Contingent triple‐screening for Down syndrome in the second trimester: a feasibility study in Mainland Chinese population

Xie, Zhenwei; Lü, Shiming; Li, Hui

doi:10.1002/pd.2412

Cited by 11 publications

(13 citation statements)

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“…6 , 7 By contrast, our double screening detection rate of 69.6% is higher than rates reported in previous studies examining second trimester double screening in Chinese women (50 to 60%). 4 , 5 The explanation for a seemingly higher detection rate in the present study is unclear, and we are continuing to monitor the results of second trimester double screening for DS to confirm whether the detection rate reported is real or a statistical anomaly. It is worth noting that we found that the second trimester double screening detection rate was markedly lower (56.5%) when the false-positive rate was fixed at 3.0%.…”

Section: Discussionmentioning

confidence: 53%

“…Serum was isolated at room temperature and stored at 220 8C for measurement of free b-hCG (first and second trimester), PAPP-A (first trimester), and AFP (second trimester) by dissociation-enhanced lanthanide fluorescence immunoassay (DELFIA1235: Perkin Elmer, Waltham, MA). Fetal NT thickness was measured during the first trimester using ultrasound (2)(3)(4)(5). Measurements were made by three trained physicians (note: these physicians were not Fetal Medicine Foundation trained in assessing fetal NT thickness).…”

Section: Sampling and Sample Analysismentioning

confidence: 99%

“…2 Second trimester DS screening typically involves the assessment of maternal serum β-hCG, alphafetoprotein (AFP), unconjugated oestriol (triple screening), and inhibin A (quadruple screening) concentrations 3 or the assessment of β-hCG and AFP (double screening) concentrations in some countries, including China. 4 , 5 Integrated screening involves performing assessments during both the first and second trimester and thereafter assessing DS risk. 3 , 6 Integrated screening has been reported to be associated with the highest DS detection rates (88% to 96%; 2% to 5% false-positive rates), 6–9 followed by first trimester screening (85% to 94%; 3% to 5% false-positive rates), 6,7,10 and then second trimester quadruple (81% to 85%; 5% to 6% false-positive rates) 6 , 7 and triple (69% to 85%; 5% to 9% false-positive rates) 6 , 7 screening.…”

Section: Introductionmentioning

confidence: 99%

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First trimester, second trimester, and integrated screening for Down's syndrome in China

et al. 2012

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Section: Discussionmentioning

confidence: 53%

Section: Sampling and Sample Analysismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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First trimester, second trimester, and integrated screening for Down's syndrome in China

et al. 2012

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“…All studies except one were cohort studies, among which 85.7% were conducted retrospectively and 4.2% were multicentre. The majority of included studies (92.9%) were conducted in Mainland China.…”

Section: Resultsmentioning

confidence: 99%

Performance of prenatal screening using maternal serum and ultrasound markers for Down syndrome in Chinese women: a systematic review and meta‐analysis

Rosenthal

Wang

et al. 2016

BJOG

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Background Controversies about the performance of conventional prenatal screening using maternal serum and ultrasound markers (PSMSUM) in detecting Down syndrome (DS) have been raised as a result of a recently available noninvasive prenatal test based on cell-free fetal DNA sequencing.Objectives To evaluate the screening performance of PSMSUM in detecting DS in Chinese women.Search strategy An exhaustive literature search of MEDLINE, Embase, the Cochrane Library, ISI Web of Science and China BioMedical Disc.Selection criteria Primary studies, published from January 2004 to November 2014, which examined the screening accuracy of PSMSUM in pregnant Chinese women, compared with a reference standard, either chromosomal verification or inspection of the newborn.Data collection and analysis Data were extracted as screening positive/negative results for Down and non-Down syndrome pregnancies, allowing estimation of sensitivities and specificities. Risks of bias within and across studies were assessed. Screening accuracy measures were pooled using a bivariate random effects regression model.Main results Seventy-eight studies, involving six categories of PSMSUM, were included. Second-trimester double serum [pooled sensitivity (SEN) = 0.80, pooled specificity (SPE) = 0.95] and triple-serum (pooled SEN = 0.79, pooled SPE = 0.96) screening were the predominant PSMSUM methods. The screening performances of these methods achieved the national standard but varied enormously across studies. First-trimester combined screening (pooled SEN = 0.92, pooled SPE = 0.93) and secondtrimester quadruple serum screening (median SEN = 0.86, median SPE = 0.96) performed better, but were rarely used.Author's conclusions Second-trimester maternal serum screening has the potential to achieve satisfactory screening performance in middle-and low-income countries. The reported enormous range in screening performance of second-trimester PSMSUM calls for urgent implementation of methods for performance optimization.Keywords Down syndrome, prenatal screening, systematic review, trisomy 21.

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“…The objective of prenatal screening and diagnosis is to identify those women at the increased risk for an affected pregnancy and to maximize the options available to them ( 2 ). Maternal serum prenatal screening in second trimester is a screening test that collects the peripheral blood of pregnant women at 15-20 weeks (+ 6 days), combining the age-related risk of maternal for an affected pregnancy with the risks associated with the concentrations of biomarkers ( 3 ). The serum biomarkers involves alpha fetoprotein (AFP), total human chorionic gonadotropin (t-hCG), β-hCG, unconjugated estriol (uE3), free-β-hCG, and Inhibin-A (Inh-A), which have been used in combined forms to produce double (AFP and t-hCG/β-hCG/free β-hCG), triple (AFP, uE3, and t-hCG/β-hCG/free β-hCG) and quadruple (AFP, uE3, Inh-A, and t-hCG/β-hCG/free β-hCG) tests ( 4 ).…”

Section: Introductionmentioning

confidence: 99%

Proficiency testing of maternal serum prenatal screening in second trimester in China, 2015

Zhang

Wang

et al. 2017

Biochem Med

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IntroductionPrenatal screening and diagnosis is important for the detection of birth defects and genetic diseases. The nationwide proficiency testing (PT) of maternal serum prenatal screening in second trimester in China has been launched since 2003 and partly reflected the performance of screening laboratories. This study analysed the 2015 PT results to examine the performance of clinical laboratories and different platforms.Materials and methodsFifteen lyophilized samples with different concentrations divided into three panels, were distributed to 613 clinical laboratories in 2015. Acceptable performance was defined as scores more than 80% of acceptable responses with the evaluation criterion of ± 30%. The robust coefficient of variation (CV) was also analysed. Chi-square (χ2) test was used to compare the acceptable performance while Kruskal-Wallis test and Mann-Whitney test were applied to compare the robust CV among analytes and mainstream platforms.ResultsOverall, 605, 61, 214, 416, 303 laboratories submitted effective results for alpha fetoprotein (AFP), total human chorionic gonadotropin (t-hCG), β-hCG, unconjugated estriol (uE3) and free β-hCG. The acceptable performances of AFP (μg/L), AFP (KIU/L), t-hCG, β-hCG, uE3, and free β-hCG were 98.45%, 99.24%, 95.58%, 98.72%, 94.50%, and 98.66%, respectively. The χ2 test indicated significant differences existed in the acceptable performances among different analytes and platforms for uE3. Kruskal-Wallis test and Mann-Whitney test suggested the robust CV differed significantly in different analytes and platforms.ConclusionsThe majority of results were acceptable. However, further effort is needed to achieve the standardization and harmonization among analytes and various platforms, particularly for uE3.

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Contingent triple‐screening for Down syndrome in the second trimester: a feasibility study in Mainland Chinese population

Abstract: Second-trimester maternal serum contingent triple-screening could be effective and suitable for prenatal care in Mainland China. Governments and Health Agencies of other developing countries may also find this strategy cost-effective.

Cited by 11 publications

References 13 publications

First trimester, second trimester, and integrated screening for Down's syndrome in China

First trimester, second trimester, and integrated screening for Down's syndrome in China

Performance of prenatal screening using maternal serum and ultrasound markers for Down syndrome in Chinese women: a systematic review and meta‐analysis

Proficiency testing of maternal serum prenatal screening in second trimester in China, 2015

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