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Table 1 Performance characteristics of the included studies 2012–2020

From: Novel biomarkers with promising benefits for diagnosis of cervical neoplasia: a systematic review

Authors No. Part Biomarkers Current Status Test platform Sample type Sensitivity Specificity PPV NPV AUC Mean TAT
Farzanehpour et al, 2019 [2] 72 miRNA (miR-9) Not validated RT-qPCR Tissue 64.7% 76.4% 0.71 ≤ 5 h.
Farzanehpour et al. 2019 [2] 72 miRNA (miR-9) Not validated RT-qPCR Serum 52.9% 94.4% 0.85 ≤ 5 h.
Park et al., 2017 [11] 102 miRNA (miR-9) Not validated RT-qPCR Tissue 67.3% 80% 77.7% 70.2% 0.76 ≤ 5 h.
Wentzensen et al, 2012 [12] 673 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 85.5% 59.4% 48.4%% 90.2%% ≤24 h
Zhu et al, 2019 [13] 300 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 98.2% 82.5% 55.2% 99.5%% 0.90 ≤24 h
Areán-Cun., et al, 2018 [14] 1945 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 98% 39% 44.8% 97.5% ≤24 h
Wentzensen et al, 2015 [15] 1509 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 83.4% 58.9% 21% 96.4% ≤24 h
Yu et al, 2016 [16] 231 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 90.9% 79.5% 49.2% 97.6% 0.85 ≤24 h
Tay et al., 2017 [17] 97 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 92.9% 76.7% 88.1% 86.7% 0.85 ≤24 h
Ebisch et al., 2017 [18] 462 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 92% 61% 52% 95% ≤24 h
Hu et al., 2020 [19] 846 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 86.5% 62.5% 28.8% 96.4% ≤24 h
Ordi et al., 2014 [20] 1169 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 90.9% 72.1% 63.9% 93.6% 0.82 ≤24 h
Uijterwaal et al., 2015 [21] 762 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 68.8% 72.8% 25.2% 94.6% ≤24 h
White et al., 2016 [22] 1346 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 75.4% 88.3% 26.6% 97% ≤24 h
Schmitz et al., 2018 [23] 280 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 100% 90.2% 92.3% 100% ≤24 h
Han et al., 2020 [24] 468 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 91.5% 77% 73.9% 92.8% 0.76 ≤24 h
Li et al., 2020 [25] 4070 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 90.9% 67%. 16.5% 99.1% 0.79 ≤24 h
Wang et al., 2020 [26] 4070 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 91.7% 63.5% 29.3% 97.9% ≤24 h
El-Zein et al., 2020 [27] 1649 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 80.7% 69.4% 64% 71.8% ≤24 h
Wentzensen et al, 2019 [28] 3225 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 82.8% 55.7% 24.3% 95% ≤24 h
Ren et al., 2019 [29] 300 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 50% 75.3% 11.1% 96.1% 0.78 ≤24 h
Bergeron, et al., 2015 [30] 27,349 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 94.4% 78.7% 16.3% 99.7% ≤24 h
Polman et al., 2016 [31] 364 p16INK4a / ki-67 Not validated ICC
CINtec PLUS
LBC 69.2% 90.4% 51.9% 95.1% ≤24 h
Ren et al., 2019 [29] 300 HPV E6/E7 mRNA Not validated QuantiVirus
®HPV
LBC 100% 44.3% 10% 100%% 0.59 ≤ 5 h.
Ren et al, 2018 [32] 160 HPV E6/E7 mRNA Not validated QuantiVirus®HPV LBC 90.3% 49.6% 30.1% 95.5% 0.75 ≤ 5 h
Han et al., 2018 [33] 6800 HPV E6/E7 mRNA Not validated QuantiVirus
®HPV
LBC 85.2% 66.7% 72.9% 81% 0.75 ≤ 5 h
Yao et al., 2017 [34] 404 HPV E6/E7 mRNA Not validated QuantiVirus® HPV LBC 89.5% 49% 39% 92.7% 0.72 ≤ 5 h
Zhu et al, 2019 [13] 300 HPV E6/E7 mRNA Not validated QuantiVirus® HPV LBC 87% 42.7% 25% 93.8% 0.70 ≤ 5 h
Bountris et al, 2014 [35] 740 HPV E6/E7 mRNA Not validated NASBA assay LBC 77% 90.2% 68.5% 93.4% ≤ 5 h
Li et al, 2016 [36] 186 HPV E6/E7 mRNA Not validated QuantiVirus® HPV LBC 65% 86.7% 85.9% 66.7% 0.76 ≤ 5 h
Camus et al, 2018 [37] 502 HPV E6/E7 mRNA Not validated qRT-PCR LBC 90% 50% 64% 83% 0.80 ≤ 5 h
Kong et al, 2020 [38] 600 DNA methylation Not validated qPCR LBC 67.7% 94.9% 95.4% 65.5% 0.86 ≤ 5 h
Dong et al, 2020 [39] 1997 DNA methylation Not validated qPCR LBC 92.9% 73% 56.5% 96.4% 0.83 ≤ 5 h
Schmitz et al, 2018 [23] 280 DNA methylation Not validated RT-PCR LBC 59.7% 98% 91.5% 87.3% ≤ 5 h
van Leeuwen et al.,2019 [40] 262 DNA methylation Not validated qPCR LBC 68% 67% 15% 96% ≤ 5 h
De Strooper et al, 2016 [41] 375 DNA methylation Not validated qPCR LBC 70.5% 67.8% 35.5% 90.2% ≤ 5 h
Chujan et al, 2014 [42] 94 DNA methylation Not validated qPCR LBC 83.3% 96.8% 92.6% 92.5% ≤ 5 h
Kottaridi et al, 2017 [43] 151 DNA methylation Not validated qPCR LBC 75.7% 77.5% 74.7% 78.5% 0.81 ≤ 5 h
Leeman et al, 2019 [44] 262 DNA methylation Not validated qPCR LCB 77.8% 69.3% 36.4% 98.3% ≤ 5 h
Chen et al, 2020 [45] 103 SCC-Ag Validated Elisa Serum 80% 100% 100% 82.6% 0.89 ≤ 5ihrs
Zajkowska et al, 2018 [46] 100 SCC-Ag Validated Elisa Serum 78.8% 74% 66.7% 84.1% 0.79 ≤ 5 h
Sidorkiewicz et al., 2019 [5] 85 SCC-Ag Validated Elisa Serum 81.2% 74% 0.79 ≤ 5 h
Lubowicka et al,2020 [47] 89 SCC-Ag Validated Elisa Serum 78.6% 74% 0.79 ≤ 5 h
Zajkowska et al, 2018 [46] 85 M-CSF Not
validated
Elisa Serum 72.7% 86% 77.4% 82.7% 0.79 ≤ 5 h
Lubowicka et al, 2020 [47] 89 M-CSF Not validated Elisa Serum 75% 86% 0.81 ≤ 5 h
Sidorkiewicz et al., 2019 [5] 85 M-CSF Not validated Elisa serum 69.4% 86% 0.81 ≤ 5 h
Ruan et al, 2020 [48] 68 M-CSF Not validated Elisa Serum 87.7% 64.7% 0.75 ≤ 5 h
Będkowska et al., 2015 [49] 110 M-CSF Not validated Elisa Serum 68% 94% 92% 75% 0.86 ≤ 5 h
Lawicki et al, 2016 [50] 100 VEGF Not validated Elisa Serum 56% 96% 86% 82% 0.85 ≤ 5 h
Sidorkiewicz et al.,2019 [5] 85 VEGF Not validated Elisa Serum 81.2% 76% 0.86 ≤ 5 h
Cheng et al., 2013 [51] 109 VEGF Not validated Elisa Serum 83.3% 74.6% 0.83 ≤ 5 h
Urquidi et al, 2012 [52] 127 VEGF Not validated Elisa Urine 83% 87% 0.88 ≤ 5 h
  1. DNA Deoxyribonucleic Acid, HPV E6/7 Human Papilloma Virus Early protein 6/7, mRNA Messenger ribonucleic acid, NPV Negative Predictive Value, RT PCR Reverse Transcriptase Polymerase Chain Reaction, PPV Positive Predictive Value, AUC Area Under Receiver Operating Characteristic Curve, SCC-Ag Squamous Cell Carcinoma Antigen, M-CSF Macrophage Colony Stimulating Factor, VEGF Vascular Endothelial Growth Factor, LBC Liquid Based Cytology, TAT Turnaround Time, miRNA-9 micro ribonucleic acid-9, Elisa Enzyme Linked Immunosorbent Assay. No Part: Number of Participants; ICC Immunocytochemistry; NASBA Nucleic acid sequence based amplification for the identification of E6/E7 mRNA of the HPV types; (−) means not done; Validated: means approved for use; Not validated means investigation in progress