Use of the recombinant K39 dipstick test and the direct agglutination test in a setting endemic for visceral leishmaniasis in Nepal.

Bern, Caryn; Jha, Shambhu Nath; Joshi, Ashok; Thakur, Gargi; Bista, Mahendra Bahadur

doi:10.4269/ajtmh.2000.63.153

Cited by 94 publications

(73 citation statements)

References 19 publications

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“…In contrast, Sundar et al (1998) reported a 100% sensitivity for the test using peripheral blood samples from Indian patients. This observation was confirmed by Bern et al (2000) in a study in Nepal. These observations suggest a regional limitation of the use of the rK39 test.…”

Section: Discussionsupporting

confidence: 69%

Evaluation of the direct agglutination test and the rK39 dipstick test for the sero-diagnosis of visceral leishmaniasis

Schallig¹,

Canto-Cavalheiro²,

Silva

2002

Mem. Inst. Oswaldo Cruz

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The direct agglutination test (DAT) based on a freeze-dried antigen and the rK39 dipstick test were evaluated for the sero-diagnosis of visceral leishmaniasis (VL). The sensitivity and specificity of both tests were determined using sera from confirmed VL patients (n = 21), healthy controls (n = 19) and from patients with other confirmed infectious diseases (n = 42). The DAT had a sensitivity and a specificity of 100%. The rK39 had a sensitivity of 85.7% and a specificity of 82%. Both tests were also used to screen blood samples of confirmed VL patients (n = 15) Visceral leishmaniasis (VL or kala-azar) is the most severe form of leishmaniasis. Approximately 500,000 new cases of human VL occur annually and the disease is mainly found in Brazil, East Africa and on the Indian subcontinent. American visceral leishmaniasis (AVL), caused by Leishmania chagasi, is a major health problem in many parts of Brazil. Traditionally, the disease was confined to rural and peri-urban areas, but in the last few years the number of human cases of AVL in metropolitan regions is dramatically increasing (Silva et al. 2001). It is important to diagnose AVL as early as possible, because the disease is in most cases fatal if left untreated. The principal clinical symptoms of AVL are an enlarged spleen and a prolonged irregular fever (WHO 1996). Other signs and symptoms are loss of weight, pallor, enlarged liver, enlarged lymph nodes, anaemia, cough and diarrhoea. These signs and symptoms may mimic those of malaria, typhoid, tuberculosis, schistosomiasis and other diseases. The clinical suspicion may be confirmed directly by the detection of parasites in patient material or by culture. However, sample retrieval is inconvenient for the patient and parasite isolation by culture is time-consuming, expensive and difficult.Because of the above-mentioned limitations of direct diagnostic methods, a number of indirect immunological tests have been developed. These tests should meet several prerequisites in order to be of practical use. They should be sensitive and specific, cheap (in particular for use in developing countries) and easy to perform under harsh field conditions (Veeken 1999). The direct agglutination test (DAT) remains the first line diagnostic tool in many developing countries as it is a simple test with a high sensitivity, specificity and reproducibility, easyto-perform and not requiring specialised equipment (Zijlstra et al. 1991, Boelaert et al. 1999a,b, Schallig et al. 2001. The introduction of a freeze-dried antigen makes the DAT very suitable for use under remote field conditions as a cold chain for storage of antigen is not required (Meredith et al. 1995, Zijlstra et al. 1997, Schallig et al. 2001. A limitation of the DAT is the relatively long incubation time (18 h) and the fact that serial dilutions of blood or serum must be made. A dipstick, rK39 dipstick, based on the cloned antigen of a 39 amino acid repeat that is part of a 230 kDa protein encoded by a kinesin-like gene of L. chagasi (Burns et al. 1993), may circu...

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Section: Discussionsupporting

confidence: 69%

Evaluation of the direct agglutination test and the rK39 dipstick test for the sero-diagnosis of visceral leishmaniasis

Schallig¹,

Canto-Cavalheiro²,

Silva

2002

Mem. Inst. Oswaldo Cruz

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“…A similar fi nding was observed in a study comparing an RDT with the direct agglutination test (DAT) 30 . Nonetheless, a Brazilian study showed that IT-LEISH TM , but not Kalazar Detect TM , performed signifi cantly better than IFI with greater specifi city and PPV 21 .…”

Section: Ethical Considerationssupporting

confidence: 78%

Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting

Moura

Lopes

Mourão

et al. 2013

Rev. Soc. Bras. Med. Trop.

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Introduction: Rapid diagnostic tests (RDTs) may improve the early detection of visceral leishmaniasis (VL), but their real-world performance requires additional study. Therefore, we evaluated the performance of an rK39-based RDT (Kalazar Detect TM ) for the detection of VL in an endemic, large urban area. Methods: Data were collected from a registry of rK39 RDT performed at 11 emergency care units in Belo Horizonte, Brazil, and from a national database of reportable communicable diseases of the Sistema de Informação de Agravos de Notifi cação (SINAN). Results: The rapid rK39 test was performed in 476 patients, with 114 (23.9%) positive results. The analysis of rK39 RDT performance was based on 381 (80%) cases reported to the SINAN database, of which 145 (38.1%) were confi rmed cases. Estimates for sensitivity and specifi city were 72.4% (95% CI: 64.6-79%) and 99.6% (95%CI: 97.6-99.9%), respectively. Positive and negative predictive values were estimated at 99.1% (95%CI: 94.9-99.8%) and 85.5% (95%CI: 80.8-89.1%), respectively. In addition, close agreement between the rK39 RDT and indirect immunofl uorescence was observed. Conclusions: In summary, the rK39 RDT showed a high specifi city but only moderate sensitivity. In endemic areas for VL, treatment may be considered in cases with clinical manifestations and a positive rK39 RDT, but those with a negative test should be subjected to further investigation.

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“…A mais alta sensibilidade (100%) ocorreu em pacientes da India and Nepal. [9][10][11] Pacientes da Venezuela tiveram menor porcentagem de resultados verdadeiros positivos (88%), e o teste com o rk39 foi menos sensíveis em pacientes do Sudão e outras áreas. 12-14 A Tabela 2 resume os dados da literatura usando soro ou sangue total como amostra para o teste rápido.…”

Section: Discussionunclassified

“…Como controle foram incluídos soros de 10 indivíduos saudáveis e de 50 pacientes portadores de outras infecções como: malária (10), hanseníase (9), doença de Chagas (10), tuberculose (10) e leishmaniose cutânea (11). A sensibilidade do teste rápido com antígeno rK39 e ELISA foram 90% e 89% respectivamente, enquanto a especificidade foi 100% e 98% respectivamente.…”

Section: Introductionunclassified

Avaliação do teste rápido utilizando o antígeno recombinante K39 no diagnóstico da leishmaniose visceral no Brasil

Lemos

Carvalho

Corey

et al. 2003

Rev. Soc. Bras. Med. Trop.

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Este estudo avaliou o desempenho teste rápido de imunocromatografia utilizando o antígeno rK39 (Kalazar Detected® InBios International, Seattle, WA, USA) e um teste de ELISA utilizando antígeno total, para o diagnóstico da leishmaniose visceral (LV) em 128 pacientes com diagnóstico parasitológico da doença. Como controle foram incluídos soros de 10 indivíduos saudáveis e de 50 pacientes portadores de outras infecções como: malária (10), hanseníase (9), doença de Chagas (10), tuberculose (10) e leishmaniose cutânea (11). A sensibilidade do teste rápido com antígeno rK39 e ELISA foram 90% e 89% respectivamente, enquanto a especificidade foi 100% e 98% respectivamente. Nossos dados portanto, confirmam a eficiência do teste rápido com rK39 no diagnóstico da LV

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Use of the recombinant K39 dipstick test and the direct agglutination test in a setting endemic for visceral leishmaniasis in Nepal.

Cited by 94 publications

References 19 publications

Evaluation of the direct agglutination test and the rK39 dipstick test for the sero-diagnosis of visceral leishmaniasis

Evaluation of the direct agglutination test and the rK39 dipstick test for the sero-diagnosis of visceral leishmaniasis

Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting

Avaliação do teste rápido utilizando o antígeno recombinante K39 no diagnóstico da leishmaniose visceral no Brasil

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