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. 2019 Aug 1;2019(8):CD011871. doi: 10.1002/14651858.CD011871.pub2

3. Overview of characteristics of included studies.

Study ID Study design Region Sample size Prevalence Sensitivity Specificity Index testa Original reference of index test method Target gene/primera Threshold Timing (DPO)a Sample typea Reference standard Sample for MAT
Agampodi 2012 CC1 Sri Lanka 105 21.7% 51.0% 98.2% qPCR Smythe 2002 rrs U 1–10 Whole blood MAT Paired only
18.4% 98.2% qPCR Smythe 2002 rrs U 1–10 Serum
Agampodi 2016 CS Sri Lanka 96 43.8% 27.3% 25.0% qPCR Smythe 2002 rrs U 3–7 Blood/serum MAT Single + paired
Ahmed 2009 CS Netherlands 75 19.5% 100% 100% qPCR Ahmed 2009 secY 35 Ct 1–4 Blood/serum MAT OR IgM ELISA OR Culture Single + paired
62 68.8% 100% qPCR Ahmed 2009 secY 35 Ct 5–10 Blood/serum
133 88.5% 100% qPCR Ahmed 2009 secY 35 Ct 1–10 Blood/serum
Ananyina 2000 CC2 Russia and China 158 U 68.0% 100% cPCR Gravekamp 1993 G1/G2 and B64‐I/B64‐II primers NA U Serum MAT Single + paired
Backstedt 2015 CS Brazil 25 72.0% 27.8% 71.4% qPCR Stoddard 2009 lipL32 U U Whole blood MAT OR culture Single + paired
55.6% 14.3% qPCR Backstedt 2015 rrs U U Whole blood
Biscornet 2017 CS Seychelles 223 13.9% 35.5% 90.1% qPCR Smythe 2002 rrs 35 Ct U Serum MAT OR IgM ELISA Single + paired
Blanco 2014 CS Brazil 521 5.4% 14.3% 100% cPCR Merien 1992 rrs NA U Serum MAT Single + paired
85.7% 100% N PCR Merien 1992 rrs NA U Serum
Cardona 2008 CS Venezuela 73 27.4% 20.0% 77.4% cPCR Gravekamp 1993 G1/G2 and B64‐I/B64‐II primers NA U Serum MAT Single + paired
45.0% 71.7% cPCR Gravekamp 1993 G1/G2 and B64‐I/B64‐II primers NA U Urine
Céspedes 2007 CS Peru 118 22.0% 55.4% 100% cPCR Merien 1992 rrs NA 1–7 Whole blood MAT OR IgM ELISA OR culture Single + paired
Chandrasiri 2010 CS Sri Lanka 59 11.8% 14.3% 86.5% cPCR U G1/G2 primers NA U Whole blood MAT Single
Chaurasia 2018 CS India 29 79.3% 100% 66.7% ELISA (LipL32) Chaurasia 2018 NA U U Urine MAT Single
91.3% 50.0% ELISA (Fla1) Chaurasia 2018 NA U U Urine
78.3% 83.3% ELISA (LipL41) Chaurasia 2018 NA U U Urine
91.3% 66.7% ELISA (HbpA) Chaurasia 2018 NA U U Urine
100% 66.7% ELISA (SphCD210) Chaurasia 2018 NA U U Urine
91.3% 66.7% ELISA (Sph2) Chaurasia 2018 NA U U Urine
39.1% 83.3% ELISA (Sph4) Chaurasia 2018 NA U U Urine
De Abreu Fonseca 2006 CC2 Brazil 80 U 38.3% 100% cPCR Gravekamp 1993/Kee 1994 G1/G2 and LP1/LP2 primers NA U Whole blood MAT OR culture Single + paired
36.7% 100% cPCR Gravekamp 1993/Kee 1994 G1/G2 and LP1/LP2 primers NA U Urine
Denipitiya 2016 CS Sri Lanka 111 58.6% 67.7% 91.3% qPCR Ahmed 2009 secY 35 Ct 1–5 Whole blood MAT Single + paired
Fan 1999 CS China 15 33.3% 100% 80.0% cPCR Fan 1999 rrs NA U Serum MAT U
Gokmen 2016 CS Turkey 47 44.7% 90.5% 42.3% N PCR Bomfim 2008 lipL32 NA U Serum MAT Single
95.2% 42.3% N PCR Merien 1992 rrs NA U Serum
Gonzalez 2013 CS Uruguay 183 46.4% 30.6% 100% qPCR Stoddard 2009 and Bourhahy 2001 lipL32 U U Serum MAT Paired only
Gravekamp 1993 U Netherlands and Barbados 119 U 49.4% 100% cPCR Gravekamp 1993 G1/G2 and LP1/LP2 primers NA U Serum MAT OR IgM ELISA U
Kitashoji 2015 CS Philippines 287 46.0% 14.4% 83.2% LAMP Koizumi 2012 rrs NA 6.5 Plasma MAT Single + paired
14.1% 90.6% LAMP Koizumi 2012 rrs NA U Urine
Koizumi 2009 CS Sri Lanka 107 24.3% 0.0% 96.3% N PCR Kawabata 2001/mod:Koizumi 2008 flaB NA 7 Serum MAT Single only
Merien 2005 CS Oceania 51 33.3% 70.6% 61.8% N PCR Merien 1992 rrs NA 5 Serum MAT Single + paired
70.6% 61.8% qPCR Merien 2005 LFB1‐F/LFB1‐R primers U 5 Serum
Ooteman 2006 CS Brazil 125 37.6% 36.2% 70.5% cPCR Gravekamp 1993 G1/G2 primers NA U Serum MAT Single + paired
Pakoa 2018 CS Vanuatu 130 11.5% 0% 97.4% qPCR Stoddard 2009 lipL32 U U Serum MAT Single
Riediger 2007 CS U 66 22.7% 46.7% 76.5% cPCR Gravekamp 1993 G1/G2 and B64‐I/B64‐II primers NA U Whole blood MAT Single + paired
40.0% 80.4% cPCR Gravekamp 1993 G1/G2 and B64‐I/B64‐II primers NA U Urine
Riediger 2017 CS Brazil 150 84.7% 60.6% 56.2% qPCR Stoddard 2009 lipL32 40 Ct U Whole blood MAT OR culture Single + paired
29.1% 87.0% qPCR Stoddard 2009 lipL32 40 Ct U Serum
Saengjaruk 2002 CC2 Thailand 43 U 64.0% 100% dot‐ELISA Saengjaruk 2002 NA NA 5 Urine Culture NA
Samsonova 1997 CC2 China and Russia 75 U 66.0% 96.4% cPCR Gravekamp 1993 G1/G2 and B64‐I/B64‐II primers NA U Serum MAT U
Seng 2007 CS Cambodia 121 3.3% 75.0% 94.0% cPCR 2× U rrl (23S) NA (1) 14, (2) 35 Serum MAT OR culture Single + paired
Sonthayanon 2013 CC1 Thailand 250 31.8% 59.0% 92.0% qPCR Slack 2007 rrs U U Whole blood MAT OR culture Single + paired
Sukmark 2018 CS Thailand 202 42.6% 22.1% 77.6% cPCR Stoddard 2009 lipL32 NA Cases 4, controls 3 Urine MAT OR culture Single + paired
Thaipadunpanit/ Sonthayanon 2011 CC1 Thailand 266 31.8% 55.6% 89.5% qPCR Slack 2007 rrs U 5 Whole blood MAT OR culture Paired only
42.9% 93.2% qPCR Stoddard 2009 lipL32 U 5 Whole blood
43.6% 83.5% LAMP Sonthayanon 2011 rrs NA 5 Whole blood
37.6% 90.2% LAMP Lin 2009 lipL41 NA 5 Whole blood
Vanasco 2016 CC1 Argentina 188 35.5% 29.9% 81.0% qPCR Stoddard 2009 lipL32 40 Ct 5 Serum/blood MAT OR IgM ELISA Single + paired
13.4% 88.4% cPCR Stoddard 2009 lipL32 NA 5 Serum/blood
Villumsen 2012 BC CS Denmark 29 24.1% 85.7% 100% qPCR Villumsen 2012 lipL32 U U Blood culture MAT Single + paired
100% 95.5% qPCR Smythe 2002 rrs U U Blood culture
Villumsen 2012 U CS Denmark 54 5.6% 100% 98.0% qPCR Villumsen 2012 lipL32 U U Urine MAT Single + paired
100% 98.0% qPCR Smythe 2002 rrs U U Urine
Waggoner 2014 CS Brazil 55 10.9% 100% 4.1% qPCR Waggoner 2014 rrs 45 Ct 8 Plasma/serum MAT Single only
100% 0.0% qPCR (UFI Assay) Waggoner 2014 rrs 45 Ct Range 1–19 Plasma/serum
Waggoner 2015 CC1 Brazil 478 NA 9.1% 92.8% qPCR (UFI Assay) Waggoner 2014 rrs 45 Ct U Serum MAT Single only
Wangroongsarb 2005 CS Thailand 93 16.1% 80.0% 96.2% cPCR U/Kawabata 2001 rrs / flaB NA U Whole blood MAT OR culture Paired
Widiyanti 2013 CS Philippines 44 63.6% 57.1% 56.3% cPCR Kawabata 2001 flaB NA 5.5 Urine MAT Single only
89.3% 62.5% Dipstick Widyanti 2013 NA NA 5.5 Urine
96.4% 56.3% ICG‐LFA Widiyanti 2013 NA NA 5.5 Urine
Woods 2018 CS Laos 766 4.4% 9.4% 98.5% qPCR Slack 2007 rrs 40 Ct 5 Serum MAT OR culture Single + paired
3.0% 99.0% qPCR Slack 2007 rrs 40 Ct 5 Buffy coat
17.2% 90.1% qPCR Slack 2007 rrs 40 Ct 5 Urine
9.4% 98.8% qPCR Woods 2018 rrs/lipL32 45 Ct 5 Serum
12.1% 99.0% qPCR Woods 2018 rrs/lipL32 45 Ct 5 Buffy coat
13.8% 99.0% qPCR Woods 2018 rrs/lipL32 45 Ct 5 Urine
Wu 1996 CS China 19 47.4% 100% 0.0% cPCR Wu 1993 rrs NA U Serum MAT OR culture U
Yersin 1998 CS Seychelles 112 53.6% 46.7% 96.2% cPCR 2× Merien 1995 rrs NA (1) 3.9–4.5
(2) ≥ 14		 Serum MAT Paired only
Zhang 1992 U China 175 75.4% 100% 32.6% cPCR Zhang 1992 rrl (23S) NA 1–5 Serum MAT OR Culture Paired only

Summary table of included studies. 95% confidence intervals are not shown. Timing of sample collection (DPO of symptoms) is presented as median numbers or range or interquartile range.
 aUnderlined are the direct comparisons of index tests.
 CC1: single‐gate case‐control study; CC2: two‐gate case‐control study; CS: cross‐sectional study; Ct: threshold cycle; DPO: days postonset; EDTA: ; ICG‐LFA: immunochromatography‐based lateral flow assay; IgM ELISA: immunoglobulin G enzyme‐linked immunosorbent assay; LAMP: loop‐mediated isothermal amplification; MAT: microscopic agglutination test; MAT OR … OR …: a positive result of any one of these tests is considered a leptospirosis case; PCR: polymerase chain reaction; cPCR: conventional PCR; N PCR: nested PCR; NA: not applicable; cPCR 2x: conventional PCR performed twice at different moments in time; qPCR: real‐time PCR; U: unknown.