Development and Clinical Evaluation of a Recombinant-Antigen-Based Cytomegalovirus Immunoglobulin M Automated Immunoassay Using the Abbott AxSYM Analyzer

Maine, Gregory T.; Stricker, René; Schüler, Martin; Spesard, Jack; Brojanac, S.; Iriarte, Beimar; Herwig, Karl R.; Gramins, T.; Combs, B.; Wise, Jacqui; Simmons, Hugh; Gram, T.; Lonze, J.; Ruzicki, D.; Byrne, Barry; Clifton, J. D.; Chovan, Linda E.; Wachta, D.; Holas, C.; Wang, D.; Wilson, Tracy; Tomazic-Allen, Susan; Clements, Mary Ann; Wright, George L.; Lazzarotto, Tiziana; Ripalti, Alessandro; Landini, Maria Paola

doi:10.1128/jcm.38.4.1476-1481.2000

Cited by 38 publications

(11 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The detection limit depends upon the immune status of the patients and the sensitivity of the use assay [31]. This is in agreement with previous reports [31,32]. However the low sensitivity of this test slightly improved by the calculating cut of levels of IgM165Iu/ml with 54% sensitivity specificity 58%.…”

Section: Discussionsupporting

confidence: 90%

Molecular Study of Cytomegalovirus Infection among Children with End Stage Renal Diseases Undergoing Dialysis, Pilot Study

2017

Medical &Amp; Clinical Research

View full text Add to dashboard Cite

Cytomegalovirus is considered as an opportunistic infection affecting immunocompromized patients. Children with end stage renal diseases requiring dialysis is among affected population by this virus. The aim of the present study was to detect and compare the seroprevalence of CMV and CMV antigen pp65 with real time polymerase chain reaction (PCR) among children with end stage renal diseases undergoing dialysis. The study is a prospective case - control study. The forty one patients included in the studied are registered in the hospital for regular dialysis waiting for renal transplantation. The study included forty one healthy controls with same age and gender distribution. Blood samples were obtained from studied children and subjected for determination of specific immunoglobulin M and G for CMV (IgM-CMV, IgG-CMV) by Elecys system and CMV-DNA determination by real time polymerase chain reaction (PCR) and for PP65 antigenaemia test by light diagnostic CMVpp65. CMV-IgM was significantly detected frequently (P=0.0001) in 12.2% of the patients and in 2.4% of the control children. Moreover, IgG-CMV was significantly more frequently detected in patients (P=0.0001) than in control (90.2%&31.7% respectively). CMV-DNA was significantly (P=0.0001) detected in 12 patients (29.3%) compared to the control (2.4%), while CMVpp65 was detected among 4 children (9.8%) compared to one child in the control group. The comparison between IgM-CMV and real time PCR revealed that 30.7% of positive samples by PCR had positive IgMCMV, while IgG-CMV was associated with 84.6% of positive PCR. CMVpp65 correctly identified all negative samples compared to PCR, while the majority of negative PCR was also negative for IgM-CMV (98.6%). Moreover, all negative children for CMVpp65 was also negative by PCR (100%) For the validity of different CMV markers, IgG-CMV was the most sensitive test (84.7%), CMVpp65 was the most specific test 100%. From this study we concluded that CMV is a common viral infection among children with end stage renal diseases requiring dialysis. The diagnostic performance of real time PCR is the gold standard technique in diagnosis of this infection. CMVpp65 antigenemia is a specific accurate test for laboratory diagnosis however, it lacks sensitivity. Specific IgG for CMV is good screening diagnostic test.

show abstract

Section: Discussionsupporting

confidence: 90%

Molecular Study of Cytomegalovirus Infection among Children with End Stage Renal Diseases Undergoing Dialysis, Pilot Study

2017

Medical &Amp; Clinical Research

View full text Add to dashboard Cite

show abstract

“…Moreover, false positive CMV IgM results can occur in the course of non-CMV illnesses such as primary Epstein-Barr virus infection due to potent B-cell stimulation. Furthermore, studies have demonstrated a high variability in specificity and sensitivity among CMV IgM assays in addition to a high rate of discordance [ 10 , 11 ]. Thus, testing for IgM, particularly in asymptomatic pregnant women, may frequently create a problem rather that solving it.…”

Section: Introductionmentioning

confidence: 99%

Primary Cytomegalovirus Infection in Pregnant Egyptian Women Confirmed by Cytomegalovirus IgG Avidity Testing

et al. 2013

View full text Add to dashboard Cite

Objective: To determine the frequency of primary cytomegalovirus (CMV) infection in pregnant Egyptian women using CMV IgG avidity testing. Subjects and Methods: A cross-sectional study was conducted at Suez Canal University Hospital, Ismailia, Egypt. A total of 546 pregnant women, presenting for routine antenatal screening, were tested for CMV IgG and IgM using a commercially available enzyme-linked immunosorbent assay (ELISA). Sera from CMV IgM-positive women were tested by CMV IgG avidity assay. Results: All the 546 pregnant women were seropositive for anti-CMV IgG. Of the 546 women, 40 (7.3%) were positive or equivocal for IgM antibodies. All sera from the 40 women (IgG+/IgM+) showed a high or intermediate CMV IgG avidity index. Of the 40 women, 23 (57.5%) were in the second or third trimesters of pregnancy and had their first-trimester blood retrieved, and the tested CMV IgG avidity assay showed a high avidity index. Conclusion: Women who were IgM positive had no primary CMV infection in the index pregnancy as evidenced by the high CMV IgG avidity testing.

show abstract

“…19 In general the majority of positive IgM results (even highly sensitive CMV IgM tests) may have some false positive results. 20,21 At the time of writing, it is not possible to distinguish between primary CMV infection and reinfection with a different strain using serology. Whole genome sequencing and comparative analysis may potentially be helpful but this is currently limited by cost and difficulties with interpretation.…”

Section: Diagnosis Of Maternal Infectionmentioning

confidence: 99%

“…In the absence of documented recent seroconversion, it is difficult or impossible to distinguish between primary and nonprimary infection as both can be associated with a four‐fold rise in IgG titres and the presence of IgM antibodies . In general the majority of positive IgM results (even highly sensitive CMV IgM tests) may have some false positive results . At the time of writing, it is not possible to distinguish between primary CMV infection and reinfection with a different strain using serology.…”

Section: Diagnosis Of Maternal Infectionmentioning

confidence: 99%

Comprehensive review and update of cytomegalovirus infection in pregnancy

Navti

Hughes

Tang

et al. 2016

The Obstetric & Gynaecologis

View full text Add to dashboard Cite

Key Content Cytomegalovirus (CMV) is the most common cause of congenital viral infections; 75–90% of infections are asymptomatic at birth but 10–25% of infants will develop neurological sequelae. Diagnosis of primary maternal CMV in pregnancy should be based on seroconversion in pregnancy (de novo appearance of virus‐specific immunoglobulin G [IgG] in the serum of pregnant women who were previously seronegative) or on detection of specific immunoglobulin M (IgM) and IgG antibodies in association with low IgG avidity. Primary maternal infection is associated with a 30–40% risk of intrauterine transmission and fetal infection, with 20–25% of those infected developing sequelae postnatally. Prenatal diagnosis of fetal CMV is imperfect and based on amniocentesis performed at least 7 weeks after presumed maternal infection and after 21 weeks of gestation. The presence of radiologic findings by ultrasound in combination with CMV DNA viral load in amniotic fluid may have prognostic significance for risk of neurologic sequelae. Learning objectives To understand the prevalence, diagnosis and implications of CMV infection in pregnancy. To explore the management options in a pregnancy affected by congenital CMV. Ethical issues Should routine screening for CMV be recommended in pregnancy? How should termination counselling be conducted following prenatal confirmation of fetal infection with amniocentesis?

show abstract

Development and Clinical Evaluation of a Recombinant-Antigen-Based Cytomegalovirus Immunoglobulin M Automated Immunoassay Using the Abbott AxSYM Analyzer

Cited by 38 publications

References 27 publications

Molecular Study of Cytomegalovirus Infection among Children with End Stage Renal Diseases Undergoing Dialysis, Pilot Study

Molecular Study of Cytomegalovirus Infection among Children with End Stage Renal Diseases Undergoing Dialysis, Pilot Study

Primary Cytomegalovirus Infection in Pregnant Egyptian Women Confirmed by Cytomegalovirus IgG Avidity Testing

Comprehensive review and update of cytomegalovirus infection in pregnancy

Contact Info

Product

Resources

About