Background: Direct agglutination test (DAT) as a simple, accurate and reliable method, has been widely used for serodiagnosis of visceral leishmaniasis (VL) during the last three decades. The present study is a systematic review and meta-analysis to evaluate the diagnostic accuracy of DAT for serodiagnosis of human VL.
Methods: Electronic databases, including MEDLINE (via PubMed), SCOPUS, Web of Science, SID and Mag Iran (two Persian scientific search engines) were searched from December 2004 to April 2019. We determined the pooled sensitivity and specificity rates of DAT for the diagnosis of human VL, calculated positive and negative likelihood ratios (LR+ and LR-), and constructed summary receiver operating characteristic (ROC) curves parameters across the eligible studies.
Results: Of the 2928 records identified in the mentioned electronic databases and after examining reference lists of articles, 24 articles met inclusion criteria and were enrolled in the systematic review and out of them 20 records qualified for meta-analysis. The pooled sensitivity and specificity rates of DAT was 96% [95% CI, 92–98] and 98% [95 % CI, 86–99], respectively. The likelihood ratio of a positive test (LR+) was found to be 21 [CI95%, 6.6–66.5] and the likelihood ratio of a negative test (LR−) was found to be 0.04 [(CI95%, 0.02–0.08]. The combined estimate of the diagnostic odds ratio for DAT was high [467 (CI95%, 114-1912]). We found that the summary receiver operating characteristic curve (SROC) is positioned near the upper left corner of the curve and the area under curve (AUC) was 0.98 (95% CI, 0.97 to 0.99).
Conclusion: Referring to our analysis, we determined that DAT can be considered as a valuable tool for the serodiagnosis of human VL with high sensitivity and specificity. As DAT is a simple, accurate and efficient serological test, it can be recommended for serodiagnosis of human VL particularly in endemic areas.

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Posted 04 Nov, 2020
On 30 Oct, 2020
On 29 Oct, 2020
On 22 Oct, 2020
On 29 Sep, 2020
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On 08 Sep, 2020
Received 01 Sep, 2020
Received 26 Aug, 2020
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Received 13 Aug, 2020
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On 09 Aug, 2020
On 09 Aug, 2020
On 15 Jul, 2020
Received 13 Jul, 2020
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On 22 Jun, 2020
Received 08 Jun, 2020
On 15 May, 2020
Received 26 Apr, 2020
Received 26 Apr, 2020
On 23 Apr, 2020
Invitations sent on 10 Apr, 2020
On 10 Apr, 2020
On 26 Mar, 2020
On 25 Mar, 2020
On 25 Mar, 2020
On 23 Mar, 2020
Posted 04 Nov, 2020
On 30 Oct, 2020
On 29 Oct, 2020
On 22 Oct, 2020
On 29 Sep, 2020
On 28 Sep, 2020
On 28 Sep, 2020
On 08 Sep, 2020
Received 01 Sep, 2020
Received 26 Aug, 2020
Received 21 Aug, 2020
On 13 Aug, 2020
On 13 Aug, 2020
Received 13 Aug, 2020
On 12 Aug, 2020
On 11 Aug, 2020
On 10 Aug, 2020
Invitations sent on 10 Aug, 2020
On 09 Aug, 2020
On 09 Aug, 2020
On 15 Jul, 2020
Received 13 Jul, 2020
On 23 Jun, 2020
On 22 Jun, 2020
Received 08 Jun, 2020
On 15 May, 2020
Received 26 Apr, 2020
Received 26 Apr, 2020
On 23 Apr, 2020
Invitations sent on 10 Apr, 2020
On 10 Apr, 2020
On 26 Mar, 2020
On 25 Mar, 2020
On 25 Mar, 2020
On 23 Mar, 2020
Background: Direct agglutination test (DAT) as a simple, accurate and reliable method, has been widely used for serodiagnosis of visceral leishmaniasis (VL) during the last three decades. The present study is a systematic review and meta-analysis to evaluate the diagnostic accuracy of DAT for serodiagnosis of human VL.
Methods: Electronic databases, including MEDLINE (via PubMed), SCOPUS, Web of Science, SID and Mag Iran (two Persian scientific search engines) were searched from December 2004 to April 2019. We determined the pooled sensitivity and specificity rates of DAT for the diagnosis of human VL, calculated positive and negative likelihood ratios (LR+ and LR-), and constructed summary receiver operating characteristic (ROC) curves parameters across the eligible studies.
Results: Of the 2928 records identified in the mentioned electronic databases and after examining reference lists of articles, 24 articles met inclusion criteria and were enrolled in the systematic review and out of them 20 records qualified for meta-analysis. The pooled sensitivity and specificity rates of DAT was 96% [95% CI, 92–98] and 98% [95 % CI, 86–99], respectively. The likelihood ratio of a positive test (LR+) was found to be 21 [CI95%, 6.6–66.5] and the likelihood ratio of a negative test (LR−) was found to be 0.04 [(CI95%, 0.02–0.08]. The combined estimate of the diagnostic odds ratio for DAT was high [467 (CI95%, 114-1912]). We found that the summary receiver operating characteristic curve (SROC) is positioned near the upper left corner of the curve and the area under curve (AUC) was 0.98 (95% CI, 0.97 to 0.99).
Conclusion: Referring to our analysis, we determined that DAT can be considered as a valuable tool for the serodiagnosis of human VL with high sensitivity and specificity. As DAT is a simple, accurate and efficient serological test, it can be recommended for serodiagnosis of human VL particularly in endemic areas.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5
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