임신진단검사기술의 발전사

권영일 대한임상검사과학회 2018 대한임상검사과학회지(KJCLS) Vol.50 No.4

임신진단검사는 고대 이집트에서 밀과 보리를 이용한 발아시험으로 시작하였다. 이후 Hippocrates와 Galen을 거쳐uroscopy를 활용하던 중세를 넘어 1800년대 초반까지도 비과학적 방법들이 사용되었다. 그러나 1800년대 중반 이후 과학적실험방법과 근거들이 나타나기 시작하면서 임신의 생리학적 특성에 대한 과학적 연구들이 시작되었다. 이와 같은 과학적 연구결과를 활용하려는 최초 시도는1927년 Aschheim와 Zondek 의 rat와 mouse를 이용한 bioassay로 시작되었고, 이후 토끼와개구리를 이용하는 실험으로 발전하였다. 1960년대부터 시작된 면역검사방법은 bioassay의 문제점을 개선하면서 임신진단검사를 일반화하는데 크게 기여하였다. 1976년에는 가정에서사용할 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. 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.

응급실에서 현장검사로 시행한 β-hCG 검사의 유용성

김정윤,윤영훈,최성혁,김덕환,유우성,문성우,이성우,홍윤식 대한응급의학회 2011 大韓應急醫學會誌 Vol.22 No.5

Purpose: The rapid and accurate diagnosis of pregnancy is important in the emergency department (ED) before evaluation of radiologic tests and medication decisions. Our primary objective was to assess the agreement between whole blood pregnancy tests done in the emergency department and those done in laboratory [serum human chorionic gonadotropin (β-hCG) and urine β-hCG]. The secondary objective was to compare turnaround times for tests done in the ED and those done in the laboratory. Methods: This prospective study enrolled females of childbearing age needing a pregnancy test who visited an ED. Using whole blood, urine and serum from each patient, testing was done in the ED (whole blood - Hubi Quan pro-point of care test, POCT) and in the laboratory using a urine hCG kit (iIexscreen) and in serum (ADVIA centaur). The data included time of each test, β-hCG result, and urine pregnancy test result. Results: There was a high level of agreement between the POCT using whole blood and the serum β-hCG as indicated by a kappa value of 0.921(95% confidence interval). The POCT performed in the ED was significantly faster in time to report than tests performed in the laboratory, with mean differences of 20.21±2.0 minutes and 36.14±20.86minutes. The sensitivity and specificity of POCT was 98.18% and 93.75%, respectively. Conclusion: In ED, the POCT test can perform pregnancy test as accurately as in the laboratory, and can provide results on which to base care much faster than waiting for the laboratory results. POCT may expedite the ED management of patients who require pregnancy tests. Especially, this POCT uses whole blood instead of the urine, since the latter was inconvenient for the test.

임신 및 분만결과에 따른 경구당부하검사의 분석

김정혜(JH Kim),송혜섭(HS Song),오말례(ML Oh),양석기(SK Yang),민보은(BE Min) 대한산부인과학회 1983 Obstetrics & Gynecology Science Vol.26 No.1

결론 1. 서구인과 비교해 본 저자들의 경구당부하검사는 많은 차이점들 나타내었다. 즉 저자들이 시행한 검사치를 미국인의 것과 비교했을 때 평균치에 있어서 약30~4omg%,2S.D.에서 25~40mg%가 각각 높았다. 그러므로 식생활이 다른 한국인의 임신성 당뇨병 진단에 미국인의 기준치를 적용하는 것은 많은 오류를 범할 수 있다고 생각되므로 좀 더 많은 수의 검사로 한국인의 표준을 정하는 것이 필요하다고 본다. 2. 비정상 임신시 정상 임신에 취하여 비정상 당부하검사를 나타내는 예가 월등히 많았다. 과체중아 분만시에 고혈당치 뿐 아니라 저혈당치의 빈도도 높이 나타났으며 처체중아 분만시에도 고혈당치를 나타내는 빈도가 높았다. 또한 산과력이 나빴던 예에서도 저혈당치를 나타낸 예와 현성당뇨병을 나타낸 예가 많았으며 임신중독증 시에도 고혈당치 뿐 아니라 저혈당치도 높은 빈도를 나타내었다. 3. screening test로써의 single test는 3시간이 의의가 있는 것으로 생각되나 일부의 비정상적인 사람들을 포함하지 못할 수도 있다. 모든 임신부에게 3시간의 single test를 행하는 것이 바람직하나 비정상적인 임신이 기대될 때는 표준당부하검사를 시행하는 것이 좋을 것이다. lt has been wedely recognized that many complications in obstetrics & gynecology are asscoiated with abnormal carbohydrate metabolism. Oral glucose toIerance test is the one of the better tests in diagnsing diabetes mellitus but its value changes depending upon the basic diet, especially amount of carbonhydrate intake. Therefore we thought there may be a difference in glucose tolerance between Western and Korean peoples. Oral glucose tolerance tests were done in 159 control group people, nonpregnant 34, pregnant 59, and postpartum (baby, A.G.A.I.)66, and a group of 389 with abnormali- ties of pregnancy, L.G.A.I.215, S.G.A.I.76, stillbirth unknown cause 22, bad ㅇbstetric history 20, hypertensⅳe disorders in pregnancy 53, and fetal abnormality 3. The results are as follows; 1. There was a marked difference between Korean and American mean oral glucose tolerance test results. This study showed 30~40mg% higher value than American pre- gnancy standard, and 25~40mg% higher in comparing 2 S.D. This study would mean that it would be dangerous if the American standards are used in diagnosis and treat- ment of Gestational Diabetes in Kotea. 2. Abnormal pregnancy showed a more frequent association with abnormai G.T.T. compared to normal pregnancy. Hyperglycemia was associated with L.G.A.I. in 7.9% cases but also hypoglycemia was associated with hyperglycemia. Patients with a bad obstetric history showed 20% hypoglycemia and 15% overt diabetes, but none in the hyperglycemia, not diabetic level. Dypertensⅳe disorders in pregnancy were associated with hyperglycemia as well as hypoglycemia. 3. For singIe Ioading test a 3hr test is probably the best but it would still miss some of the patients with abnormal curves. As a screening test of all pregnant patients the 3hr single loading test could be used but when there is an abnormality of pregnancy it would be adⅵsable to do a full G.T.T.

임신 중기 원인불명 인간 융모성 성선자극호르몬치 상승 임신부의 임신 결과

이윤정(Yun Jung Lee),김세광(Se Kwang Kim),안은희(Eun Hee Ahn),이진우(Jin Woo Lee),권혜경(Hye Kyung Kwon),이창희(Chang Hee Lee),김영한(Young Han Kim),배상욱(Sang Wook Bai),박기현(Ki Hyun Park),양영호(Young Ho Yang),송찬호(Chan Ho Song 대한산부인과학회 2001 Obstetrics & Gynecology Science Vol.44 No.4

N/A Objective : Our purpose was to determine the association between unexplained elevation of maternal serum human chorionic gonadotropin (hCG) in the second trimester and adverse pregnancy outcomes. Material and methods : Between February 1995 and July 1999, we evaluated 1566 pregnant women who have underwent second trimester triple marker screening tests (alpha-fetoprotein, unconjugated estriol, human chorionic gonadotropin) and delivered at Severance Hospital, Yonsei Medical Center. Multiple pregnancies, abnormal fetal karyotypes, fetal anomalies, and abortions were excluded from the study. One hundred twenty-one women with hCG levels greater than 2.0 multiples of the median (MoM) were included in the study group while 1389 women with hCG levels less than 2.0 MoM served as the control group. Pregnancy outcomes were obtained from the delivery and neonatal records in our institution. Adverse pregnancy outcomes between the two groups were compared using chi-square test and Fisher's exact test. Results : Women with unexplained elevation of human chorionic gonadotropin levels were associated with statistically significant increased risks for preeclampsia, preterm delivery, and low birth weight (p<0.05). However, there were no significant differences between the study and control groups with respect to preterm premature rupture of membranes, abnormal fetal heart rate tracing, abruptio placentae, intrauterine fetal death, and neonatal death. Conclusion : An unexplained elevation in human chorionic gonadotropin level in the second trimester may increase the risk for preeclampsia, preterm delivery, and low birth weight but not for other adverse pregnancy outcomes such as preterm premature rupture of membranes, abnormal fetal heart rate tracing, intrauterine fetal death, or neonatal death.

임신 중 비정상 자궁경부 세포검사를 보인 여성의 처치

이인호,이유경,이기헌,김미경 한국모자보건학회 2017 한국모자보건학회지 Vol.21 No.2

Pregnancy provides a unique opportunity for young women to begin participating in the National Cancer Screening Program. The incidence of abnormal Pap smear test results during pregnancy is approximately 5%, and is comparable to that in non-pregnant women. However, normal physiological changes of the cervix during pregnancy can complicate the diagnostic accuracy of the Pap smear test, and prevent appropriate management in women who yield an abnormal test result. To date, no large, prospective clinical trials evaluating the management of women with abnormal Pap smear tests in pregnancy have been performed. Herein, we review and summarize a large series of literature and consensus guidelines on the evaluation of abnormal Pap smear test results and the management of cervical neoplasia in pregnancy.

Pregnancy Outcomes of Women Additionally Diagnosed as Gestational Diabetes by the International Association of the Diabetes and Pregnancy Study Groups Criteria

김민형,곽수헌,김성훈,홍준석,정혜림,최성희,김문영,장학철 대한당뇨병학회 2019 Diabetes and Metabolism Journal Vol.43 No.6

Background: We investigated the pregnancy outcomes in women who were diagnosed with gestational diabetes mellitus (GDM) by the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria but not by the Carpenter-Coustan (CC) criteria. Methods: A total of 8,735 Korean pregnant women were identified at two hospitals between 2014 and 2016. Among them, 2,038 women participated in the prospective cohort to investigate pregnancy outcomes. Diagnosis of GDM was made via two-step approach with 50-g glucose challenge test for screening followed by diagnostic 2-hour 75-g oral glucose tolerance test. Women were divided into three groups: non-GDM, GDM diagnosed exclusively by the IADPSG criteria, and GDM diagnosed by the CC criteria. Results: The incidence of GDM was 2.1% according to the CC criteria, and 4.1% by the IADPSG criteria. Women diagnosed with GDM by the IADPSG criteria had a higher body mass index (22.0±3.1 kg/m2 vs. 21.0±2.8 kg/m2, P<0.001) and an increased risk of preeclampsia (odds ratio [OR], 6.90; 95% confidence interval [CI], 1.84 to 25.87; P=0.004) compared to non-GDM women. Compared to neonates of the non-GDM group, those of the IADPSG GDM group had an increased risk of being large for gestational age (OR, 2.39; 95% CI, 1.50 to 3.81; P<0.001), macrosomia (OR, 2.53; 95% CI, 1.26 to 5.10; P=0.009), and neonatal hypoglycemia (OR, 3.84; 95% CI, 1.01 to 14.74; P=0.049); they were also at an increased risk of requiring phototherapy (OR, 1.57; 95% CI, 1.07 to 2.31; P=0.022) compared to the non-GDM group. Conclusion: The IADPSG criteria increased the incidence of GDM by nearly three-fold, and women diagnosed with GDM by the IADPSG criteria had an increased risk of adverse pregnancy outcomes in Korea.

Second Trimester Maternal Serum Marker and Adverse Pregnancy Outcome

( Se Eun Cho ),( Yoo Jeong Shin ),( Hyo Jeong Kim ),( Hyun Young Ji ),( Hye Min Kwak ),( Hyun Hwa Cha ),( Suk Joo Choi ),( Soo Young Oh ),( Soo Youn Lee ),( Cheong Rae Roh ),( Jong Hwa Kim ) 대한산부인과학회 2011 Obstetrics & Gynecology Science Vol.54 No.11

Objective The aim of this study is to assess the risk of adverse pregnancy outcome by maternal serum markers in Quad test and to compare the existing cutoff (2.0 MoM) with 95 percentile cutoff generated from our consecutive population in predicting adverse pregnancy outcome. Methods We generated 95 percentile cutoff as our own reference using 3,000 consecutive women who performed Quad test. Except for follow-up loss, fetal aneuploidy and anomaly, 2,598 women were analyzed for the assessment of adverse pregnancy outcome consisted of preeclampsia (PE), preterm birth (<32 weeks), low birth weight and fetal death in utero. Results We confirmed high levels of alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and inhibin A are associated with development of PE, preterm birth, and low birth weight. In general, 95 percentile cutoff corresponded similarly with 2.0 MoM except AFP. Combination of serum markers increased the odds ratio for predicting adverse pregnancy outcome. The women with higher level of both AFP and inhibin A (2.0 ≥ MoM) had 9.8 times higher risk for PE, 24.8 times higher risk for preterm birth, and 5.6 times higher risk for low birth weight. The women with higher level of AFP, hCG, and inhibin A had 8.2 times higher risk for PE, 29.4 times higher risk for preterm birth. Notably, negative predictive value of serum markers for PE and preterm birth are over 98% either in alone and in combination. Conclusion Maternal serum makers either in alone and in combination offer valuable information on the risk assessment of adverse pregnancy outcome.

Comparison of the performance of screening test for gestational diabetes in singleton versus twin pregnancies

( Yun Ji Jung ),( Ja Young Kwon ),( Hee Young Cho ),( Yong Won Park ),( Young Han Kim ) 대한산부인과학회 2015 Obstetrics & Gynecology Science Vol.58 No.6

Objective We compared the performance of the 50-g glucose challenge test (GCT) in singleton versus twin pregnancies and investigated the need for adjusting GCT cutoff values for gestational diabetes mellitus (GDM) in twin pregnancies among Korean women. Methods A retrospective chart review was performed in women who underwent GCT at 24 to 28 weeks’ gestation and delivered in our department between January 2000 and April 2008. GCT performance was compared between singleton and twin pregnancies for an ideal cutoff value of the GCT for GDM screening. Results GCT results were available in 3,578 pregnancies (3,435 singleton and 143 twin pregnancies). The mean GCT value was higher in the twin group than in the singleton group. Women in the twin group had a higher mean GCT value (P=0.043) and a higher incidence of GCT ≥130, ≥135, and ≥140 mg/dL (P=0.014, 0.005, and 0.015, respectively). The false positive rate for GCT ≥140 mg/dL was significantly higher in the twin than in the singleton group (P=0.042). The optimal GCT screening cutoff value appears to be ≥145 mg/dL in twin pregnancies. Conclusion Our study demonstrates that the GCT is associated with a higher false positive rate in twin rather than singleton pregnancies. This study suggests we should consider adjusting the GCT cutoff value for GDM in Korean twin pregnancies.

고위험도 임신군에서 Non-Stress Test의 임상적 의의

박인서(IS Park),김용철(YC Kim),박형무(HM Park),박창서(CS Park),차인식(IS Cha) 대한산부인과학회 1982 Obstetrics & Gynecology Science Vol.25 No.1

1. 1980년 9월 1일부터 1981년 8월 말까지 만 1년간 총 분만은 1,307예이었으며 NST의 시행빈도는 82예(6.27%)로 매우 낮은 비율을 보였으며, NST 시행군의 평균 연령은 26.7세, 평균 분만력은 1.4였다. 2. NST 시행군 82예의 적응증은 중증 임신중독증 27예, 과숙아 25예, 경증 임신중독증 11예의 순이었다. 3. 82예의 초회 NST 시행시의 평균재태 기간은 37.9주였다. 4. NST의 판독 결과 78회에서 반응성을 보였으며 무반응성은 6예(6.52)였다. 5. NST에 따른 신생아 Apgar 수치는 반응성인 경우 3미만이 없었으나 무반응성 4예 중 1예에서 심한 태아절박상태(3미만)을 보여 주고 있다. 6. 분만 방법은 질식분만이 68예, 제왕절개군은 14예(17.07%)였다. 7. 무반응성 NST 4예 중 NST 시행 결과 2예에서 양성을 보였으며 모두 태아사망을 보였다. 8. 신생아 사망은 NST시행군(92회)중 양성의 NST군(78예)에서는 전무하였으나 4예의 음성 NST군에서는 4명 중 2명 이었다. For the assessment of fetal well-being, a lot of methods such as biochemical, hormonal assay and fetal monitoring were available. Non-stress test is provided particulary important role in cases of high risk pregnancy. Especially it is simple, economic and not harmful to fetomaternal health, and results in wide utilization in the most obstetric services. We studied and reported 92 non-stress test in high risk pregnancy from Sep. 1980 to Aug. 1981 at National Medical Center. The results of these studies were as follows. 1. Total number of deliveries were 1,307 and incidence of NST was 82 (6.27%). 2. Non-stress test was provided for high risk pregnancy includeing hypertensive disorder in pregnancy 38(40.86%), post-date 25(26.88%), premature uterine contraction 9 (6.45%) and others. 3. The mean gestational weeks in NST group was 37.9. 4. Reactive pattern of NST was noted in 78 cases among 92 NST, whereas 6 cases(6.52%) in non-reactive result. 5. Apgar score had a correlation to non-reactive group (1/4 cases-under 3). 6. The cesarean section rate of NST group was 17.07%. 7. Consecutive CST 4 cases of non-reactive group showed positive in half and 2 cases of non-reactive NST was reactive CST. 8. Perinatal death was noted in 2 cases among 4 non-reactive NST group, but zero in reactive NST group.

How Can We Adopt the Glucose Tolerance Test to Facilitate Predicting Pregnancy Outcome in Gestational Diabetes Mellitus?

김경진,김남훈,최지미,김신곤,이경주 대한내분비학회 2021 Endocrinology and metabolism Vol.36 No.5

Background: We investigated how 100-g oral glucose tolerance test (OGTT) results can be used to predict adverse pregnancy outcomes in gestational diabetes mellitus (GDM) patients. Methods: We analyzed 1,059 pregnant women who completed the 100-g OGTT between 24 and 28 weeks of gestation. We compared the risk of adverse pregnancy outcomes according to OGTT patterns by latent profile analysis (LPA), numbers to meet theOGTT criteria, and area under the curve (AUC) of the OGTT graph. Adverse pregnancy outcomes were defined as a composite ofpreterm birth, macrosomia, large for gestational age, low APGAR score at 1 minute, and pregnancy-induced hypertension. Results: Overall, 257 participants were diagnosed with GDM, with a median age of 34 years. An LPA led to three different clusters ofOGTT patterns; however, there were no significant associations between the clusters and adverse pregnancy outcomes after adjustingfor confounders. Notwithstanding, the risk of adverse pregnancy outcome increased with an increase in number to meet the OGTTcriteria (P for trend=0.011); odds ratios in a full adjustment model were 1.27 (95% confidence interval [CI], 0.72 to 2.23), 2.16 (95%CI, 1.21 to 3.85), and 2.32 (95% CI, 0.66 to 8.15) in those meeting the 2, 3, and 4 criteria, respectively. The AUCs of the OGTT curvesalso distinguished the patients at risk of adverse pregnancy outcomes; the larger the AUC, the higher the risk (P for trend=0.007). Conclusion: The total number of abnormal values and calculated AUCs for the 100-g OGTT may facilitate tailored management ofpatients with GDM by predicting adverse pregnancy outcomes.