Rapid Immunochromatographic Diagnostic Test (DiaMed-IT LEISH)

for Visceral Leishmaniasis

K39 in the Diagnosis of KALA-AZAR

39 Amino Acid antigen encoded by 117 bp gene in kinesine region of amastigotes

K39 ELISA – high Sensitive & Specific, not practical for use in the field.
Rapid test developed using immunochromatographic strips.
K39 is fixed on the strip, and anti-K39 antibodies conjugated with colloidal gold are used for
the detection
Preliminary Analysis Opti-Leish® (DiaMed) Test

Pooled Data Sudan (Lankien, Latjor, Um-el-Kher), April 2004

Diagnosis by MSF Protocol in clinically suspect cases

Diagnosis Positive Negative
Dipstick DAT-pos or Asp-pos DAT-neg or Total
DAT-bl and Asp-neg
Positive 184 3 187
Negative 44 111 155
Total 228 114 342

Sensitivity 80.7% 95% CI: 75.0 – 85.6%

Specificity 97.4% 95% CI: 92.5 – 99.5%
PPV 98.4% 95% CI: 95.4 – 99.7%
NPV 71.6% 95% CI: 63.8 – 78.6%

Parasitologically Confirmed KA cases

Dipstick Aspirate positive
Positive 179
Negative 21
Total 200

Sensitivity: 89.5% 95% CI: 84.4 – 93.4%

Endemic Controls: non-KA cases

Dipstick DAT negative
Positive 0
Negative 131
Total 131

Specificity: 100.0% 95% CI: 97.2 – 100.0%

Proposed New Diagnostic Algorithm:

1. Clinical screening and exclusion of malaria,

2. Opti-Leish test in clinically suspect primary kala-azar  treat if positive,

3. DAT on those with negative Opti-Leish test  treat if positive,
4. Aspirate on those with borderline DAT  treat if positive.
5. Cinically suspect relapse kala-azar will be diagnosed by aspiration.