERMANY; GESTATIONAL AGE; HEALTH CARE PERSONNEL; HOME PREGNANCY TEST; HORMONE URINE LEVEL; HUMAN; MATERNAL SERUM; MENSTRUAL CYCLE; MENSTRUATION; PREGNANCY TEST; RISK ASSESSMENT; URINALYSIS;

EID: 84905392493     PISSN: 00165751     EISSN: 14388804     Source Type: Journal    
DOI: 10.1055/s-0034-1368589     Document Type: Article

References (40)

1. Richtlinie 98/79/EG des Europäischen Parlaments und Rates vom 27. Oktober 1998 über In-vitro-Diagnostika, Anhang III.
2. Öko-Test, Ratgeber Gesundheit und Fitness 8/2008.
3. Birken S., Berger P., Bidart J-M et al. Preparation and characterisation of new WHO standards for human chorionic gonadotropin and metabolites. Clin Chem: 2003; 49 144 154
4. Bristow A., Berger P., Bidart J. et al. Establishment, value assignment, and characterization of new WHO reference reagents for six molecular forms of human chorionic gonadotropin. Clin Chem: 2005; 51 177 182
5. Sturgeon C. M., Berger P., Bidart J. et al. Differences in recognition of the 1st WHO international reference reagents for hCG-related isoforms by diagnostic immunoassays for human chorionic gonadotropin. Clin Chem: 2009; 55 1484 1491
6. Alfthan H., Stenman U-H. Pregnancy serum contains the core fragment of human chroriogonadotropin. J Clin Endocrinol Metab: 1990; 70 783 787
7. Cole L. A., Kardana A., Ying F. C. et al. The biological and clinical significance of nicks in human chorionic gonadotropin and its free beta-subunit. Yale J Biol Med: 1991; 64 627 637
8. McChesney R., Wilcox A. J., O'Connor J. F. et al. Intact HCG, free HCG beta subunit and HCG beta core fragment: longitudinal patterns in urine during early pregnancy. Hum Reprod: 2005; 20 928 935
9. Kovalevskaya G., Birken S., Kakuma T. et al. Early pregnancy human chorionic gonadotropin (hCG) isoforms measured by an immunometric assay for choriocarcinoma-like hCG. J Endocrinol: 1999; 161 99 106
10. Kovalevskaya G., Kakuma T., Schlatterer J. et al. Hyperglycosylated hCG expression in pregnancy: cellular origin and clinical applications. Mol Cell Endocrinol: 2007; 260 237 243
11. Butler S. A., Khanlian S. A., Cole L. A. Detection of early pregnancy forms of human chorionic gonadotropin by home pregnancy test devices. Clin Chem: 2001; 47 2131 2136
12. Whittington J., Fantz C. R., Gronowski A. M. et al. The analytical specificity of human chorionic gonadotropin assays determined using WHO International Reference Reagents. Clin Chim Acta: 2010; 411 81 85
13. Stewart B. K., Nazar-Stewart V., Tiovola B. Biochemical discrimination of pathologic pregnancy from early, normal intrauterine gestation in symptomatic patients. Am J Clin Pathol: 1995; 103 386 390
14. Zegers-Hochschild F., Altierl E., Fabres C. et al. Predictive value of human chorionic gonadotrophin in the outcome of early pregnancy after in-vitro fertilization and spontaneous conception. Hum Rep: 1994; 9 1550 1555
15. Barnhart K. T., Sammel M. D., Rinaudo P. F. et al. Symptomatic patients with an early viable intrauterine pregnancy: hCG curves redefined. Obstet Gynecol: 2004; 104 50 55
16. Norman R. J., Menabawey M., Lowings C. et al. Relationship between blood and urinary concentrations of intact human chorionic gonadotropin and its free subunits in early pregnancy. Obstet Gynecol: 1987; 69 590 593
17. Johnson S. R., Miro F., Barrett S. et al. Levels of urinary human chorionic gonadotrophin (hCG) following conception and variability of menstrual cycle length in a cohort of women attempting to conceive. Curr Med Res Opin: 2009; 25 741 748
18. Larsen J., Buchanan P., Johnson S. et al. Human chorionic gonadotropin as a measure of pregnancy duration. Int J Gynaecol Obstet: 2013; 123 189 195
19. Eskild A., Fedorcsak P., Morkrid L. et al. Maternal body mass index and serum concentrations of human chorionic gonadotropin in very early pregnancy. Fertil Steril: 2012; 98 905 910
20. Lenton E. A., Landgren B. M., Sexton L. et al. Normal variation in the length of the follicular phase of the menstrual cycle: effect of chronological age. Br J Obstet Gynaecol: 1984; 91 681 684
21. Creinin M. D., Keverline S., Meyn L. A. How regular is regular? An analysis of menstrual cycle regularity. Contraception: 2004; 70 289 292
22. Geirsson R. T., Busby-Earle R. M. Certain dates may not provide a reliable estimate of gestational age. Br J Obstet Gynaecol: 1991; 98 108 109
23. Waller D. K., Spears W. D., Gu Y. et al. Assessing number-specific error in the recall of onset of last menstrual period. Paediatr Perinat Epidemiol: 2000; 14 262 267
24. Haarburger D., Pillay T. S. Historical perspectives in diagnostic clinical pathology: development of the pregnancy test. J Clin Pathol: 2011; 64 546 548
25. Wide L., Gemzell C. A. An immunological pregnancy test. Acta Endocrinol (Copenh): 1960; 35 261 267
26. Scolaro K. L., Braxton-Lloyd K., Helms K. L. Devices for home evaluation of women's health concerns. Am J Health Syst Pharm: 2008; 65 299 314
27. Johnson S. R., Godbert S., Perry P. et al. Accuracy of a home-based device for giving an early estimate of pregnancy duration compared with reference methods. Fertil Steril: 2013; 100 1635 1641
28. Johnson S., Shaw R., Parkinson P. Home pregnancy test compared to standard-of-care ultrasound dating in the assessment of pregnancy duration. Curr Med Res Opin: 2011; 27 393 401
29. Mustafa G., David R. J. Comparative accuracy of clinical estimate versus menstrual gestational age in computerized birth certificates. Public Health Rep: 2001; 116 15 21
30. Johnson S., Godbert S. Comparison of home pregnancy test with weeks estimator and ultrasound crown rump measurement to predict delivery date. Fertil Steril: 2013; 100 3 Suppl. S330
31. Cole L. A., Khanlian S., Sutton J. et al. Accuracy of home pregnancy tests at the time of missed menses. Am J Obstet Gynecol: 2004; 190 100 103
32. Bastian L. A., Nanda K., Hasselblad V. et al. Diagnostic efficiency of home pregnancy test kits: a meta-analysis. Arch Fam Med: 1998; 7 465 469
33. Daviaud J., Fournet D., Ballonque C. et al. Reliability and feasibility of home-use tests: laboratory validation and diagnostic evaluation by 638 volunteers. Clin Chem: 1993; 39 53 59
34. Wallace L. S., Zite N. B., Homewood V. J. Making sense of home pregnancy test instructions. J Womens Health: 2009; 18 363 368
35. Tomlinson C., Marshall J., Ellis J. E. Comparison of accuracy and certainty of results of six home pregnancy tests available over-the-counter. Curr Med Res Opin: 2008; 24 1645 1649
36. Pike J., Godbert S., Johnson S. Comparison of volunteers' experience of using, and accuracy of reading, different types of home pregnancy test formats. Expert Opin Med Diagn: 2013; 7 435 441
37. Geirsson R. T. Ultrasound instead of last menstrual period as the basis of gestational age assignment. Ultrasound Obstet Gynecol: 1991; 1 212 219
38. Wilcox A. J., Baird D. D., Weinberg C. R. Time of implantation of the conceptus and loss of pregnancy. N Engl J Med: 1999; 340 1796 1799
39. Gronowski A. M., Cervinski M., Stenman U. et al. False-negative results in point-of-care qualitative human chorionic gonadotropin (hCG) devices due to excess hCG-beta core fragment. Clin Chem: 2009; 55 1389 1394
40. Snyder J. A., Haymond S., Parvin C. A. et al. Diagnostic considerations in the measurement of human chorionic gonadotropin in aging women. Clin Chem: 2005; 51 1830 1835