Incidence Of Congenital Cytomegalovirus Infection Research Articles

Safety, efficacy, and immunogenicity of a replication-defective human cytomegalovirus vaccine, V160, in cytomegalovirus-seronegative women: a double-blind, randomised, placebo-controlled, phase 2b trial

A vaccine that prevents cytomegalovirus (CMV) infection in women could reduce the incidence of congenital CMV infection, a major cause of neurodevelopmental disability. We aimed to assess the safety and efficacy of a replication-defective investigational CMV vaccine, V160, in CMV-seronegative women. This phase 2b, randomised, double-blind, placebo-controlled study was conducted at 90 sites in seven countries (USA, Finland, Canada, Israel, Spain, Russia, and Australia). Eligible participants were generally healthy, CMV-seronegative, non-pregnant, 16-35-year-old women of childbearing potential with exposure to children aged 5 years or younger. Participants were randomly assigned using central randomisation via an interactive response technology system 1:1:1 to one of three groups: V160 three-dose regimen (V160 at day 1, month 2, and month 6), V160 two-dose regimen (V160 on day 1, placebo at month 2, and V160 at month 6), or placebo (saline solution at day 1, month 2, and month 6). The primary outcomes were the efficacy of three doses of V160 in reducing the incidence of primary CMV infection during the follow-up period starting 30 days after the last dose of vaccine using a fixed event rate design, and the safety and tolerability of the two-dose and three-dose V160 regimens. We planned to test the efficacy of a two-dose regimen of V160 in reducing the incidence of primary CMV infection only if the primary efficacy hypothesis was met. Analyses for the primary efficacy endpoint were performed on the per-protocol efficacy population; safety analyses included all randomly assigned participants who received study vaccine. The primary efficacy hypothesis was tested at prespecified interim and final analyses. The study was ongoing and efficacy data continued to accrue at the time of final testing of the primary efficacy hypothesis. Vaccine efficacy was re-estimated after final testing of the primary efficacy hypothesis based on all available efficacy data at end of study. This trial is registered at ClinicalTrials.gov (NCT03486834) and EudraCT (2017-004233-86) and is complete. Between April 30, 2018, and Aug 30, 2019, 7458 participants were screened, of whom 2220 were randomly assigned to the V160 three-dose group (n=733), V160 two-dose group (n=733), or placebo group (n=734). A total of 523 participants in the V160 three-dose group and 519 in the placebo group were included in the final hypothesis testing. Of these, there were 11 cases of CMV infection in the V160 three-dose group and 20 cases in the placebo group. The vaccine efficacy for the V160 three-dose group was 44·6% (95% CI -15·2 to 74·8) at the final testing of the primary efficacy hypothesis, a result corresponding to failure to demonstrate the primary efficacy hypothesis. On the basis of this result, the study was terminated for futility. The re-estimate of vaccine efficacy for the V160 three-dose group based on all available efficacy data at end of study (556 participants in the V160 three-dose group and 543 in the placebo group) was 42·4% (95% CI -13·5 to 71·1). A total of 728 participants in the V160 three-dose group, 729 in the V160 two-dose group, and 732 in the placebo group were included in the safety analyses. The most common solicited injection-site adverse event was injection-site pain (680 [93%] in the V160 three-dose group, 659 [90%] in the V160 two-dose group, and 232 [32%] in the placebo group). The most common solicited systemic adverse event was fatigue (457 [63%] in the V160 three-dose group, 461 [63%] in the V160 two-dose group, and 357 [49%] in the placebo group). No vaccine-related serious adverse events or deaths were reported. V160 was generally well tolerated and immunogenic; however, three doses of the vaccine did not reduce the incidence of primary CMV infection in CMV-seronegative women compared with placebo. This study provides insights into the design of future CMV vaccine efficacy trials, particularly for the identification of CMV infection using molecular assays. Merck Sharp & Dohme, a subsidiary of Merck & Co, Rahway, NJ, USA (MSD).

Effectiveness and safety of prenatal valacyclovir for congenital cytomegalovirus infection: systematic review and meta-analysis.

Universal screening for cytomegalovirus (CMV) infection in pregnancy is not recommended in most countries. One of the major deterrents is the lack of effective prenatal therapy. The role of valacyclovir therapy in reducing the risk of vertical transmission, symptomatic congenital CMV infection and adverse outcome is controversial. The main aim of this systematic review and meta-analysis was to investigate the safety and effectiveness of prenatal valacyclovir therapy in pregnancies with maternal CMV infection. MEDLINE, EMBASE and Cochrane databases and ClinicalTrials.gov were searched. The inclusion criteria were pregnancy with confirmed maternal CMV infection, treated or untreated with valacyclovir. The primary outcome was the incidence of congenital CMV infection confirmed by a positive CMV polymerase chain reaction result of the amniotic fluid. The secondary outcomes were symptomatic and asymptomatic infection, perinatal death, termination of pregnancy, anomalies detected on follow-up ultrasound, on fetal magnetic resonance imaging or at birth, severe and mild-to-moderate symptoms due to congenital CMV infection, neurological, visual and hearing symptoms, and adverse events related to valacyclovir. Risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2) or Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool, as appropriate. Head-to-head meta-analyses were used to compare the risk of each of the explored outcomes according to whether pregnancies with maternal CMV infection were treated with prenatal valacyclovir therapy. Eight studies (620 women) were included. Pregnancies treated with valacyclovir had a significantly lower risk of congenital CMV infection compared with those not receiving valacyclovir (three studies; 325 fetuses; pooled odds ratio (OR), 0.37 (95% CI, 0.21-0.64); I2 = 0%; P < 0.001). When stratifying the analysis according to gestational age at maternal infection, the risk of vertical transmission was significantly lower in pregnancies receiving valacyclovir following first-trimester maternal infection (three studies; 184 fetuses; pooled OR, 0.34 (95% CI, 0.15-0.74); I2 = 20.9%; P = 0.001), while there was no significant difference between the two groups in those acquiring CMV infection in the periconceptional period or in the third trimester of pregnancy. Only one study reported on the risk of vertical transmission in women infected in the second trimester, demonstrating a lower risk of congenital infection in women taking valacyclovir, although this was based on a small number of cases. Pregnancies treated with valacyclovir therapy had an increased likelihood of asymptomatic congenital CMV infection compared with those not receiving valacyclovir (two studies; 132 fetuses; pooled OR, 2.98 (95% CI, 1.18-7.55); I2 = 0%; P = 0.021), while there was no significant difference between the two groups in the risk of perinatal death (P = 0.923), termination of pregnancy (P = 0.089), anomalies detected at follow-up imaging assessment during pregnancy or at birth (P = 0.934) and symptoms due to CMV infection in the newborn (P = 0.092). The occurrence of all adverse events in pregnant individuals taking valacyclovir was 3.17% (95% CI, 1.24-5.93%) (six studies; 210 women), with 1.71% (95% CI, 0.41-3.39%) experiencing acute renal failure, which resolved after discontinuation of the drug. On GRADE assessment, the quality of evidence showing that valacyclovir reduced the risk of congenital CMV infection and adverse perinatal outcome was very low. Prenatal valacyclovir administration in pregnancies with maternal CMV infection reduces the risk of congenital CMV infection. Further evidence is needed to elucidate whether valacyclovir can affect the course of infection in the fetus and the risk of symptomatic fetal or neonatal infection. © 2022 International Society of Ultrasound in Obstetrics and Gynecology.

Maternal Facial Nerve Palsy and a Perinatal Infection.

Maternal Facial Nerve Palsy and a Perinatal Infection.

Congenital Cytomegalovirus Infection in Pregnancy: A Case Report with Sequential Fetal Brain Changes and the Latest Information on Diagnosis, Treatment and Prevention

Congenital cytomegalovirus (CMV) infection is the most common nongenetic cause of sensorineural hearing loss and a major cause of visual, intellectual, and neurodevelopmental impairment worldwide. The seroprevalence of CMV among women of childbearing age in developing countries reaches almost 100%, and the incidence of CMV infection in neonates is 1%–2%. Approximately 87% of the infected neonates are asymptomatic at birth and 13% of them have permanent sequelae. The burden of congenital malformations due to congenital CMV infection is higher than that due to Down syndrome, fetal alcohol syndrome, and spina bifida. Nevertheless, there is little knowledge regarding congenital CMV pathogenesis, diagnosis, treatment, and prevention. In this study, we report a case that showed sequential changes of fetal brain following CMV infection in pregnancy. Additionally, we reviewed the latest information on the diagnosis, treatment, and prevention of congenital CMV infection.

Congenital cytomegalovirus infection: Diagnosis, treatment, and prevention

Congenital cytomegalovirus infection is an infectious disease that results from antenatal transplacental transmission of cytomegalovirus to a fetus. The above virus is the most common cause of congenital infections worldwide. Congenital cytomegalovirus infection may develop both after primary infection of a seronegative pregnant women (primary) and due to reactivation of the virus or reinfection with other virus strains during pregnancy (non-primary). In the neonatal period, 85-90% of children infected in utero are observed to have an asymptomatic or subclinical course of the disease. In other cases, the clinical picture is characterized by lesions of various organs and by frequent CNS involvement. In its severe course, the disease is treated with antiviral drugs that are so far referred to as an “off-label” group. Even in the absence of symptoms in the neonatal period, the babies infected with CMV in utero may develop late sequels, with hearing loss being most common. Preschool hearing control and ophthalmologic and neurologic monitoring are recommended for the timely treatment and rehabilitation of late manifestations of congenital cytomegalovirus infection. The important strategy to reduce the incidence of congenital cytomegalovirus infection is its prevention in pregnant women, by disseminating information about the disease in the publicly accessible sources of information and by teaching simple hygienic practices.

Vertically transmitted cytomegalovirus infection in newborn preterm infants.

To determine the epidemiology of congenital and acquired cytomegalovirus (CMV) infections in preterm infants and to analyze the efficacy of breast milk freezing in decreasing the vertical transmission rate of CMV. During 2013 and 2014, preterm newborns who weighed ≤1500 g and were admitted to 22 Spanish neonatal units were included and screened for CMV infection according to the Spanish Neonatology Society recommendations. Each hospital treated the breast milk according to its own protocols. Among the 1236 preterm neonates included, 10 had a congenital infection (0.8%) and 49 had an acquired infection (4.0%) (82% demonstrated positive PCR-CMV in breast milk). The neonates who received only frozen milk presented less frequently with acquired infection (1.2%) than those fed fresh milk (5.5%) (RR=0.22; 95% CI 0.05-0.90; P=0.017). The newborns who received bank milk followed by frozen or fresh breast milk more frequently had an acquired infection (2.1% or 2.2%, respectively) than those fed only frozen breast milk. The incidence of congenital CMV infection in our sample is low, as described in the literature. To reduce acquired CMV infection, freezing breast milk might be an advisable procedure for preterm neonates born from seropositive mothers, either from the beginning of lactation or after a period of bank milk administration.

Incidence of congenital cytomegalovirus infection in Ireland: Implications for screening and diagnosis

BackgroundCongenital cytomegalovirus (cCMV) causes serious intrauterine infection and is the leading cause of sensorineural hearing loss. In the absence of routine screening, asymptomatic infections, which constitute approximately 90% of all cCMV cases, remain undiagnosed; however many clinical abnormalities manifest later in childhood. ObjectivesThe aims of the present study were to determine, for the first time, the incidence of cCMV infection in a large maternity hospital in Dublin city and the optimal sampling method for neonatal screening. Study designA pilot screening study of asymptomatic infants born was conducted over a 12-month period. Mothers were consented and neonates screened for evidence of CMV infection (n=1044). Urine or saliva was tested for the presence of CMV DNA and reactive results were confirmed with follow-up testing and clinical evaluation. ResultscCMV incidence in the asymptomatic neonates screened was 0.19%. An overall cCMV incidence was extrapolated based on the total number of live-births and data from those infants routinely screened for cCMV during the study period, and estimated as 0.23%. Neonatal urine collection proved prohibitive to mass screening. However, testing of saliva for CMV DNA was rapid, sensitive and suitable for screening. Furthermore, in a low prevalence population, pooling of patient samples proved effective and cost-efficient. ConclusionsThe present study concluded that there is a significant burden of undiagnosed cCMV infection in Ireland. The introduction of neonatal CMV DNA testing of saliva is viable, and could be considered as part of the national newborn screening programme, following a cost-benefit analysis.

The "silent" global burden of congenital cytomegalovirus.

Human cytomegalovirus (CMV) is a leading cause of congenital infections worldwide. In the developed world, following the virtual elimination of circulating rubella, it is the commonest nongenetic cause of childhood hearing loss and an important cause of neurodevelopmental delay. The seroprevalence of CMV in adults and the incidence of congenital CMV infection are highest in developing countries (1 to 5% of births) and are most likely driven by nonprimary maternal infections. However, reliable estimates of prevalence and outcome from developing countries are not available. This is largely due to the dogma that maternal preexisting seroimmunity virtually eliminates the risk for sequelae. However, recent data demonstrating similar rates of sequelae, especially hearing loss, following primary and nonprimary maternal infection have underscored the importance of congenital CMV infection in resource-poor settings. Although a significant proportion of congenital CMV infections are attributable to maternal primary infection in well-resourced settings, the absence of specific interventions for seronegative mothers and uncertainty about fetal prognosis have discouraged routine maternal antibody screening. Despite these challenges, encouraging results from prototype vaccines have been reported, and the first randomized phase III trials of prenatal interventions and prolonged postnatal antiviral therapy are under way. Successful implementation of strategies to prevent or reduce the burden of congenital CMV infection will require heightened global awareness among clinicians and the general population. In this review, we highlight the global epidemiology of congenital CMV and the implications of growing knowledge in areas of prevention, diagnosis, prognosis, and management for both low (50 to 70%)- and high (>70%)-seroprevalence settings.

Significance of maternal screening for toxoplasmosis, rubella, cytomegalovirus and herpes simplex virus infection in cases of fetal growth restriction

The objective of this study was to evaluate the significance of maternal toxoplasmosis, rubella, cytomegalovirus (CMV) and herpes simplex virus (TORCH) screening in cases of fetal growth restriction (FGR). The medical records of women carrying fetuses with FGR who underwent TORCH screening over a 10-year period were retrospectively reviewed for maternal and congenital TORCH infection. Women carrying fetuses with FGR routinely underwent serologic TORCH tests and systematic ultrasound evaluation for congenital abnormalities. If a congenital CMV infection was suspected, amniotic fluid, placenta or neonatal urine was used for CMV DNA detection by polymerase chain reaction. In 319 patients, no cases of maternal or congenital infection with toxoplasma, rubella, or herpes simplex virus were found. Conversely, six cases (1.8%) were diagnosed with congenital CMV infection, two of which had no structural abnormalities other than FGR. A complete maternal TORCH screening for cases of FGR appears to be unnecessary. Although a maternal CMV test can be considered, the incidence of congenital CMV infection was found to be low in FGR cases.

Central nervous system disorders in infants with congenital cytomegalovirus infection

Background: Congenital cytomegalovirus is the most common cause of congenital infection in developed countries and a major etiology for neurological disability in children. In many countries, there is low awareness of the importance of this virus as a cause of neurological disorders.Methods: We reviewed current knowledge regarding neurological disorders associated to congenital cytomegalovirus infection and analysed the epidemiology of this infection in Latin American countries.Results: The incidence of congenital cytomegalovirus infection reported from Latin American countries ranges from 0 to 6·8% in different settings. Congenital cytomegalovirus infection is a common cause of hearing deficits and mental impairment in children. However, the impact of this infection as a cause of neurological disorders in Latin American countries remains poorly documented.Discussion: Actions are needed to increase knowledge regarding the frequency and impact of congenital cytomegalovirus infection on Latin American children, as well as to increase awareness of the general population and the medical community regarding the need to identify infants infected in utero by this virus and to carefully evaluate their neurological development throughout childhood.

Seroepidemiologic study of human cytomegalovirus in pregnant women in Valiasr Hospital of Kazeroon, Fars, Iran

Background. Cytomegalovirus (CMV) is a common opportunistic infection among HIV-infected individuals, a major source of serious complications among organ-transplant recipients, and a leading cause of hearing loss, vision loss, and mental retardation among congenitally infected children. Women infected for the first time during pregnancy are especially likely to transmit CMV to their fetuses.Objective. In this study, it was aimed to determine the rate of CMV seroprevalence in pregnant women, the prevalence of maternal CMV infection and also the incidence of congenital CMV infection in their newborns in the Kazeroon, south of Iran.Methods. Between January 2007 and July 2007, all (n = 1472) pregnant women who attended the obstetric ward of Valiasr hospital in Kazeroon for delivery, were enrolled in this study, and according to the presence or absence of anti CMV-IgM and CMV-IgG, were classified as seropositive, seronegative and having active maternal CMV infection. Differentiation of primary and recurrent CMV infection in women with both CMV-IgM (+) and CMV-IgG (+) antibody was determined by the avidity index (AI) of anti-CMV IgG.Results. The rate of seropositivity was found as 97.69% and the rate of seronegativity as 2.31% in pregnant women. The prevalence of active maternal CMV infection was found as 4.35% and among these pregnant women, the incidence of primary and recurrent maternal CMV infection was 34.4% and 65.6% respectively.Conclusion. Seroprevalence rate of CMV in pregnant women is high and most infections are recurrent. Thus, it does not seem to be cost-effective to screen all pregnant women for CMV infection, as in the other countries with high seropositivity rate.

Congenital Hearing Loss and CMV Infection

Congenital cytomegalovirus (CMV) infection is associated with sensorineural hearing loss and is the leading nongenetic cause of hearing impairment in infants, but the majority of newborns infected with CMV do not have any clinical signs of CMV disease. To examine the incidence of CMV infection among infants with hearing loss, researchers reviewed the charts of 79,047 infants who were born at one hospital …

Seroprevalencia de la infección por citomegalovirus en puérperas y su impacto neonatal

Cytomegalovirus (CMV) is the most frequent etiologic agent associated with perinatal infections. The incidence of this infection is higher in developing countries. The seroprevalence of CMV infection among pregnant women and its impact on newborns have not been studied in Panama and there are a few publications on this health problem in Latin America. The purpose of this study was to determine the seroprevalence of CMV infection in puerperal women and CMV-related morbidity in the neonates of seropositive mothers. A total of 316 blood samples from puerperal women and 317 urine samples from their newborns were obtained to determine CMV IgG and the polymerase chain reaction CMV test respectively. Risk factors such as parity, socioeconomic status and educational level were analyzed. The seroprevalence of CMV was 84 % and the incidence of congenital CMV infection in the newborns of seropositive women was 0.8 %. Two cases of congenital CMV infection were diagnosed, one of which showed clinical signs at birth, but neither of the newborns showed neurological or audiological sequels in the first 11 months of life. There were no correlations between positive serology and parity, socioeconomic status or educational level in the mothers studied. Although neither of the newborns diagnosed with congenital CMV infection showed clinical signs at the time of this report, we believe that the incidence of 0.8 % found in this study should be kept in mind with a view to evaluating the possibility of including CMV diagnostic tests in neonatal screening and introducing measures to prevent seronegative mothers from becoming infected.

Umbilical cord blood transplantation and cytomegalovirus: posttransplantation infection and donor screening

AbstractThis study assessed the incidence of cytomegalovirus (CMV) infection after transplantation of cord blood (CB) from unrelated donors and evaluated strategies for screening CB donors. Posttransplantation CMV infection, reported in 23% of 1221 CB recipients, was associated with patient pretransplantation CMV serology (P < .001), but not with CMV serology in CB donors or their mothers. A total of 26 988 infant CB donors were evaluated by viral culture of saliva. Subgroups were evaluated by polymerase chain reaction in CB (CB-PCR) in 2 case-control studies. In the first study, 33 of 47 saliva culture–positive CB donors were confirmed by CB-PCR. All mothers of the 33 infants with confirmed CMV infection were CMV–total antibody positive, but only 1 of 3 had CMV-IgM antibody. The second study evaluated infants born to mothers with CMV-IgM antibody. Of these, 5 of 170 saliva culture–negative infants were positive by CB-PCR. The incidence of congenital CMV infection in CB donors was low (0.12%). Maternal serology had poor predictive value for CMV infection in their infant CB donors and bore no detected relationship to CMV infection in CB recipients. Saliva culture for CMV had both false-positive and -negative results. CB-PCR was a useful alternative for detecting CMV in CB donors.

CMV DNA detection in dried blood spots for diagnosing congenital CMV infection in Japan

Human cytomegalovirus (CMV) is a leading congenital infectious agent in developed countries. In the past, the incidence of congenital infection has been rather low in Japan because a high seroprevalence of CMV present in young women. However, this seroprevalence has been decreasing in recent years, so that the incidence of congenital CMV infection in Japanese neonates may increase and approach the level seen in other developed countries. The method was used for detecting CMV DNA reported by Barbi et al. [Barbi et al. (1996): Clin Diagn Virol 6:27-32] using a dried blood spot on filter paper, to diagnose congenital CMV infection in Japanese neonates. This method is effective and less laborious than virus isolation both for epidemiological studies and for identifying asymptomatic infected babies. Japanese neonates (1,176) were examined; two of who were asymptomatic were found to be infected.

168 Asymptomatic Congenital Cytomegalovirus Infection

Background: Cytomegalovirus (CMV) is the most common congenital infection in developed countries with reported incidences varying from 0.15% to 2.0%. Congenital CMV infection may be a cause of a congenital syndrome or run without symptoms. Approximately 90% of congenitally infected infants are asymptomatic at birth but may still present handicaps at a later age. Aims: The objectives of the present study were to evaluate the importance of this agent as cause of morbidity and long term sequelae, and to assess the utility of the different methods of congenital CMV infection screening Methods: Between May and August 2002, 757 consecutive newborns were screened for CMV infection by Polymerase Chain Reaction (PCR) in cord blood and through the isolation of CMV by shell-vial from urine on the first two days of life. Epidemiological characteristics of the mothers and newborn were analysed from medical records. Follow-up was done at 3, 6, 9, 12, 15 and 18 months with neurologic, audiologic, ophthalmologic and development assessments. Results: Asymptomatic congenital CMV infection was diagnosed in 5 out of 757 (0.7%) by means of a virus culture in urine. PCR in cord blood was negative in all cases. In three newborns, within the first 3 weeks of life, the clinical findings included: pneumonia (1); bone marrow failure (1); hepatitis (2); basal ganglia vasculitis (2). At 18 months, follow-up of two infants showed short stature (1), minor abnormal neurodevelopment (1) and partial hearing loss (1). Conclusion: The incidence of congenital CMV infection was similar to that reported in other studies on highly immune populations. Urinary CMV culture is a reliable and convenient method, and may be a screening tool for the detection of congenital CMV infection. Infants with asymptomatic congenital CMV infection may have severe diseases that are not clinically evident at birth. In our series of studies, sequelae were found in 3 out of 5 (60%) children. Funded by Science and Technology Foundation

Congenital cytomegalovirus infection in San Luis Potosi, Mexico.

The incidence of congenital cytomegalovirus infection in Mexico is unknown. We evaluated the presence of cytomegalovirus infection in 560 newborn infants at a public general hospital. There were five (0.89%) infected newborns. Infants with congenital infection were more likely to be born to primigravid mothers (P = 0.01) and were more often from rural areas (P = 0.058) than were noninfected newborns.

Congenital cytomegalovirus infection: review of the epidemiology and outcome.

Cytomegalovirus (CMV) is one of the most common viral causes of congenital infection. A future decision to lower its incidence by vaccination will depend on epidemiological conditions within a country and on the safety of the vaccine to be used, because a life vaccine may cause latency and subsequent reactivation that still may harm the fetus. The aim was to review the epidemiological studies published so far, with respect to factors that affect the incidence of congenital CMV infection, and factors that may influence its outcome, such as preexisting maternal immunity. The study included the data of 19 studies that were retrieved from a MEDLINE search during the period 1977 to 1997. The incidence of congenital CMV infection varied between 0.15% and 2.0% and seemed to correlate with the level of preexisting immunity in the population. Although preexisting maternal immunity was reported to strongly reduce transmission, the severity of congenital CMV infection (symptoms at birth and or sequelae later in life) was not significantly greater after virus transmission due to a primary infection of the mother as compared with recurrence or reinfection. The data indicate that preexisting immunity of the mother does not significantly mitigate the outcome of congenital infection. Moreover, life vaccines may bear a serious risk when transmittable to the fetus. Obstetricians and Gynecologists, Family Physicians. After completion of this article, the reader will be able to describe the natural course of a CMV infection, to list the potential sequelae of a congenital CMV infection, to outline potential strategies to prevent transmission of CMV, and to summarize the diagnostic work up of a patient with a potential CMV infection.

Detection of congenital cytomegalovirus infection in Chinese newborn infants using polymerase chain reaction

Polymerase chain reaction (PCR) amplification was used to detect cytomegalovirus (CMV) in 1000 urine specimens from Chinese newborns for defining the incidence of congenital CMV infection in the Chinese population. The major immediate-early and the late antigen genes of CMV were amplified and detected by gel electrophoresis. There were 18 congenitally infected infants found when tests were performed with one or both primer pairs. Comparing with tissue culture, PCR of both primer sets provided a sensitivity of 94%, a specificity of 100% and a predictive value of positive result of 100%.