Table 1

Main characteristics of selected studies

Study no. (ref)Patients no. (OC vs BGD)Company/platform of HE4 assayCompany/platform of CA-125 assayEnrolling centreStudy designData presentation
1 (18)66 vs 257Abbott/ArchitectAbbott/ArchitectGCSBinary data
2 (19)113* vs 165†Abbott/ArchitectAbbott/ArchitectGOCSBinary data
3 (20)125‡ vs 289Abbott/ArchitectAbbott/ArchitectGCCBinary data
4 (21)111§ vs 285¶Abbott/ArchitectAbbott/ArchitectGCSBinary data
5 (22)34** vs 195Abbott/ArchitectAbbott/ArchitectGPCTBinary data
6 (23)52 vs 150CanAg ELISACanAg ELISAGOCSBinary data
7 (24)96 vs 90Abbott/Architect— Fujirebio ELISAAbbott/Architect— Fujirebio ELISAGOCSMeans
8 (25)29 vs 71Fujirebio ELISAFujirebio ELISAGOCSBinary data
9 (26)161†† vs 228‡‡Fujirebio ELISAFujirebio ELISAGOPCTBinary data
10 (27)55 vs 49Fujirebio ELISAFujirebio ELISAGCCBinary data
11 (28)149 vs 350Luminex Multiplexed ELISALuminex Multiplexed ELISAGOPCTBinary data
12 (29)37 vs 50CanAg ELISACanAg ELISAGCSBinary data
13 (30)41§§ vs 24Fujirebio ELISARoche Diagnostics/Cobas e411GCCBinary data
14 (31)32 vs 86Fujirebio ELISARadim RIAGOCCBinary data
15 (32)227¶¶ vs 158***Luminex Multiplexed ELISALuminex Multiplexed ELISAGCSBinary data
16 (33)14 vs 69†††Fujirebio ELISAFujirebio ELISAGCSMeans
  • *26 pre- and 87 post-menopause.

  • †69 pre- and 96 post-menopause.

  • ‡24 early (International Federation of Gynaecology and Obstetrics (FIGO) stage I/II) and 101 late (FIGO stage III/IV).

  • §27 pre- and 84 post-menopause.

  • ¶226 pre- and 59 post-menopause.

  • **Pre-menopausal women only.

  • ††42 pre- and 119 post-menopause.

  • ‡‡142 pre- and 86 post-menopause.

  • §§13 early (FIGO stage I/II) and 28 late (FIGO stage III/IV).

  • ¶¶58 pre- and 169 post-menopause (63 early (FIGO stage I/II) and 106 late (FIGO stage III/IV)).

  • ***18 pre- and 140 post-menopause.

  • †††Ovarian endometriosis only.

  • BGD, benign gynaecological disease; CC, case–control study; CS, cross-sectional study; OC, ovarian cancer; G, gynaecology; GO, gynaecology–oncology; HE4, human epididymis protein 4; PCT, prospective clinical trial; RIA, radioimmunoassay.