Baviera 2010.
| Clinical features and settings | Routine screening | |
| Participants | 579 participants: 17 cases and 562 controls matched for gestational age Italy ‐ single centre December 2006 ‐ May 2009 Pregnant women Mean maternal age 35.3 years (cases) and 30.4 years (controls) Singleton pregnancies 7‐10 and 14‐17 weeks' gestation |
|
| Study design | Case‐control study | |
| Target condition and reference standard(s) | Down's syndrome: 17 cases (14 identified by amniocentesis, 3 from follow‐up to birth) Reference standard: amniocentesis or follow‐up to birth |
|
| Index and comparator tests | Frozen serum samples tested for: First trimester and second trimester ADAM12s (time resolved fluorescence immunoassay, DELFIA assay kit, Perkin Elmer Life and Analytical Sciences) First trimester PAPP‐A (details not reported) Second trimester AFP, uE3 and hCG (details not reported) |
|
| Follow‐up | Details of follow‐up not reported | |
| Aim of study | To demonstrate the potential value of repeated measures of ADAM12s for the screening of Down's syndrome | |
| Test characteristics | ||
| Reference standard used | ||
| Notes | ||
| Table of Methodological Quality | ||
| Item | Authors' judgement | Description |
| Representative spectrum? All tests | Yes | Routine screening of typical pregnant population |
| Acceptable reference standard? All tests | Yes | Karyotyping or follow‐up to birth |
| Partial verification avoided? All tests | Yes | All women received a reference standard |
| Differential verification avoided? All tests | No | Choice of reference standard depended on index test results |
| 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 |