Lepto IgG/IgM Rapid Test Kit
Lepto IgG/IgM Rapid Test Kit is a professional veterinary rapid test for qualitative or semi-quantitative screening of Leptospira IgG/IgM antibodies in Canine/feline serum or plasma; whole-blood workflow per final IFU. The product is designed for clear line interpretation, standardized sample preparation and traceable lot management across companion-animal clinics and distributor portfolios.
Product Features
Fast 5-10 minute turnaround
Most assays can be interpreted within the 5-10 minute window to support rapid clinical triage.
Matched buffer and workflow
Device, buffer and sampling tools form a standardized operating set that reduces workflow variation.
Clear C/T or C/R/T line design
The control line confirms valid migration and reagent function for intuitive interpretation.
Distributor and OEM ready
Controlled IFU, label files, lot documents and performance data can support registration discussions.
Technical Specifications
- Target
- Leptospira IgG/IgM antibodies
- Specimen
- Canine/feline serum or plasma; whole-blood workflow per final IFU
- Method
- Colloidal gold immunochromatography (lateral flow)
- Read time
- Read at 10 min; do not interpret after 15 min
- Pack size
- 10 Tests/Kit
- Storage
- 2-30°C, dry and protected from light; do not freeze
- Format
- Single-use rapid test cassette, visual readout
- Sample and buffer
- 10 µL specimen into buffer tube; add 3-4 drops of mixed buffer
- Result type
- Qualitative IgG/IgM antibody screening: positive / negative / invalid
- Kit components
- Test cassette, assay buffer, dropper/pipette or swab accessories, package insert
Standard Workflow
Equilibrate
Bring kit and specimen to the appropriate operating temperature; check pouch integrity and expiry.
Prepare specimen
Process the recommended sample volume with the supplied buffer according to the final controlled IFU.
Apply sample
Dispense the prepared sample to the cassette well, keep the device level and start timing.
Read on time
Interpret only within the IFU-defined reading window; do not use results outside that window.
Result Interpretation
Positive / Abnormal
The control line appears and the test or reference-line combination meets the IFU criteria, indicating detectable antibody, antigen or biomarker level.
Negative / Normal
A valid control line appears and the test line does not meet the IFU criteria. Negative results do not exclude low level, early window, intermittent shedding or sampling variation.
Invalid
No valid control line appears or the line pattern does not meet IFU requirements. Repeat with a new device and specimen.
Clinical Interpretation
Supports first-line assessment of leptospira exposure or suspected infection and should be interpreted with vaccination history, exposure risk, clinical signs and other laboratory methods.
Quality & Technical Documentation
Parameters are organized from the product artwork, available IFU materials and Safheal technical positioning. Final commercial claims, limit of detection, cross-reactivity, interference and clinical agreement follow controlled IFU, registration label, performance report and lot-release records.