Diagnosing visceral leishmaniasis with the recombinant K39 strip test: experience from the Sudan

Zijlstra, E.E.; Nur, Y.; Desjeux, Philippe; Khalil, E. A. G.; Elhassan, Ahmed M.; Groen, Jan

doi:10.1046/j.1365-3156.2001.00680.x

Cited by 153 publications

(120 citation statements)

References 17 publications

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“…Several samples of healthy endemic controls tested positive with the dipstick, but not with DAT. This is in line with observations of Zijlstra et al (2001) who also found healthy Sudanese controls without any history of VL positive with the rK39 dipstick (sensitivity of 96.8%). More importantly, the rK39 dipstick showed in several cases cross reactions with serum samples of patients with other infectious diseases, among which is Chagas disease (33% false positives) an infection which in the acute phase should always be included in the differential diagnosis of any unknown fever in the Brazilian situation.…”

Section: Resultssupporting

confidence: 92%

“…It failed to detect antibodies in three serum samples (one from Ethiopian origin and two from Brazilian origin) of parasitologically confirmed VL patients. This is in line with observations of Zijlstra et al (2001) who also found a lower sensitivity (67%) of the rK39 compared to DAT when testing serum samples from African VL patients in Sudan. In addition, Veeken (2001) has observed a low specificity (59-70%) of the rK39 test.…”

Section: Discussionsupporting

confidence: 92%

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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: Resultssupporting

confidence: 92%

Section: Discussionsupporting

confidence: 92%

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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“…In Sudan, Uganda, India and Afghanistan, validation studies of the rK39 rapid test yielded sensitivities that ranged from 67-100%. Despite the variability in the sensitivity, these studies reported similar specificities (95-100%) (Zijlstra et al 2001, Singh et al 2002, Chappuis et al 2005, Ritmeijer et al 2006) and this finding is in agreement with the results of the current study.…”

Section: Discussionsupporting

confidence: 93%

Specificity of the rapid rK39 antigen-based immunochromatographic test Kalazar Detect(r) in patients with cutaneous leishmaniasis in Brazil

Molinet

Ampuero

Costa

et al. 2013

Mem. Inst. Oswaldo Cruz

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“…The sensitivity of the rK39 RDT has been reported to vary between 37 and 100%, and the specifi city was estimated between 59 and 100% among immunocompetent patients in endemic regions [9][10][11][12][13][14][15][16] . In addition, a meta-analysis of 13 studies reported an overall sensitivity and specifi city of 93.9% and 90.6%, respectively 15 .…”

Section: Introductionmentioning

confidence: 99%

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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Diagnosing visceral leishmaniasis with the recombinant K39 strip test: experience from the Sudan

Cited by 153 publications

References 17 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

Specificity of the rapid rK39 antigen-based immunochromatographic test Kalazar Detect(r) in patients with cutaneous leishmaniasis in Brazil

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

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