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

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

Product Overview

Global Healthcare Medical GHM Rubella IgG/IgM Rapid Test US is a lateral flow chromatographic immunoassay designed for the simultaneous detection and differentiation of IgG and IgM antibodies to rubella virus (RV) 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 rubella virus infection and immunity assessment.

Rubella is an acute respiratory infection caused by the rubella virus (RV), including congenital infection and acquired infection. Clinical features include short precursors, low fever, rash, and occipital lymph node enlargement. The general condition is mild, the course of the disease is short, and the prognosis is good. However, rubella is very easy to cause outbreaks, which can happen throughout the year, with many diseases in winter and spring. The susceptible age is mainly 1–5 years old, so the prevalence is prevalent in preschool children. Although the clinical symptoms are mild, the virus can infect the fetus through the fetal blood barrier. Both overt and non-dominant infection can lead to congenital rubella syndrome (CRS), such as congenital fetal malformation, stillbirth, premature birth, etc. Therefore, the early diagnosis and prevention of rubella are very important.

Rubella virus infection during early pregnancy can result in miscarriage, fetal death, stillbirth, or a constellation of birth defects. The estimated number of CRS births globally declined by approximately two-thirds during 2010–2019, from 100,000 (95% CI: 54,000–166,000) to 32,000 (95% CI: 22,000–48,000). By the end of 2023, 19 lower- and middle-income countries had not yet introduced rubella-containing vaccine (RCV). In 2019, an estimated 24,000 CRS cases occurred in these countries, representing 75% of the estimated 32,000 cases worldwide. Following the COVID-19 pandemic, reported rubella case numbers increased from 10,021 cases in 2021 to 35,714 in 2023.

The clinical presentation of rubella overlaps significantly with other exanthematous diseases, making laboratory confirmation essential for accurate diagnosis. Rubella-specific IgG and IgM antibodies are observed about 14–18 days after rubella infection, at about the time when the rash appears. Rubella IgM antibodies are typically detectable between 4 and 30 days after rash onset in acute rubella infection and for up to six months after birth in CRS cases. Rubella IgG antibodies become detectable by day four after rash onset and reach peak levels in the following one to two weeks. Detection of specific IgM antibodies is widely used for acute case investigation, but also to confirm CRS cases in infants aged 6 months or younger.

The GHM Rubella 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, pediatric 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 Rubella IgG/IgM Rapid Test US utilizes a lateral flow chromatographic immunoassay capable of simultaneously detecting and differentiating rubella virus 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-RV, and the IgM line is coated with antibody for the detection of IgM anti-RV, 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 and in assessing immune status before or during pregnancy.

Fast Results – 15 Minutes

The GHM Rubella 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. 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. The standard test to detect IgM antibodies is enzyme immunoassay (EIA), which requires laboratory and staff capacity, appropriate sample transport to the laboratory, and a turnaround time of several hours. Decentralized testing with easy-to-use point-of-care diagnostic assays such as rapid diagnostic tests (RDTs) could improve rubella surveillance and enable faster clinical decision-making.

Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection

The GHM Rubella 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 Rubella Virus Infection and Immunity Assessment

The GHM Rubella IgG/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of rubella virus 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 rubella virus or vaccination, suggesting immunity. This is particularly valuable for identifying seropositive women who have protection against rubella infection during pregnancy.

• IgM Positive: Indicates a recent or acute rubella virus infection. The immunocomplex is captured by the reagent coated on the IgM line, forming a colored IgM line, indicating a fresh infection.

• IgG & IgM Positive: Suggests a current or ongoing infection, with both early and late-stage antibodies present. The immunocomplex is then captured by the reagent pre-coated on the IgG line, forming a colored IgG line, indicating a positive test result and suggesting a recent or repeat 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. If a woman's immune status is unknown, her blood should be tested for rubella antibodies within 7 days of exposure. A prenatal diagnosis of congenital infection is recommended when a maternal infection is diagnosed and is based on the detection of RV-specific IgM antibodies. In congenital rubella, IgM becomes positive within one month of birth and is usually negative by twelve months.

High Accuracy – Trusted Clinical Performance

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

Performance characteristics based on published evaluations of rapid rubella antibody tests. An evaluation of the RapidFor Rubella IgG/IgM Rapid Test Kit reported sensitivity of 98.01% and specificity of 99.01% for rubella IgG compared with ELISA methods. Independent evaluations of rubella IgG/IgM rapid tests have reported sensitivities of 93.4% for IgM and 91.8% for IgG, with specificities of 99.0% for IgM and 98.7% for IgG, and accuracies of 98.1% for IgM and 97.6% for IgG. A systematic assessment of commercial lateral flow immunoassays for rubella IgM detection noted that most RDTs showed substantially lower analytical sensitivity than EIAs, detecting IgM only at higher antibody concentrations, and that results should be interpreted cautiously and confirmed by EIA, particularly in elimination settings. 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 rubella virus 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 Rubella 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 rubella virus infection, particularly during the early window period before antibodies become detectable, or if the specimen was collected too late after infection when IgM levels have declined.

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

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

• IgM may remain detectable for up to 6 months after acute infection and may occasionally be detected for months and even years after vaccination.

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 Rubella 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.