Value of a dipstick based on recombinant rK39 antigen for differential diagnosis of American visceral leishmaniasis from other sympatric endemic diseases in Venezuela

Delgado, Olinda; Feliciangeli, M. Dora; Coraspe, Virginia; Silva, S.; Pérez, Alícia; Árias, Jorge R.

doi:10.1051/parasite/2001084355

Cited by 27 publications

(21 citation statements)

References 10 publications

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“…rK39 dipstick tests have been shown to be quite sensitive (reported sensitivities, 67 to 100%) and very specific (reported specificities, 97 to 100%) when tested on kala-azar patients (5,8,13,25,30), with results similar to those of rK39-ELISAs (1,4,7,12,14,17,18,24,28,29). Although rK39-ELISAs have been used to detect ZVL infection in dogs (4,17,22,23,28), there are no published reports on the use of the rK39 dipstick to detect ZVL in dogs.…”

supporting

confidence: 56%

“…Previous studies using the rK39-ELISA assay reported responsiveness to rK39 in (i) 2 of 33 Chinese toxoplasmosis patients (although the authors reported that the two responsive patients may have had subclinical ZVL) (24), (ii) 2 of 61 healthy Sudanese controls from a region of endemicity (29), (iii) 1 of 10 Turkish malaria patients (17), and (iv) 6 of 83 Turkish cutaneous leishmaniasis patients (17). The rK39 antigen is not known to crossreact with Leishmania braziliensis or T. cruzi (4,7,8,18). Also, rK39 responsiveness appears to be restricted to active kalaazar infections, as opposed to asymptomatic, self-healing, cured, or treatment-resistant patients (4,14,24) or dogs (22,23), although other studies failed to show such an association (29,30).…”

Section: Discussionmentioning

confidence: 91%

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Rapid Detection of Leishmania infantum Infection in Dogs: Comparative Study Using an Immunochromatographic Dipstick Test, Enzyme-Linked Immunosorbent Assay, and PCR

et al. 2002

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Current zoonotic visceral leishmaniasis (ZVL) control programs in Brazil include the culling of Leishmania infantum-infected reservoir dogs, a strategy that has failed to prevent a rise of canine and human ZVL cases over the past decade. One of the main reasons this strategy has failed is because of a long delay between sample collection, sample analysis, and control implementation. A rapid, sensitive, and specific diagnostic tool would be highly desirable, because it would allow control interventions to be implemented in situ. We compared an immunochromatographic dipstick test to enzyme-linked immunosorbent assay (ELISA) and PCR for detecting L. infantum infections in dogs from an area of ZVL endemicity in Brazil. The dipstick test was shown to have 61 to 75% specificity and 72 to 77% sensitivity, compared to 100% specificity for both ELISA and PCR and 71 to 88% and 51 to 64% sensitivity for ELISA and PCR, respectively. Of the field samples tested, 92 of 175 (53%), 65 of 175 (37%), and 47 of 175 (27%) were positive by dipstick, ELISA, and PCR, respectively. The positive and negative predictive values for the tested dipstick were 58 to 77% and 75%, respectively. Efforts should be made to develop a more specific dipstick test for diagnosis of leishmaniasis, because they may ultimately prove more cost-effective than currently used diagnostic tests when used in mass-screening surveys.Domestic dogs (Canis familiaris) are established reservoir hosts of zoonotic visceral leishmaniasis (ZVL) caused by Leishmania infantum. Hence, one of the approaches to reduce the incidence of human ZVL (also known as kala-azar) is to cull infected dogs. The impact of such dog-culling programs on incidence of human and canine ZVL has been doubted on both theoretical and practical grounds (10), and the results of controlled intervention trials are equivocal (3, 9). Despite the culling of an average of 19,500 dogs per year since 1989, the incidence of human ZVL in Brazil has increased steadily during the same period (26). One of the reasons why such control campaigns have failed is because of the long delay between sample collection, sample analysis, and control implementation (i.e., culling of infected dogs). This delay typically is 30 days long, but can be as long as 80 days, with infected dogs remaining infectious to sandfly vectors during this period and transmitting ZVL to susceptible dogs and humans. In a study in Brazil, it was shown that whereas a standard culling strategy implemented 80 days postsample collection resulted in only a 9% decrease in dog seroprevalence, culling implemented 7 days postsample collection resulted in a 27% decrease in seroprevalence (6). Current diagnostic methods used for Leishmania mass-screening surveys (mainly enzyme-linked immunosorbent assay [ELISA], immunofluorescence antibody test, or direct agglutination test) lack sensitivity or specificity, require technological expertise and specialized laboratory equipment, and can be labor-intensive and time-consuming. Hence, a rapid, sensitive and specifi...

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supporting

confidence: 56%

Section: Discussionmentioning

confidence: 91%

Rapid Detection of Leishmania infantum Infection in Dogs: Comparative Study Using an Immunochromatographic Dipstick Test, Enzyme-Linked Immunosorbent Assay, and PCR

et al. 2002

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“…Our study indicates lower specificities (85 to 98%) as assessed with sera from healthy blood donor dogs and cross-reactive sera obtained from dogs infected with either L. braziliensis or Leptospira interrogans (Table 2). Interestingly, previous reports have suggested that the rK39 and rK26 antigens when used for the diagnosis of human VL do not crossreact with L. braziliensis (3,9,13). In addition, in previous studies with human VL (10), we found that the antigen rA2 is recognized by 60% of sera from patients with mucosal leishmaniasis, which is caused by L. braziliensis.…”

Section: Discussionmentioning

confidence: 84%

Comparative Evaluation of Enzyme-Linked Immunosorbent Assays Based on Crude and Recombinant Leishmanial Antigens for Serodiagnosis of Symptomatic and Asymptomatic Leishmania infantum Visceral Infections in Dogs

Porrozzi

Costa

Têva

et al. 2007

Clin Vaccine Immunol

128

123

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The diagnosis of visceral leishmaniasis remains difficult in rural areas where the disease is endemic, and serologic methods still need assessment, as they are not very sensitive for the detection of asymptomatic infectious dogs. Here we present data on the development of enzyme-linked immunosorbent assay (ELISA)-based methods for the detection of antibodies against recombinant leishmanial antigens (namely, the recombinant K26 [rK26] and rK39 antigens from Leishmania infantum and the rA2 protein from Leishmania donovani) in comparison to ELISAs employing crude soluble antigen (CSA). The assays utilized sera from known negative controls (n ‫؍‬ 25) and clinically asymptomatic (n ‫؍‬ 50) and symptomatic (n ‫؍‬ 50) dogs with confirmed L. infantum infections. Additional studies were also done using sera from animals harboring other infections (n ‫؍‬ 14) for the evaluation of cross-reactivity. Our study indicated that rK26 and rK39 used in ELISAs provided very high sensitivities for the detection of symptomatic dogs (94% and 100%, respectively), followed by CSA (88%) and rA2 (70%). Conversely, rA2 was more sensitive for asymptomatic dogs (88%) than rK39 and rK26 (both 66%) and CSA (30%). Some cross-reactivity in sera from dogs with other infections (Leishmania braziliensis and Leptospira interrogans) was identified, but the rA2 protein provided the greatest specificity (98%). Data further indicate that all three recombinant proteins must be used in parallel to detect essentially all infected dogs. Efforts should be made to develop a cheap and reliable serologic test based on epitope selection from these diagnostic markers for the sensitive detection of L. infantum-infected dogs.

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“…The Kalazar Detect test showed a similarly high level of sensitivity (range, 98 to 100%), as it has in other regions of endemicity (4,6). Other anti-K39 strip tests also have been or are now being evaluated (13,16,19,20), and most (but not all) (20) reports have shown high sensitivity (range, ϳ90 to 100%).…”

mentioning

confidence: 89%

Rapid, Noninvasive Diagnosis of Visceral Leishmaniasis in India: Comparison of Two Immunochromatographic Strip Tests for Detection of Anti-K39 Antibody

et al. 2006

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Used with blood or serum, a new anti-K39 antibody immunochromatographic strip test (IT-Leish; DiaMed AG) proved sensitive (range, 99 to 100%) and specific (range, 95 to 100%) for the noninvasive serodiagnosis of visceral leishmaniasis in India. Used with serum, the IT-Leish test and the existing Kalazar Detect test (InBios International, Inc.) yielded comparable results for symptomatic infection and identified apparent subclinical infection in 15 to 32% of healthy residents in a region where visceral leishmaniasis is highly endemic.

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Value of a dipstick based on recombinant rK39 antigen for differential diagnosis of American visceral leishmaniasis from other sympatric endemic diseases in Venezuela

Cited by 27 publications

References 10 publications

Rapid Detection of Leishmania infantum Infection in Dogs: Comparative Study Using an Immunochromatographic Dipstick Test, Enzyme-Linked Immunosorbent Assay, and PCR

Rapid Detection of Leishmania infantum Infection in Dogs: Comparative Study Using an Immunochromatographic Dipstick Test, Enzyme-Linked Immunosorbent Assay, and PCR

Comparative Evaluation of Enzyme-Linked Immunosorbent Assays Based on Crude and Recombinant Leishmanial Antigens for Serodiagnosis of Symptomatic and Asymptomatic Leishmania infantum Visceral Infections in Dogs

Rapid, Noninvasive Diagnosis of Visceral Leishmaniasis in India: Comparison of Two Immunochromatographic Strip Tests for Detection of Anti-K39 Antibody

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