GHM HSV-2 IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Herpes Simplex Virus Type 2 IgG & IgM Antibodies with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM HSV-2 IgG/IgM Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM HSV-2 IgG/IgM Rapid Test US is a lateral flow chromatographic immunoassay designed for the simultaneous detection and differentiation of IgG and IgM antibodies to Herpes Simplex Virus Type 2 (HSV-2) 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 HSV-2 infection.

Herpes simplex virus type 2 (HSV-2) is a prevalent, lifelong sexually transmitted infection and the primary cause of genital herpes worldwide. An estimated 520 million people aged 15–49 (13%) globally are living with HSV-2 infection. Global HSV-2 prevalence declined from 13.5% in 1980 to 13.0% in 2005, then increased to 13.6% in 2025 and is projected to reach 15.9% by 2050. Annual new infections increased from 15.0 million in 1980 to 27.7 million in 2025 and are projected to reach 37.6 million by 2050. The number of individuals experiencing genital ulcer disease increased from 95.0 million in 1980 to 179.0 million in 2025 and is projected to reach 250.7 million by 2050. Notably, up to 70% of women in some regions such as Tanzania are infected by age 30.

Most HSV infections are asymptomatic or unrecognized, but symptoms can include painful, recurring blisters or ulcers. Many people are unaware they have the infection and can pass along the virus to others without knowing. Infection with HSV-2 also increases the risk of acquiring and transmitting HIV infection. Because clinical presentation overlaps significantly with other sexually transmitted infections, laboratory confirmation is essential for accurate diagnosis and appropriate patient management.

The GHM HSV-2 IgG/IgM Rapid Test US delivers qualitative results in 10 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 STI clinics, primary care settings, and clinical laboratories.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including STI clinics, primary care 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 HSV-2 IgG/IgM Rapid Test US utilizes a lateral flow chromatographic immunoassay capable of simultaneously detecting and differentiating HSV-2 IgG and IgM antibodies from a single patient sample. The test incorporates two separate test lines: the IgG line is coated with antibody for the detection of IgG anti-HSV-2, and the IgM line is coated with antibody for the detection of IgM anti-HSV-2, enabling clear differentiation between recent/acute infection and past infection or immunity in a single assay. This dual-target design provides a comprehensive diagnostic picture that supports appropriate clinical decision-making.

Fast Results – 10 Minutes

The GHM HSV-2 IgG/IgM Rapid Test US provides qualitative results in 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. The HSV IgG, IgM, IgG/IgM Rapid tests are rapid chromatographic immunoassays providing results in 10–15 minutes with high sensitivity and specificity. Rapid results enable immediate clinical assessment and support same-visit patient management.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM HSV-2 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 HSV-2 Infection

The GHM HSV-2 IgG/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of HSV-2 infection. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management.

The dual-target design provides comprehensive diagnostic value:

• IgG Positive, IgM Negative: Indicates past exposure to HSV-2, suggesting established infection. Type-specific HSV-2 IgG antibody testing can determine if a person has HSV-2 infection, which is particularly important because most HSV infections are asymptomatic and many people are unaware they have the infection.

• IgM Positive: Indicates a recent or acute HSV-2 infection. IgM antibodies are typically detectable during acute or recent infection.

• IgG & IgM Positive: Suggests a current or ongoing infection, with both early and late-stage antibodies present. Use of IgM in addition to IgG testing can increase HSV-2 seroconversion detection from 47% to 70%.

The test is particularly valuable in settings where rapid identification of HSV-2 infection supports timely clinical decision-making and appropriate patient counseling. Healthcare professionals should consider asking all pregnant women at the first prenatal visit whether they or their sex partner(s) have had genital herpetic lesions, as knowledge of HSV-2 status may prove useful for the prevention of primary HSV-2 infections in pregnancy. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited. Point-of-care tests to detect HSV-2 antibodies are commercially available and can be valuable diagnostic tools in low-resource settings.

High Accuracy – Trusted Clinical Performance

The GHM HSV-2 IgG/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid HSV-2 antibody tests have demonstrated strong performance across multiple independent studies.

Performance characteristics based on published evaluations of rapid HSV-2 antibody tests. HSV-2 IgG sensitivity of 95.1% (95% CI: 90.0–98.1%) and specificity of 98.2% have been reported for point-of-care lateral flow immunoassays. Independent evaluations of HSV-2 IgG/IgM rapid tests have reported sensitivities of 93.8% and specificities of 96.0% for anti-HSV-2 IgG detection. A validation study of two HSV-2 POC tests in rural Tanzania reported sensitivities ranging from 30.3% to 69.7% and specificities ranging from 87.0% to 100%, highlighting the importance of selecting validated tests for clinical use. Type-specific HSV-2 IgG antibody detection is the preferred method for identifying HSV-2 infection. 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 HSV-2 infection. The test provides a preliminary result; confirmatory testing with reference laboratory methods 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 HSV-2 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 (IgG or IgM) indicates a positive result, as intensity varies with antibody concentration.

• A negative result does not rule out HSV-2 infection, particularly during the early window period before antibodies become detectable. Seroconversion typically occurs 2 to 3 weeks after infection.

• IgM results should be interpreted cautiously; false-positive IgM results may occur due to autoantibodies, serum binding proteins, heterophile antibodies, or cross-reactivity with other herpesviruses. The single-type HSV-1 and HSV-2 IgM ELISAs did not reliably detect HSV-1- and HSV-2-specific IgM antibodies in some evaluations.

• Type-specific HSV-2 IgG antibody detection is the preferred method for identifying HSV-2 infection.

• Confirmatory testing at a reference laboratory with expertise in HSV-2 diagnosis is recommended for any reactive specimen before clinical intervention.

• The U.S. Preventive Services Task Force recommends against routine blood testing for HSV in people without symptoms, including pregnant people, because the harms associated with false-positive results and unnecessary treatments outweigh the benefits for population-based screening. Testing should be performed based on clinical judgment and individual risk assessment.

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 HSV-2 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.