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. 2015 Dec 10;2015(12):CD011984. doi: 10.1002/14651858.CD011984

Bahado‐Singh 1999.

Clinical features and settings High‐risk referral for invasive testing.
Participants 457 participants.
USA.
August 1996 ‐ June 1997.
Pregnant women.
Mean age 37.1 years.
Singleton pregnancies.
15‐24 weeks' gestation.
Study design Prospective cohort study.
Target condition and reference standard(s) Down's syndrome: 13 cases.
Reference standard: amniocentesis.
Index and comparator tests Maternal age.
Urinary ß core fragment (monoclonal antibody B210 assay, 2‐step sandwich method, standardised for creatinine).
Urinary beta core fragment/total urinary oestriol ratio.
Follow‐up 100% karyotyping.
Aim of study To evaluate Down's syndrome screening efficiency of a new algorithm of multiple urinary biochemical and ultrasound markers.
Notes  
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Selective testing of high‐risk women as done in practice.
Acceptable reference standard? 
 All tests Yes Amniocentesis.
Partial verification avoided? 
 All tests Yes All women received a reference standard.
Differential verification avoided? 
 All tests Yes All women received the same reference standard.
Incorporation avoided? 
 All tests Yes Reference standard was independent of the index test.
Reference standard results blinded? 
 All tests No Reference standard interpreted with knowledge of index test results. 
Index test results blinded? 
 All tests Yes Index test interpreted without knowledge of reference standard results. 
Relevant clinical information? 
 All tests Yes Information available as would be in standard clinical practice.
Uninterpretable results reported? 
 All tests No No details given for test failures/uninterpretable measurements.
Withdrawals explained? 
 All tests No No details of withdrawals given.