Laigaard 2003.

Clinical features and settings	Routine screening.
Participants	172 participants (18 cases of Down’s syndrome and 154 controls). Denmark ‐ University hosp1T ITAl. Dates not specified. Pregnant women. Singleton pregnancies. 8‐13 weeks' gestation.
Study design	Case‐control study.
Target condition and reference standard(s)	Down's syndrome: 18 cases. Reference standards: karyotyping, unclear reference standard for controls.
Index and comparator tests	Frozen serum tested for: First trimester ADAM12 (ELISA, 6E6 and 8F8 antibodies).
Follow‐up	No details of follow‐up reported.
Aim of study	To determine whether ADAM12 concentration is a useful indicator of fetal health.
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	Unclear	Unclear reference standard in controls.
Partial verification avoided? All tests	Unclear	Unclear if all women had a reference standard.
Differential verification avoided? All tests	No	Different reference standards used.
Incorporation avoided? All tests	Yes	Reference standard was independent of the index test.
Reference standard results blinded? All tests	Yes	Reference standard interpreted without knowledge of index test results.
Index test results blinded? All tests	Unclear	Unclear if 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.