GHM TOXO IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Toxoplasma gondii IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM TOXO IgG/IgM Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM TOXO IgG/IgM Rapid Test US is a lateral flow chromatographic immunoassay designed for the simultaneous detection and differentiation of IgG and IgM antibodies to Toxoplasma gondii (T. gondii) in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of Toxoplasma gondii infection.

Toxoplasmosis is a zoonotic parasitic infection caused by the protozoan Toxoplasma gondii, one of the most successful parasites on earth. It is estimated that approximately one-third of the global human population has been exposed to this parasite, with the highest seroprevalence rates observed in Africa (46%) and South America (52.8%), and the lowest in Asia (29%) and North America (19.7%). The global seroprevalence of T. gondii in pregnant women is reported at 36.6% (95% CI: 33.7–39.6), underscoring the importance of routine screening in this vulnerable population.

While most immunocompetent individuals experience mild or asymptomatic infection, toxoplasmosis can cause severe complications in certain populations. In pregnant women, primary infection acquired during gestation can lead to vertical transmission to the fetus, resulting in congenital toxoplasmosis with potentially devastating consequences including miscarriage, stillbirth, hydrocephalus, intracranial calcifications, and chorioretinitis. In immunocompromised patients, reactivation of latent infection can cause life-threatening encephalitis. Accurate serological testing is critical for identifying infection status, determining whether exposure has occurred, and guiding clinical management.

The GHM TOXO IgG/IgM Rapid Test US delivers qualitative results in 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including obstetric clinics, prenatal screening programs, infectious disease clinics, and clinical laboratories.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including obstetric clinics, prenatal screening programs, infectious disease clinics, hospital laboratories, and clinical laboratories. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.

Key Features & Benefits

2-in-1 Detection – IgG and IgM in One Test

The GHM TOXO IgG/IgM Rapid Test US utilizes a lateral flow chromatographic immunoassay capable of simultaneously detecting and differentiating Toxoplasma gondii IgG and IgM antibodies from a single patient sample. The test incorporates two separate test lines: T1 for IgG and T2 for IgM, enabling clear differentiation between past exposure/immunity and recent/active infection in a single assay. This dual-target design provides a comprehensive diagnostic picture that supports appropriate clinical decision-making, particularly in pregnant women and immunocompromised patients where determining the timing of infection is critical.

Fast Results – 15 Minutes

The GHM TOXO IgG/IgM Rapid Test US provides qualitative results in 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Traditional laboratory-based serological testing for toxoplasmosis can be time-consuming and resource-intensive. Rapid results enable immediate clinical assessment, which is particularly valuable in prenatal screening settings where timely identification of seronegative pregnant women allows for appropriate preventive counseling and monitoring.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM TOXO IgG/IgM Rapid Test US is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios.

Clinical Utility – Aid for Diagnosis of Toxoplasma gondii Infection

The GHM TOXO IgG/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of Toxoplasma gondii infection. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management.

The dual-target design provides comprehensive diagnostic value across different clinical scenarios:

• IgM Positive: Indicates a recent or active infection. IgM antibodies typically appear during the first 2 weeks of acute infection, peak between the 4th and 8th weeks, and may persist for up to 18 months after acute infection.

• IgG Positive: Indicates past exposure or immunity to T. gondii. IgG antibodies appear more slowly, reach peak levels in 1–2 months, and can remain elevated and stable for months or years.

• IgM & IgG Positive: Suggests a current or ongoing infection, with both early and late-stage antibodies present.

The test is particularly valuable in prenatal screening programs, where determining maternal serostatus is essential for identifying seronegative women who require preventive counseling and serological monitoring during pregnancy. In cases where both IgG and IgM are positive in a pregnant patient, an IgG avidity test should be requested to further evaluate the timing of infection.

High Accuracy – Trusted Clinical Performance

The GHM TOXO IgG/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid Toxoplasma antibody tests have demonstrated strong performance for IgG detection, with sensitivities reaching 100% across multiple point-of-care test platforms.

Performance characteristics based on product specifications. Published evaluations of Toxoplasma point-of-care tests have demonstrated IgG sensitivity of 100% (170/170; 95% CI, 97.8%–100%) across three POC kits, with specificities ranging from 96.3% to 98.8%. Sensitivity for Toxoplasma IgM detection varies significantly across POC tests, ranging from 28% to 100% depending on the product and test format. A field evaluation of a rapid diagnostic test for toxoplasmosis in pregnant women in Cotonou, Benin reported sensitivity of 97% and specificity of 100% for IgG detection. Detection is optimal in specimens collected at appropriate time points during infection, and the test is best suited for use as an aid in the diagnosis of T. gondii infection in symptomatic patients and for prenatal screening. The test provides a preliminary result; confirmatory testing with reference laboratory methods and IgG avidity testing (when indicated) is recommended.

ISO 13485 Certified – Quality and Safety Compliance

The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.

CE Marked – European Conformity

The GHM TOXO IgG/IgM Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.

Product Specifications

Important Testing Notes:

• Allow the test kit and sample to reach room temperature (18–30°C) prior to testing.

• For fingerstick whole blood, clean the fingertip with an alcohol swab and allow it to dry; collect blood using a sterile lancet.

• Any visible shade of color in the Test line (T1 or T2) indicates a positive result, as intensity varies with antibody concentration.

• A negative result does not rule out Toxoplasma gondii infection, particularly during the early window period before antibodies become detectable or in immunocompromised patients.

• In pregnant women with both IgG and IgM positive, IgG avidity testing should be requested to further evaluate the timing of infection.

• Confirmatory testing at a reference laboratory with expertise in toxoplasmosis diagnosis is recommended for any reactive specimen.

Why Clinical Professionals Choose Global Healthcare Medical

About Global Healthcare Medical

Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM TOXO IgG/IgM Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.

Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.