(CMV) Cytomegalovirus IgM/IgG Antibody Rapid Test

Name: (CMV) Cytomegalovirus IgM/IgG Antibody Rapid Test
SKU: DST-H018
Rating: 5 (1 reviews)

Regulatory status: For research use only, not for use in diagnostic procedures.

COA

SDS

Datasheet

Summary

Sample

Serum, plasma

Species Reactivity

Human

Intended Use

The reagent is used for the qualitative detection of CMV-IgM/IgG antibody in human serum/plasma.

Contents of Kit

Sample pad, colloidal gold conjugate pad, nitrocellulose membrane, absorbent paper and PVC board. Colloidal gold conjugate pad labeled with CMV recombinant antigen, Biotinylated BSA. T1-line coated with mouse anti-human IgG monoclonal antibody, T2-line coated with mouse anti-human IgM monoclonal antibody, control line coated with streptavidin-conjugated IgG.
Disposable plastic straws (optional)

Storage

Store in a dry environment at 4-30°C, avoid hot and sunshine, valid for 36 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.

Performance Characteristics

1. Using internal quality control samples
a. Negative reference: The results should all be negative when detecting the negative quality control samples.
b. Positive reference: The results should all be positive when detecting the positive quality control samples.
c. Limit of detection: The results should all be positive when detecting the limit of detection samples.
b. Repeatability: The repeatability sample is tested by 10 kits, and the results should be all positive and the coloration degree should be consistent.
2. Clinical trial results
A clinical evaluation was conducted on 1110 samples comparing the results obtained using the Cytomegalovirus IgM/IgG Antibody Rapid Test and other commercially available CMV-IgM/IgG tests.
CMV-IgM

PPA: 95.97% (95%CI: 90.91%-98.27%)
NPA: 99.59% (95%CI: 98.96%-99.84%)
OPA: 99.19% (95%CI: 98.47%-99.57%)
CMV-IgG

PPA: 98.59% (95%CI: 97.42%-99.23%)
NPA: 98.50% (95%CI: 96.77%-99.31%)
OPA: 98.56% (95%CI: 97.67%-99.11%)
Explanation of Terms
PPA: Positive Percent Agreement = True Positives/(True Positives + False Negatives)
NPA: Negative Percent Agreement = True Negatives/(True Negatives + False Positives)
OPA: Overall Percent Agreement = (True Positives + True Negatives)/Total
CI: Confidence Interval
3. Analytical specificity
a. Cross-reactivity: By testing HBV, RF and ASO, there are no effect on the test result.
b. Interfering Substances: 1000μmol/L bilirubin, 5.65mmol/L triglyceride, 10g/L hemoglobin have no effect on the test result.

Citations

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Background

Cytomegalovirus (CMV) is one of the largest and most common latent persistent viruses. Most people are infected with CMV early in life. CMV can remain latent in an immunocompetent person for decades with no noticeable symptoms, and the virus reactivates and causes disease when the immune system fails.

The most common congenital infection worldwide is human CMV congenital infection. If a pregnant woman is infected with CMV for the first time during pregnancy, it can be transmitted to the fetus through the placenta leading to congenital CMV infection. Some researchers estimate that 0.48% of fetuses in high-income countries are affected by CMV, while 1.42% of fetuses in low- and middle-income countries are infected by CMV. Congenital CMV infection is one of the leading causes of congenital deafness and neurodevelopmental disorders, in addition to microcephaly, jaundice, hepatosplenomegaly, vision and hearing impairments, and even mental retardation in newborns. On the other hand, in immunocompromised patients due to various factors (organ transplantation, HIV infection, chemotherapy) CMV can lead to serious complications including pneumonia, hepatitis, enteritis, retinitis and other fatal diseases. Therefore, prophylactic antiretroviral therapy and regular monitoring of CMV load are needed in this high-risk group.

Currently, treatments for CMV mainly rely on antiviral drugs, which can effectively inhibit viral replication, such as cidofovir and ganciclovir. In addition to conventional antiviral drug therapy, researchers are trying to develop some innovative treatments, such as nucleic acid-based gene-targeted therapies and cellular therapies, but these treatments may have limitations on the patient populations in which they can be used. There is no effective CMV vaccine to achieve prevention, but the risk of contracting CMV can be reduced through good hygiene practices, including washing hands frequently and taking proper precautions when handling diapers and sanitary items.

Antiviral drugs for CMV Figure 1. Mechanism of action of anti-CMV therapies
(Source: Walti CS, et al. 2023)

Alternative Names

CMV IgM/IgG

References

1. Jones CE, et al. Managing challenges in congenital CMV: current thinking. Arch Dis Child. 2023 Aug;108(8):601-607.
2. Chen SJ, et al. Challenges, Recent Advances and Perspectives in the Treatment of Human Cytomegalovirus Infections. Trop Med Infect Dis. 2022 Dec 14;7(12):439.
3. Walti CS, et al. New Treatment Options for Refractory/Resistant CMV Infection. Transpl Int. 2023 Oct 12;36:11785.

Documents

pdf COA

pdf SDS

pdf Datasheet

QA & Reviews

Customer Reviews

References

Managing challenges in congenital CMV: current thinking

Arch Dis Child

Authors: Jones CE, Bailey H, Bamford A, Calvert A, Dorey RB, Drysdale SB, Khalil A, Heath PT, Lyall H, Ralph KMI, Sapuan S, Vandrevala T, Walter S, Whittaker E, Wood S; UK Congenital CMV Infection Collaboration (UKCCIC).

Abstract

Congenital human cytomegalovirus (CMV) infection is the most common congenital infection, affecting around 1 in 200 infants in high-income settings. It can have life-long consequences for up to one in four children, including sensorineural hearing loss and neurodisability. Despite the frequency of congenital CMV and the severity for some children, it is a little-known condition by pregnant women, families and healthcare providers. Timely diagnosis of CMV infection in pregnancy is important to facilitate consideration of treatment with valaciclovir, which may reduce the risk of transmission to the fetus or reduce the severity of the outcomes for infected infants. Recognition of features of congenital CMV is important for neonatologists, paediatricians and audiologists to prompt testing for congenital CMV within the first 21 days of life. Early diagnosis gives the opportunity for valganciclovir treatment, where appropriate, to improve outcomes for affected infants. Further research is urgently needed to inform decisions about antenatal and neonatal screening, long-term outcomes for asymptomatic and symptomatic infants, predictors of these outcomes and optimal treatment for women and infants.

Patterns of CMV infection after letermovir withdrawal in recipients of posttransplant cyclophosphamide-based transplant

Blood Adv

Authors: Lin A, Brown S, Chinapen S, Lee YJ, Seo SK, Ponce DM, Shahid Z, Giralt S, Papanicolaou GA, Perales MA, Shaffer BC.

Abstract

Reactivation of latent cytomegalovirus (CMV) is increased in recipients of allogeneic hematopoietic cell transplantation (allo-HCT) with seropositive CMV using posttransplant cyclophosphamide (PT-Cy)-based graft-versus-host disease (GVHD) prophylaxis. Letermovir, a novel DNA terminase complex inhibitor, reduces the incidence of clinically significant CMV infection (csCMVi) in this population; however, parameters that predict csCMVi after letermovir withdrawal are not well described. Here, we examined clinical and immunological parameters in 294 recipients of PT-Cy-based allo-HCT, including 157 patients with CMV, of whom 80 completed letermovir prophylaxis without csCMVi and subsequently stopped letermovir. In this population, the median duration of letermovir exposure was 203 days (interquartile range [IQR], 160-250 days). After letermovir withdrawal, the 90-day cumulative incidence of csCMVi was 23.0% (95% confidence interval, 14.3-32.8). There were no episodes of CMV end-organ disease. Hypogammaglobulinemia before letermovir discontinuation was predictive of csCMVi (hazard ratio, 0.33; 95% confidence interval, 0.12-0.93; P = .03), whereas T-cell and B-cell reconstitution before letermovir withdrawal were not predictive of csCMVi. Higher numbers of natural killer cells were found before letermovir withdrawal in patients who experienced csCMVi (median, 202 vs 160; P = .03). In recipients with seropositive CMV, CD3+CD4-CD8+ T-cell reconstitution was faster in patients with CMV regardless of letermovir exposure. Taken together, these data suggest that csCMVi after letermovir withdrawal was frequent in patients treated with PT-Cy, despite prolonged exposure. Strategies to boost CMV-specific adaptive immunity in patients with persistent hypogammaglobulinemia is a logical pathway to reduce csCMVi after letermovir withdrawal.