Korean Journal of Clinical Laboratory Science (대한임상검사과학회지)

Korean Society for Clinical Laboratory Science (대한임상검사과학회)
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Development History of Pregnancy Test Technology

임신진단검사기술의 발전사

  • Kwon, Young-Il (Department of Biomedical Laboratory Science, Shinhan University)
  • 권영일 (신한대학교 임상병리학과)
  • Received : 2018.10.12
  • Accepted : 2018.10.29
  • Published : 2018.12.31
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Abstract

The history of the pregnancy test started in ancient Egypt with a germination test using wheat and barley. Since then, unscientific methods have been used from the days of Hippocrates and Galen to the Middle Ages when uroscopy was used, even until the early 1800s. On the other hand, since the mid-1800s, scientific methods and evidence have begun to emerge, which led to scientific research on the physiological characteristics of pregnancy. The first attempt to utilize these scientific findings was initiated with the bioassay by Aschheim and Zondek using rats and mice in 1927, and then developed into experiments using rabbits and frogs. The immunoassay method, which started in the 1960s, contributed greatly to the generalization of the pregnancy tests while improving the problems of the bioassay. In 1976, a pregnancy test kit was introduced that can be used at home, contributing to the popularization of pregnancy tests. Since the 1980s, technological advances in diagnostic tests have also been applied to pregnancy tests to further improve the reliability of the diagnosis of pregnancy. In the 2000s, the accuracy and ease of use of the pregnancy test kits for home use have improved drastically. This study examined the history and scientific development of the pregnancy test.

임신진단검사는 고대 이집트에서 밀과 보리를 이용한 발아시험으로 시작하였다. 이후 Hippocrates와 Galen을 거쳐 uroscopy를 활용하던 중세를 넘어 1800년대 초반까지도 비과학적 방법들이 사용되었다. 그러나 1800년대 중반 이후 과학적 실험방법과 근거들이 나타나기 시작하면서 임신의 생리학적 특성에 대한 과학적 연구들이 시작되었다. 이와 같은 과학적 연구결과를 활용하려는 최초 시도는1927년 Aschheim와 Zondek의 rat와 mouse를 이용한 bioassay로 시작되었고, 이후 토끼와 개구리를 이용하는 실험으로 발전하였다. 1960년대부터 시작된 면역검사방법은 bioassay의 문제점을 개선하면서 임신진단검사를 일반화하는데 크게 기여하였다. 1976년에는 가정에서 사용할 수 있는 임신진단키트가 출시되어 임신진단을 대중화하는데 기여하였다. 1980년대 이후 진단검사의 기술적 진보는 임신진단검사에도 활용되어 임신진단의 검사신뢰도는 더욱 향상되었으며, 2000년대에는 가정용 임신진단키트의 정확도와 사용편리성이 혁신적으로 향상되었다. 본 조사에서는 임신진단검사의 역사와 과학적 발전과정을 고찰하였다.

Keywords

References

  1. Bayon HP. Ancient pregnancy tests in the light of contemporary knowledge. Proc R Soc Med. 1939;32:1527-1538.
  2. Evans HM, Simpson ME. Aschheim-Zondek test for pregnancy-Its present status. Cal West Med. 1930;32:145-148.
  3. Damewood MD, Rock JA. In memoriam: Georgeanna Seegar Jones, M.D.: her legacy lives on. Fertil Steril. 2005;84:541-542. https://doi.org/10.1016/j.fertnstert.2005.04.019
  4. Elkan ER. The Xenopus pregnancy test. Br Med J. 1938;2:1253-1256, 1274-2. https://doi.org/10.1136/bmj.2.4067.1253
  5. Brody H. The use of the male leopard frog (Rana pipiens) as a pregnancy test animal. Am J Obstet Gynecol. 1949;57:581-585. https://doi.org/10.1016/0002-9378(49)90246-X
  6. Giltz ML, Miller DF. Ways of improving the male frog test for pregnancy. Ohio Journal of Science. 1950;50:205-209.
  7. Marsters RW, Black ME, Randall JD. An evaluation of the Rana pipiens male frog pregnancy test. Am J Obstet Gynecol. 1950;60:752-762. https://doi.org/10.1016/S0002-9378(16)39100-1
  8. Hon EH, Morris JM. Evaluation of male Bufo americanus and Rana pipiens for pregnancy testing. Am J Obstet Gynecol. 1956;71:331-341. https://doi.org/10.1016/S0002-9378(16)37596-2
  9. Office of NIH History. A thin blue line. A timeline of pregnancy Testing. Bethesda: National Institute of Health; Office of NIH History. 2018 [cited 2018 October 1]. Available from: https://history.nih.gov/exhibits/thinblueline/timeline.html.
  10. Modlin IM, Kidd M. Ernest Starling and the discovery of secretin. J Clin Gastroenterol. 2001;32:187-192. https://doi.org/10.1097/00004836-200103000-00001
  11. Simmer HH. The first experiments to demonstrate an endocrine function of the corpus luteum. On the occasion of the 100th birthday of Ludwig Fraenkel (1870-1951). Sudhoffs Arch. 1971;55:392-417.
  12. Schneck P. Selmar Aschheim (1878-1965) and Bernhard Zondek (1891-1966). On the fate of 2 Jewish physicians and researchers at the Berlin Charite Hospital. Z Arztl Fortbild Qualitatssich. 1997;91:187-194.
  13. Ferreira HP. The relative merits of the various biological tests for pregnancy. Postgrad Med J. 1954;30:355-359. https://doi.org/10.1136/pgmj.30.345.355
  14. Ruediger EH. The Aschheim-zondek test for pregnancy. Cal West Med. 1936;44:157-159.
  15. Hannan JH. The detection of the presence of the hormone of the anterior pituitary body in the urine as an aid to the diagnosis of pregnancy. Proc R Soc Med. 1930;3:634-639.
  16. Olszynko-Gryn J. The demand for pregnancy testing: the Aschheim-Zondek reaction, diagnostic versatility, and laboratory services in 1930s Ruediger. Stud Hist Philos Biol Biomed Sci. 2014;47:233-247. https://doi.org/10.1016/j.shpsc.2013.12.002.
  17. Friedman MH, Lapham ME. A simple, rapid procedure for the laboratory diagnosis of early pregnancies. Amer J Obstet Gynec. 1931;21:405-410. https://doi.org/10.1016/S0002-9378(16)42174-5
  18. Cabrera HA. A comprehensive evaluation of pregnancy tests. Am J Obstet Gynecol. 1969;103:32-38. https://doi.org/10.1016/S0002-9378(16)34336-8
  19. Kracke RR. Textbook of clinical pathology. 1st ed. London:Bailliere & Co.; 1938. p513.
  20. Miller DF, Wiltberger, PB. Some peculiarities of the male frog test for early pregnancy. Ohio J Sci. 1948;48:89-94.
  21. Galli-Mainini C. Pregnancy test using the male toad. J Clin Endocrinol. 1947;7:653-658. https://doi.org/10.1210/jcem-7-9-653
  22. Haines M. Pregnancy test using the male toad. Nature. 1948;11:162:416.
  23. Aznar-Ferreres J. Pregnancy test using male anura. Nature. 1949;163:881-882.
  24. Carrain G. Rapid response to Galli-Mainini test in early diagnosis pregnancy. Riv Ostet Ginecol Prat. 1954;36:421-423.
  25. Floch H, Fauran P. Early diagnosis of pregnancy by the Galli-Mainini test. Rev Pathol Gen Physiol Clin. 1955;55:1260-1270.
  26. Vaitukaitis JL, Braunstein GD, Ross GT. A radioimmunoassay which specifically measures human chorionic gonadotropin in the presence of human luteinizing hormone. Am J Obstet Gynecol. 1972;113:751-758. https://doi.org/10.1016/0002-9378(72)90553-4
  27. Vredenburg VT, Felt SA, Morgan EC, McNally SV, Wilson S, Green SL. Prevalence of Batrachochytrium dendrobatidis in Xenopus collected in Africa (1871-2000) and in California (2001-2010). PLoS One. 2013;15;8:e63791. https://doi.org/10.1371/ journal.pone.0063791.
  28. Wide L, Gemzell CA. An immunological pregnancy test. Acta Endocrinol. 1960;35:261-267.
  29. Butt WR, Crooke AC, Cunningham FJ. Immunological study of human gonadotrophins. Proc R Soc Med. 1961;54:647-648.
  30. Loraine JA. Assay of human chorionic gonadotrophin in relation to clinical practice. J Reprod Fert. 1966:12:23-31. https://doi.org/10.1530/jrf.0.0120023
  31. Fulthorpe AJ, Parke JA, Tovey JE, Monckton JC. Pregnancy diagnosis by a one-stage passive haemagglutination inhibition method. Br Med J. 1963;20:1049-1054.
  32. Petchclai B, Pongdherapol U. A new microhemagglutination inhibition pregnancy test. Am J Clin Pathol. 1970;54:810-812. https://doi.org/10.1093/ajcp/54.6.810
  33. Robbins JL, Hill GA, Carle BN, Carlquist JH, Marcus S. Latex agglutination reactions between human chorionic gonadotropin and rabbit antibody. Proc Soc Exp Biol Med. 1962;109: 321-325. https://doi.org/10.3181/00379727-109-27190
  34. Islami ZS, Fisher LM, Kupfer HG. Rapid slide test for pregnancy. Am J Obstet Gynecol. 1964;89:586-589. https://doi.org/10.1016/0002-9378(64)90150-4
  35. Bell JL. Comparative study of immunological tests for pregnancy diagnosis. J Clin Pathol. 1969;22:79-83. https://doi.org/10.1136/jcp.22.1.79
  36. Hancsok M, Huber G, Pahoki I, Czeizel E. Experience with Pregnosticon-planotest, a 2-minute immunologic pregnancy test. Zentralbl Gynakol. 1969;91:1113-1116.
  37. Dietrich M, French JA. Evaluation of four slide test kits for the detection of human chorionic gonadotropin in urine. Can Med Assoc J. 1974;111:235-237.
  38. Porres JM, D'Ambra C, Lord D, Garrity F. Comparison of eight kits for the diagnosis of pregnancy. Am J Clin Pathol. 1975;64: 452-463. https://doi.org/10.1093/ajcp/64.4.452
  39. Midgley AR Jr. Radioimmunoassay: a method for human chorionic gonadotropin and human luteinizing hormone. Endocrinology. 1966;79:10-18. https://doi.org/10.1210/endo-79-1-10
  40. Boyko WL, Barrett B. Detection and quantitation of the beta-subunit of human chorionic gonadotropin in serum by radioimmunoassay. Fertil Steril. 1980;33:141-150. https://doi.org/10.1016/S0015-0282(16)44534-6
  41. Saxena B, Hasan SH, Haour F, Schmidt-Gollwitzer M. Radioreceptor assay of human chorionic gonadotropin: detection of early pregnancy. Science 1974;184:793-795. https://doi.org/10.1126/science.184.4138.793
  42. Senterfit LB, Ikeda G. Early pregnancy testing: a comparison of hemagglutination inhibition and radioreceptor assay. Am J Med Technol. 1982;48:145-147.
  43. Shimizu SY, Present WA, Sevier ED, Wang R, Saunders RL. Chorigonadotropin measured by use of monoclonal antibodies in a two-site immunoradiometric assay. Clin Chem. 1982;28:546-547.
  44. van Weemen BK, Schuurs AH. Immunoassay using antigen-enzyme conjugates. FEBS Lett. 1971;15:232-236. https://doi.org/10.1016/0014-5793(71)80319-8
  45. Wada HG, Danisch RJ, Baxter SR, Federici MM, Fraser RC, Brownmiller LJ, et al. Enzyme immunoassay of the glycoprotein tropic hormones-choriogonadotropin, lutropin, thyrotropin--with solid-phase monoclonal antibody for the alpha-subunit and enzyme-coupled monoclonal antibody specific for the beta-subunit. Clin Chem. 1982;28:1862-1866.
  46. Haarburger D, Pillay TS. Historical perspectives in diagnostic clinical pathology: development of the pregnancy test. J Clin Pathol. 2011;64:546-548. https://doi.org/10.1136/jcp.2011.090332
  47. Fletcher JL Jr. Update on pregnancy testing. Prim Care. 1986;13:667-677.
  48. Birnbaum S1, Uden C, Magnusson CG, Nilsson S. Latex-based thin-layer immunoaffinity chromatography for quantitation of protein analytes. Anal Biochem. 1992;206:168-171. https://doi.org/10.1016/S0003-2697(05)80028-4
  49. Gelletlie R, Nielsen JB. Evaluation and comparison of commercially available pregnancy tests based on monoclonal antibodies to human choriogonadotropin. Clin Chem. 1986;32:2166-2170. https://doi.org/10.1093/clinchem/32.12.2166
  50. Doshi ML. Accuracy of consumer performed in-home tests for early pregnancy detection. Am J Public Health. 1986;76: 512-514. https://doi.org/10.2105/AJPH.76.5.512
  51. Scolaro KL, Braxton-Lloyd K, Helms KL. Devices for home evaluation of women's health concerns. Am J Health Syst Pharm. 2008;65:299-314. https://doi.org/10.2146/ajhp060565
  52. Gnoth C, Johnson S. Strips of hope: Accuracy of home pregnancy tests and new developments. Geburtshilfe Frauenheilkd. 2014;74:661-669. https://doi.org/10.1055/s-0034-1368589
  53. Cole LA. Immunoassay of human chorionic gonadotropin, its free subunits, and metabolites. Clin Chem. 1997;43:2233-2243
  54. Butler SA, Khanlian SA, Cole LA. Detection of early pregnancy forms of human chorionic gonadotropin by home pregnancy test devices. Clin Chem. 2001;47:2131-2136.
  55. Cole LA. The hCG assay or pregnancy test. Clin Chem Lab Med. 2012;50:617-630. https://doi.org/10.1515/CCLM.2011.808.
  56. Gronowski AM, Cervinski M, Stenman UH, Woodworth A, Ashby L, Scott MG. 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. https://doi.org/10.1373/clinchem.2008.121210.
  57. Stenman UH, Tiitinen A, Alfthan H, Valmu L. The classification, functions and clinical use of different isoforms of hCG. Hum Reprod Update. 2006;12:769-784. https://doi.org/10.1093/humupd/dml029