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

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

Product Overview

Global Healthcare Medical GHM CMV IgG/IgM Rapid Test US is a lateral flow chromatographic immunoassay designed for the simultaneous detection and differentiation of IgG and IgM antibodies to Cytomegalovirus (CMV) 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 CMV infection.

Cytomegalovirus (CMV) is a member of the herpesvirus family and is the most common cause of congenital viral infection worldwide, affecting approximately 1 in 200 live-born infants in high-income countries and 1 in 71 in low- and middle-income countries. CMV is a leading cause of non-hereditary sensorineural hearing loss and neurodevelopmental delay in children, and congenital CMV infection can result in microcephaly, brain abnormalities, intellectual disability, and vision impairment. The global seroprevalence of CMV IgG is estimated at 83.16% (95% CI: 78.55–87.77%), while CMV IgM seroprevalence is 13.77% (95% CI: 11.59–15.95%). Among women of childbearing age (16–45 years), CMV seroprevalence is approximately 61.2%, and approximately half of the female population in the US and three-quarters in Canada enter their reproductive years immunologically naive to CMV.

CMV infection during pregnancy—particularly primary infection in the first trimester—poses the greatest risk of harm to the fetus. Because the clinical presentation of CMV infection overlaps significantly with other viral illnesses, and CMV IgG testing is reliable for determining immune status and is appropriate for antenatal screening and transplant risk stratification, laboratory confirmation is essential for accurate diagnosis. The test can differentiate between acute (IgM) and past (IgG) CMV infections, supporting diagnosis and management of CMV-related complications, especially in pregnant women and immunocompromised individuals.

The GHM CMV 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.

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, transplant clinics, 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 CMV IgG/IgM Rapid Test US utilizes a lateral flow chromatographic immunoassay capable of simultaneously detecting and differentiating CMV IgG and IgM antibodies from a single patient sample. The test incorporates two separate test lines: the T1 line is coated with antibody for the detection of IgM anti-CMV, and the T2 line is coated with antibody for the detection of IgG anti-CMV, 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, particularly in pregnant women, transplant recipients, and immunocompromised patients.

Fast Results – 10 Minutes

The GHM CMV 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. 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 serological monitoring during pregnancy.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM CMV 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. Both fingerstick whole blood and venipuncture whole blood can be used. 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 CMV Infection and Immunity Assessment

The GHM CMV IgG/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of CMV infection and immunity assessment. 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 CMV, suggesting immunity. This is valuable for identifying seropositive women who have pre-existing immunity and for determining immune status prior to immunosuppressive therapy or organ transplantation.

• IgM Positive: Indicates a recent or acute CMV infection. CMV 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. In pregnant women with both IgG and IgM positive, IgG avidity testing should be requested to further evaluate the timing of infection, as CMV IgG avidity testing is a more reliable marker of primary infection.

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. Women may get CMV infection for the first time during pregnancy (primary infection) or may experience 'non-primary' infection, either by reactivation of previous CMV infection or by a new infection with a different strain of the virus. Serological tests for detecting the presence of antibody to CMV can provide valuable information regarding the history of previous infection, diagnosis of active or recent infection, as well as in screening blood for transfusions in newborns and immuno-compromised recipients.

High Accuracy – Trusted Clinical Performance

The GHM CMV IgG/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. The test demonstrates high sensitivity and specificity for the detection of CMV antibodies in serum and plasma.

Performance characteristics based on published evaluations of rapid CMV antibody tests. Independent evaluations of CMV IgG/IgM rapid tests have reported sensitivities of 93.3% (IgM) and 90.0% (IgG), with specificities of 98.5% (IgM) and 98.1% (IgG), and accuracies of 98.0% (IgM) and 97.3% (IgG). Studies have demonstrated that CMV IgG testing is reliable for determining immune status and is appropriate for antenatal screening, transplant risk stratification, and evaluation of immunocompromised individuals, while IgM assays show significant variability and fair-to-moderate inter-assay concordance, reinforcing current recommendations that IgM results should be interpreted cautiously and supplemented with confirmatory testing such as IgG avidity or molecular assays. 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 CMV infection in symptomatic patients and for immunity assessment. 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 CMV 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 CMV infection, particularly during the early acute phase of infection before antibodies become detectable, or if the specimen was collected too early or too late after infection.

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

• All babies born to women with confirmed or suspected CMV infection should be tested for CMV with a urine or saliva sample within the first 21 days of life.

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

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 CMV 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.