Medica 2026
Nov 16-19, 2026 - Düsseldorf, Germany

Anti-Leishmania IgG ELISA Kit for Human Serology

Leishmaniasis, a neglected tropical disease caused by protozoan parasites of the genus Leishmania, poses a significant global health burden, affecting millions of people across more than 90 countries. Transmitted through the bites of infected female phlebotomine sandflies, the disease manifests in several clinical forms, including cutaneous, mucocutaneous, and visceral leishmaniasis. Among these, visceral leishmaniasis, also known as kala-azar, is the most severe form, often fatal if left untreated. Early and accurate diagnosis is crucial for effective treatment and control of the disease spread. Serological tests play a vital role in the diagnosis of leishmaniasis, particularly in regions where the disease is endemic. The detection of specific antibodies against Leishmania parasites in human serum provides valuable information for confirming infection. The Anti-Leishmania IgG ELISA Kit for Human Serology is a sophisticated diagnostic tool designed to detect immunoglobulin G (IgG) antibodies against Leishmania species in human serum samples, offering high sensitivity and specificity for reliable results.

Leishmania.Figure 1. Leishmania.

Intended Use and Principle of the Assay

The Anti-Leishmania IgG ELISA Kit is an in vitro diagnostic enzyme immunoassay for the qualitative and/or quantitative detection of IgG class antibodies against Leishmania spp. in human serum or plasma. It is intended for use as an aid in the diagnosis of active visceral leishmaniasis and can also be a valuable tool in seroprevalence studies.

Technology Platform

Technology Platform

  • Bridging ELISA
  • Indirect ELISA
  • Competitive ELISA
  • Homogeneous ELISA

Sample Type Compatibility

  • Human Serum
  • Human Plasma
  • Other Biological Fluids
  • Clinical Trial Samples

Sensitivity Profile

  • High Sensitivity
  • Ultra-High Sensitivity
  • Regulatory-Compliant
  • Matrix Interference-Optimized

Kit Features

  • Pre-Coated Microplate
  • Complete Reagent Set
  • Automation-Compatible
  • Wide Dynamic Range
  • Stable Storage (2-8℃, long shelf-life)
  • Rapid Assay Protocol

Key Components & Specifications

Performance Characteristics

  • Analytical Sensitivity: The lowest antibody concentration that can be consistently distinguished from the negative control is typically very low, often in the low ng/mL range.
  • Analytical Specificity: Cross-reactivity testing shows minimal interference with sera from patients with other parasitic diseases (e.g., Chagas disease, malaria), autoimmune diseases (e.g., rheumatoid factor), or viral infections (e.g., HIV, Hepatitis).
  • Precision: Both intra-assay precision (repeatability) and inter-assay precision (reproducibility) demonstrate low coefficients of variation (CV %), usually <10% for OD values.

Sample Collection and Preparation

  • Sample Type: Human serum or plasma (EDTA, heparin, or citrate).
  • Collection: Collect blood using aseptic techniques. Allow blood to clot completely for serum separation (30 mins at 37°C or longer at 2-8°C). Centrifuge at room temperature for 15 minutes at 1000 × g to separate serum/plasma.
  • Handling: Clearly label all samples. Test samples should be clear and non-hemolyzed. Grossly lipemic, hemolyzed, or contaminated samples should be avoided.
  • Storage: Samples can be stored at 2–8°C for short-term (up to 48 hours). For longer storage, aliquot and freeze at -20°C or lower. Avoid repeated freeze-thaw cycles.

Applications in Clinical and Research Settings

  • Clinical Diagnosis: Highly sensitive screening for suspected visceral leishmaniasis, especially when parasitological diagnosis is negative, impractical, or risky (e.g., splenic puncture).
  • Epidemiological Studies: Enables serosurveys to determine Leishmania infection prevalence, geographic distribution, and identify asymptomatic carriers.
  • Treatment Monitoring: Serial quantitative antibody measurements help assess chemotherapy efficacy; successful treatment correlates with gradual decline in antibody titers.

Storage and Handling

  • Proper storage and handling of the Anti-Leishmania IgG ELISA Kit are essential to maintain the integrity and performance of the components.
  • Storage Temperature: The kit should be stored at 2-8°C upon receipt, unless otherwise specified in the instructions.
  • Avoid Freezing: Do not freeze the pre-coated microtiter plates, as this can damage the coated antigens.
  • Shelf Life: The kit is guaranteed to perform within specifications until the expiration date printed on the box, provided it is stored and handled correctly.
  • Handling Reagents: When handling the reagents, use clean, sterile pipettes and containers to avoid contamination. Do not mix reagents from different kit lots.

Data Analysis and Interpretation

Determination of Data Analysis.

Calculation

  1. Calculate the mean OD value for the Negative Control.
  2. Calculate the mean OD value for the Positive Control.
  3. The test is valid only if the mean Negative Control OD is below a specified value (e.g., < 0.250) and the mean Positive Control OD is above a specified value (e.g., > 1.000), as stated in the IFU.
Determination of Data Analysis.

Determination

  • Negative: Sample OD < Cut-Off Value. Indicates the absence of detectable levels of anti-Leishmania IgG antibodies.
  • Positive: Sample OD ≥ Cut-Off Value. Indicates the presence of anti-Leishmania IgG antibodies, suggestive of current or past infection.
  • Equivocal/Borderline: Samples with an OD value very close to the cut-off may be considered equivocal and should be retested.

Anti-Leishmania IgG ELISA Kit for Human Serologys

ParameterDetails
Product nameLeishmania Antibody ELISA Kit
SampleSerum, plasma
Intended UseThis kit is intended for the qualitative determination of IgG class antibodies against Leishmania infantum in human serum or plasma (citrate, heparin).
Species ReactivityStore the kit at 2-8 °C. The opened reagents are stable up to the expiry date stated on the label when stored at 2-8 °C.
StorageLeishmania are protozoa belonging to the family trypanosomatidae. The parasites exist in two forms: the promastigotes in the midgut of the vector insect, and the amastigotes within the phagolysosomes of macrophages in their mammalian hosts. In the macrophages they live as round, non-motile amastigotes (3-7 μm in diameter). The macrophages are ingested by the sandfly during blood-meal and the amastigotes are released into their stomach. Almost immediately the amastigotes transform in to the motile, elongated (10-20μm), flagellate promastigote form, which migrate to the alimentary tract of the fly and after multiplication move forward to the salivary glands of the insect. Leishmaniases are a globally widespread group of parasitic diseases; the "type" is determined by the primary location of the macrophages that are infected. In humans four different forms of Leishmaniasis with a broad range of clinical manifestations are present; all can have devasting consequences. Leishmaniasis currently affects some 12 million people in 88 countries, all but 16 of which are in the developing world.

Result Interpretation

The results of the Anti-Leishmania IgG ELISA Kit are interpreted based on the absorbance values obtained from the microplate reader.

Calculate the mean absorbance value for each duplicate sample, positive control, and negative control.

Determine the cut-off value, which is typically calculated as the mean absorbance of the negative control plus a certain factor (e.g., 0.100 or 2-3 standard deviations above the negative control mean). The specific cut-off value is provided in the kit instructions.

Data Analysis and Interpretation

Classify the samples:

Quality Control: The positive control should have an absorbance value above the cut-off, and the negative control should have an absorbance value below the cut-off. If the controls do not meet these criteria, the assay may be invalid, and the test should be repeated.

Advantages of Anti-Leishmania IgG ELISA Kit for Human Serology

Fast turnaround time

Most test kits can detect results within 2-3 hours, which is faster than virus culture and on par with RIDT. This allows clinicians to make clinical decisions in a timely manner.

Specificity

Specificity is the ability of the kit to correctly identify individuals without leishmaniasis. It is evaluated using serum samples from healthy individuals and those with other infectious diseases to avoid cross-reactivity.

Precision

Precision includes intra-assay and inter-assay precision. Intra-assay precision is determined by testing the same sample multiple times within a single assay, while inter-assay precision is evaluated by testing the same sample in multiple assays on different days.

Conclusions

The Anti-Leishmania IgG ELISA Kit is a cornerstone in the modern diagnostic arsenal against leishmaniasis. Its high degree of accuracy, standardization, and suitability for high-throughput testing make it an indispensable tool for clinical laboratories, reference centers, and public health programs worldwide. By enabling the reliable detection of specific antibodies, this kit facilitates earlier diagnosis and intervention for visceral leishmaniasis, ultimately contributing to reduced mortality and improved patient outcomes. It also provides critical data for understanding the epidemiology of this complex disease, paving the way for more effective control and elimination strategies.

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