Laboratory diagnostics for human Leishmania infections: a polymerase chain reaction-focussed review of detection and identification methods

Table 5 Commercially available DNA-based diagnostic kits for detection of Leishmania

Product	Supplier	Technology	Gene	Reported sensitivity	Species detected	Regulatory approval (agency)
EasyScreen Leishmania Detection Kit	Genetic Signatures	qPCR	18S rRNA	10 Copies/PCR	Pan-Leishmania	No
GenesigLeishmania (all species)	Primer Design	qPCR	cytb	100 Copies/PCR	Pan-Leishmania	No
Leishmania infantum and Leishmania donovani PCR Kit	MyBioSource	qPCR	DNA pol I protein B	100 Copies/PCR	L. infantum and L. donovani	No
Leishmania OligoC-TesT	Coris BioConcept	NASBA-OC	18S ribosomal	1 Parasite/PCR	Pan-Leishmania	No
Leishmania major PCR Kit	MyBioSource	qPCR	ND1	100 Copies/PCR	L. major	No
Leishmania sp. PCR Detection Kit	BioKits	cPCR	NR	20 Copies/mL	Pan-Leishmania	No
Leishmania tropica PCR Kit	MyBioSource	qPCR	GP63	100 Copies/PCR	L. tropica	No
Loopamp Leishmania Detection Kit	Eiken	LAMP	18S rRNA/kDNA minicircle	NR	Pan-Leishmania	No
SMART Leish^a	Cepheid/WRAIR	qPCR	16S rRNA/GPI gene	4 Copies/PCR	CL causative species	Yes (FDA)
STAT-NAT Leishmania spp.	Sentinel Diagnostics	qPCR	NR	NR	Pan-Leishmania	No

NR Not recorded, FDA Food and Drug Administration (USA), qPCR real-time PCR, NASBA-OC nucleic acid sequence-based amplification-oligochromatography, WRAIR Walter Reed Army Institute of Research, cPCR conventional PCR, kDNA kinetoplast DNA; for other abbreviations, see Table 1
^aThe SMART Leish Kit is intended for use only in US Department of Defense laboratories

ISSN: 1756-3305