. 2022 Nov 24;8(11):e11829. doi: 10.1016/j.heliyon.2022.e11829

Table 1.

Summary of studies included in the review.

Study first author, number	Reference number	Year of Publication	Study Locale	Reference Test	Case Definition	ICT Kit Evaluated	Sample Size	Prevalence (%)
Dittrich et al.	[23]	2018	Laos	MAT, qPCR, and culture	MAT titer ≥1:400	"Test-it” (Life Assay, South Africa)	695	5.6
					Four-fold rise in titer in paired samples	"Test-it” (Life Assay, South Africa)
					Positive culture	"Dual Path Platform (DPP)” (Chembio, Medford, NY)
					Positive Leptospira DNA	"Dual Path Platform (DPP)” (Chembio, Medford, NY)
Dinhuzen et al.	[24]	2021	Thailand	MAT, qPCR, and culture	MAT titer ≥1:400	"Medical Science Public Health” (Department of Medical Sciences, Ministry of Public Health, Thailand); "Leptocheck-WB” (Zephyr Biomedicals, India); "TRUSTLine” (Athenese-Dx, India)	99	56.6
					Four-fold rise in titer in paired samples
					Positive culture
					Positive Leptospira DNA
Doungchawee et al.	[16]	2017	Thailand	MAT and Culture	Positive culture	LEPKit	168	47.6
					MAT titer ≥1:400 in single sample
					Seroconversion from negative to a titer of ≥1:100
					Four-fold rise in titer in paired samples
Bandara et al.	[25]	2016	Sri Lanka	MAT and PCR	Positive Leptospira DNA	"Leptocheck-WB” (Zephyr Biomedicals, India	75	62.9
Bandara et al.	[25]	2016	Sri Lanka	MAT and PCR	MAT titer ≥1:400 in single sample	"Leptocheck-WB” (Zephyr Biomedicals, India	75	62.9
Alia et al.	[26]	2019	Malaysia	MAT, culture, qPCR, and IHC	MAT titer ≥1:400 in single sample	"Leptocheck-WB” (Zephyr Biomedicals, India); "ImmuneMed Leptospira IgM Duo (ImmunMed Inc., Republic of Korea)	P = 50	P = 38.0
					Paired sample with four-fold or greater rise			P = 38.0
					Positive Leptospira DNA			R = 71.9
					Positive culture		R = 135
					Positive IHC in tissue samples		R = 135
Chang et al.	[28]	2014	Malaysia	MAT, and PCR	MAT titer ≥1:400 in single sample	“VISITEC®-LEPTO” (Omega Diagnostics, Scotland, UK)	Case = 113	N/A
Chang et al.	[28]	2014	Malaysia	MAT, and PCR	Positive Leptospira DNA	“VISITEC®-LEPTO” (Omega Diagnostics, Scotland, UK)	Control = 70	N/A
Podgoršek et al.	[29]	2015	Slovenia	MAT	MAT titer ≥1:100 in single sample	"Leptocheck-WB” (Zephyr Biomedicals, India)	590	2.2
Effler et al.	[30]	2002	Hawaii	MAT and Culture	Positive culture	“LEPTO Dipstick” (Organon-Teknika, Ltd., The Netherlands)	236	22.0
Effler et al.	[30]	2002	Hawaii	MAT and Culture	Four-fold rise in titer in paired samples	“LEPTO Dipstick” (Organon-Teknika, Ltd., The Netherlands)	236	22.0
Niloofa et al.	[31]	2015	Sri Lanka	MAT	MAT titer ≥1:400 in single sample	"Leptocheck-WB” (Zephyr Biomedicals, India)	888	39.8
					Seroconversion from negative to a titer of ≥1:100
					Four-fold rise in titer in paired samples
Rao et al.	[32]	2019	Malaysia	MAT	MAT titer ≥1:400 in single sample	"Leptocheck-WB” (Zephyr Biomedicals, India)	142	46.5
Rao et al.	[32]	2019	Malaysia	MAT	Four-fold rise in titer in paired samples	"Leptocheck-WB” (Zephyr Biomedicals, India)	142	46.5
Bajani et al.	[33]	2003	Thailand, Palau, and United States	Culture, IHC, and MAT	Positive culture	LDS Kit (Royal Tropical Institute, The Netherlands)	Case = 133; Control = 642	N/A
					Positive IHC in tissue samples
					Four-fold rise in titer in paired samples
Amran et al.	[34]	2018	Malaysia	MAT	MAT titer ≥1:400 in single sample	"ImmuneMed Leptospira IgM Duo (ImmunMed Inc., Republic of Korea)	197	47.2
Amran et al.	[34]	2018	Malaysia	MAT	Four-fold rise in titer in paired samples		197	47.2
Sehgal et al.	[35]	2003	India	Culture and MAT	Positive culture	Lepto Lateral Flow; Lepto Dipstick	117	59.8
					Seroconversion from negative to a titer of ≥1:100
					Four-fold rise in titer in paired samples
					MAT titer ≥1:400 in single sample
Eugene et al.^b	[36]	2015	Sri Lanka	MAT	MAT titer ≥1:400 in single sample	"Leptocheck-WB” (Zephyr Biomedicals, India)	83	48.1
Vanithamani et al.	[37]	2015	India	MAT, IgM ELISA, and Culture	Positive culture	LPS-specific Immunochromatographic Lateral Flow Assay	Case = 120; Control = 295	N/A
					Seroconversion from negative to a titer of ≥1:160
					Four-fold rise in titer in paired samples
					Titer of ≥1:160 in IgM ELISA
Blacksell et al.	[38]	2006	Laos	MAT	Four-fold rise in titer in paired samples	“Leptotek lateral flow” (Organon-Teknika, The Netherlands)	186	12.4
Blacksell et al.	[38]	2006	Laos	MAT	MAT titer ≥1:400 in single sample	“Leptotek lateral flow” (Organon-Teknika, The Netherlands)	186	12.4
Smits et al., 1	[39]	1999	Barbados	Culture and MAT	Positive culture	Lepto Dipstick	134	32.8
					Four-fold rise in titer in paired samples
					MAT titer ≥1:800 in single sample
			India	MAT	MAT titer ≥1:80 in single sample		163	38.7
			Kenya	MAT	MAT titer ≥1:320 in single sample		ND
			New Zealand	Culture and MAT	Positive culture		144	23.6
					Four-fold rise in titer in paired samples
					MAT titer ≥1:400 in single sample
			Philippines	MAT	MAT titer ≥1:400 in single sample		71	74.6
			Puerto Rico	MAT	Four-fold rise in titer in paired samples		104	6.7
			Puerto Rico	MAT	MAT titer ≥1:400 in single sample		104	6.7
			Surinam (Study 1)	MAT	MAT titer ≥1:320 in single sample		186	27.4
			Surinam (Study 2)	MAT	MAT titer ≥1:320 in single sample		70	62.9
			The Netherlands	Culture and MAT	Positive culture		428	4.0
					MAT titer ≥1:160 in single sample
					Four-fold rise in titer in paired samples with a minimum titer of 1:160 for the 2nd sample
			Thailand	MAT	MAT titer ≥1:320 in single sample		127	13.4
			Thailand	MAT	Four-fold rise in titer in paired samples with a minimum titer of 1:320 for the 2nd sample		127	13.4
			Hawaii	Culture and MAT	Positive culture		201	16.9
			Hawaii	Culture and MAT	Four-fold rise in titer in paired samples with a minimum titer of 1:200 for the 2nd sample		201	16.9
			Russia	MAT and slide agglutination test	MAT titer ≥1:100 in single sample		87	52.9
			Russia	MAT and slide agglutination test	Positive slide agglutination test		87	52.9
			Seychelles	MAT	Four-fold rise in titer in paired samples with a minimum titer of 1:100 for the 2nd sample		118	63.6
Smits et al., 2	[40]	2001	Hawaii, Indonesia, The Netherlands, Seychelles	MAT	Four-fold rise in titer in paired samples	LEPTO Lateral-flow Assay	Case = 135; Control = 285	N/A
Smits et al., 2	[40]	2001	Hawaii, Indonesia, The Netherlands, Seychelles	MAT	MAT titer ≥1:160 in single sample	LEPTO Lateral-flow Assay	Case = 135; Control = 285	N/A
Goris et al.	[41]	2013	The Netherlands	MAT, IgM ELISA and Culture	Positive culture	“LEPTOTek Lateral-flow Assay” (Organon Teknika B.V. Boxtel, The Netherlands); "Leptocheck-WB” (Zephyr Biomedicals, India)	5144	7.1
					Four-fold rise in titer in paired samples (at least 2 days apart) in MAT or IgM ELISA
					Titer ≥1:160 in single sample in MAT or IgM ELISA
Silpasakorn et al.	[42]	2011	Thailand	MAT and Culture	Positive culture	SD Leptospira ICT (Standard Diagnostics Inc, Korea)	Case = 89	N/A
Silpasakorn et al.	[42]	2011	Thailand	MAT and Culture	Four-fold rise in titer in paired samples	SD Leptospira ICT (Standard Diagnostics Inc, Korea)	Control = 72	N/A
Panwala et al., 1	[43]	2015	India	MAT	MAT titer ≥1:100 in single sample	"Leptocheck-WB” (Zephyr Biomedicals, India)	100	28.0
Panwala et al., 2	[44]	2011	India	Culture, MAT and IgM ELISA	Positive culture	"Leptocheck-WB” (Zephyr Biomedicals, India)	Case = 130; Control = 310	N/A
					Seroconversion from negative to a titer of ≥1:100 using MAT or IgM ELISA
					Four-fold rise in titer in paired samples using IgM ELISA or MAT
					Titer of >1:100 in IgM ELISA and >200 in MAT

P—Prospective data; R—Retrospective data; N/A—Not applicable; ND—No data.