Evidence map›Paper›PMID 30439953›Full record

ArticlePLoS neglected tropical diseases2018

Validation of SYBR green I based closed tube loop mediated isothermal amplification (LAMP) assay and simplified direct-blood-lysis (DBL)-LAMP assay for diagnosis of visceral leishmaniasis (VL).

Keerti Kaumudee Dixit, Sandeep Verma, Om Prakash Singh, Dharmendra Singh, Akhil Pratap Singh, Ratan Gupta, Narendra Singh Negi, Pradeep Das, Shyam Sundar, Ruchi Singh and 1 more

Abstract readValidation Study
In one paragraph

Article in PLoS neglected tropical diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

11 authors.

Keerti Kaumudee DixitICMR-National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, India.
Sandeep VermaICMR-National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, India.
Om Prakash SinghDepartment of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
Dharmendra SinghRajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India.
Akhil Pratap SinghDepartment of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
Ratan GuptaDepartment of Paediatrics, Safdarjung Hospital and Vardhman Mahavir Medical college, New Delhi, India.
Narendra Singh NegiDepartment of Medicine, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, India.
Pradeep DasRajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India.
Shyam SundarDepartment of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
Ruchi SinghICMR-National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, India.
Poonam SalotraICMR-National Institute of Pathology, Safdarjung Hospital Campus, New Delhi, India.ORCID 0000-0002-4057-4872

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe World Health Organization has targeted elimination of visceral leishmaniasis (VL) in the Indian subcontinent (ISC) by 2020. Despite distinctive decline seen in the number of VL cases in ISC, there is still a quest for development of a diagnostic test which has the utility for detection of active infection and relapse cases and as a test of cure. The present study validated the sensitivity and specificity of SYBR Green I based closed tube LAMP assay reported by us for diagnosis of VL. METHODOLOGY: The validation study was carried out at two endemic sites in India, located at Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna and Institute of Medical Sciences (IMS), Banaras Hindu University (BHU), Varanasi. Standard operating protocols were provided at the two sites for applying LAMP assay on confirmed VL cases. The diagnostic accuracy of LAMP assay was evaluated by Receiver operator curve (ROC) analysis. Furthermore, a simplified LAMP assay based on direct blood lysis, DBL-LAMP, was developed and verified for its diagnostic accuracy. PRINCIPAL

findingsA total of 267 eligible participants were included in the study which comprised of 179 VL cases and 88 controls. Sensitivity and specificity of the LAMP assay were 98.32% (95% C.I- 95.2-99.7%) and 96.59% (95% C.I.-90.4-99.3%), respectively. ROC curve analysis depicted no significant difference between area under curve (AUCROC) for LAMP assay and rK39 RDT, indicative of LAMP as an excellent diagnostic test. DBL-LAMP assay, performed on 67 VL and 100 control samples, yielded a sensitivity of 93.05% (95% C.I- 84.75-97%) and specificity of 100% (95% C.I.- 96.30-100%). CONCLUSIONS/SIGNIFICANCE: The validated closed tube LAMP for diagnosis of VL will provide impetus to the ongoing VL elimination programme in ISC. The assay based on direct blood lysis promotes its scope for application in field settings by further reducing time and cost.

Indexed as

AdolescentAdultAgedBenzothiazolesBloodChildDiaminesFemaleHumansIndiaLeishmania donovaniLeishmaniasis, VisceralMaleMiddle AgedMolecular Diagnostic TechniquesNucleic Acid Amplification TechniquesBenzothiazolesDiaminesOrganic ChemicalsQuinolinesSYBR Green I

Identifiers

PMID30439953
PMCPMC6264900

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.