Table 2.
Characteristics of Visceral Leishmania Rapid Diagnostic Tests Included in the Evaluation
| Product | Manufacturer | Catalog No. | Lateral Flow Format | Lot No. | Storage Temperature | Shelf Life | Control Line | Test Line, Bound Antigen | Sample Volume (µL) | Buffer Quantity (Drops) | Minimum Reading Time (min) | Maximum Reading Time |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CrystalKA | Span Diagnostics, Ltd | 56FT101 | Dipstick | R2009004 | 4°C–30°C | 18 mo | Yes | rKE16 | 20 | 5 | 15 | 30 |
| R2009003 | ||||||||||||
| DiaMed-IT LEISH | Bio-Rad Laboratories | 710124 | Cassette | 46240.27.01 | 2°C–30°C | 16 mo | Yes | rK39 | 8–12 (10 μL mark on pipette) | Step 1: 1 (conjugate well), Step 2: 4 (wash well) | 5 | Not specified |
| 46240.28.01 | ||||||||||||
| Kalazar Detect | InBios International, Inc | INS105 | Dipstick | KE 2108 | RT (20°C–28°C) | 24 mo | Yes | rK39 | 20 | 3 | 10 | 10 |
| KE 1047 | ||||||||||||
| Signal–KA | Span Diagnostics Ltd | 56FT100 | Cassette | 4000002561 | 2°C–8°C | 12 mo | Yes | rKE16 | Mix 1 (20 μL) part serum with 4 parts normal saline, then use 50 μL. | Step 1: 2 Step 2: 2 Step 3: 3 | 2 | 10 |
| 4000002604 | ||||||||||||
| OnSite Leishmania Ab Rapid Test | CTK Biotech Inc | RO122S | Dipstick | F0317G2 | 2°C–30°C | 18 mo | Yes | rK39 | 5 | 2 | 15 | 15 |
| F0318G2 |