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PubMed1993

Serological diagnosis of Mycoplasma pneumoniae infections: a critical review of current procedures.

Respiratory diseases due to Mycoplasma pneumoniae are still confirmed with serological methods, although during the acute phase of M. pneumoniae disease indicative parameters are frequently negative. This result is true not only for serodiagnosis based on tests for the presence of cold hemagglutinin (the first but unspecific acute-phase parameter; these are positive in only about 50% of cases) but also for serodiagnosis based on CF tests, particle agglutination tests, or even enzyme-linked immunoassays that test for "early" IgM antibodies. Whereas the sensitivity of the different tests is difficult to improve, advances in specificity were obtained with use of more defined protein antigen preparations of M. pneumoniae cells. Even more problematic than negative titers in the first serum samples and delayed positive titers in the convalescent-phase sera are false-negative results with sera from immunocompromised patients, which limit the value of serological approaches for diagnosis of M. pneumoniae infections in particular risk groups. This review summarizes the use and the limitations of various serological approaches but also refers to alternative methods that are suitable for diagnosis of acute-phase M. pneumoniae disease or cases in which seroconversion has not occurred.

AIDS-Related Opportunistic Infections↗
PubMed2000

Noninvasive diagnosis of Helicobacter pylori infection in older subjects: comparison of the 13C-urea breath test with serology.

BACKGROUND: The potential influence of cognitive status, physical activities, comorbidity and cotreatments on the feasibility and diagnostic accuracy of two noninvasive diagnostic tests for Helicobacter pylori (Hp) infection, i.e., the 13C-urea breath test (13C-UBT) and serology (immunoglobulin G [IgG] anti-Hp antibodies), in older subjects is not known. METHOD: The study involved 100 consecutive symptomatic elderly subjects (mean age, 78.3 years; range, 65-96 years), who had undergone an upper gastrointestinal endoscopy. Patients were considered Hp positive if at least two of the three invasive methods, i.e. histology, culture, and/or the rapid urease test were positive for Hp infection. Patients were considered Hp negative if all three invasive methods were negative. The 13C-UBT was performed according to the European standard method and the assaying of IgG anti-Hp antibodies by enzyme-linked immunosorbent assay. Cognitive status and functional activities were determined by the Mini-Mental State Examination (MMSE), the activities of daily living (ADLs) and instrumental ADLs (IADLs). RESULTS: According to invasive methods, 49 patients were Hp positive and 47 were Hp negative (4 subjects were excluded from the study). Hp-positive patients demonstrated a significantly higher prevalence of peptic ulcers (p =.02) and activity of chronic gastritis (p<.0001) than Hp-negative subjects. The 13C-UBT demonstrated a sensitivity of 100%, a specificity of 95.7%, and a diagnostic accuracy of 97.9%. Serology had significantly lower sensitivity (74.4%), specificity (59%), and diagnostic accuracy (67%, p<.001) than the 13C-UBT. The feasibility and the diagnostic accuracy of the 13C-UBT were not altered by the cognitive status (MMSE) and functional activities (ADL, IADL) of the patients, their drug consumption, or the prevalence of concomitant diseases. CONCLUSIONS: In older subjects, the 13C-UBT had a significantly higher diagnostic accuracy than serology without influence of cognitive function, disability, comorbidity and cotreatments. This method may be considered an excellent, clinically useful, noninvasive test for the diagnosis of Hp infection in older subjects.

Aged↗
PubMed2005

Serological testing for celiac disease in women undergoing assisted reproduction techniques.

BACKGROUND: The assertion of a causal relationship between celiac disease and infertility is suggested by several lines of research. Nevertheless, robust evidence has not yet been provided. The present study evaluated, for the first time, the prevalence of celiac disease in women undergoing assisted reproduction techniques (ART). METHODS: Serum samples from 200 Italian women undergoing ART were evaluated for celiac disease by endomisium antibody (EMA) and transglutaminase antibody (t-TGA)-two highly sensitive and specific serological markers. Two hundred women not reporting reproductive problems and having delivered at least one child served as controls. In cases of positive serology, the diagnosis was confirmed by jejunal biopsy. RESULTS: Five (2.5%) women from the study group and two (1.0%) from the control group were found to have celiac disease (P = 0.44). The main indications for ART in women found to have celiac disease were tubal factor in two cases and male infertility in three cases. None of these women reported major gastrointestinal complaints. Extra intestinal signs linked to celiac disease were noted in four out of five patients. CONCLUSION: This study raises the issue of celiac disease screening in ART programmes. Given the available evidence in the literature combined with our observations from this study, the value of serological testing for celiac disease in infertile women remains uncertain. Further studies to address this issue are required.

Adult↗
PubMed1974

Serologically active glycolipid families from Mycobacterium bovis BCG. I. Extraction, purification and immunologic studies.

Glycolipids were extracted from mycobacteria with methanol and chloroform and purified by silicic acid chromatography. These glycolipids were studied for their serologic activity by direct and indirect (Coomb's) passive hemagglutination, and by inhibition methods. Three families of serologically active glycolipids called A, B and C, plus cardiolipin, were isolated. The B and C families of glycolipids were reactive with sera from BCG immunized rabbits and also with sera from patients with tuberculosis and leprosy; the A family was reactive only with the human sera. None of the serologically active glycolipids was able to protect rabbits against tuberculosis.

Animals↗
PubMed1998

Microbiological and serological diagnostic tests for Helicobacter pylori: an overview.

Different invasive and non-invasive diagnostic tests are available for the diagnosis of H. pylori in the individual patient. In practice, endoscopic tests are best for a primary diagnosis of H. pylori infection because endoscopy allows assessment of treatment indications. The new rapid urease tests may help the clinician in treatment decision-making. Culture is currently not recommended for routine evaluation, but it is becoming increasingly important in certain populations with higher prevalence of drug resistance, since it allows testing for susceptibility to antibiotics. Serological testing has been recommended for initial pre-endoscopy or pre-treatment screening in dyspeptic patients. However, several current 'in-office' tests appear insufficiently accurate or would need further validation before being recommended for use in clinical management strategies at a primary care level. The urea breath tests are best suited to confirm eradication early after treatment, while laboratory serology tests are of limited use, since 6 months are required before a result can be obtained. The serological office tests cannot be used for post-treatment assessment of H. pylori status.

Bacteriological Techniques↗
PubMed1980

Forensic serology in the United States. I. Blood grouping and blood transfusion--Historical aspects.

The events of three periods occurring during 1900-1980 are traced to illustrate the sources from which forensic serology evolved. The growth of blood grouping and blood transfusion, especially during the periods of military exigency, comprise the basic structure of forensic serology. Chaotic serologic procedures and confusing A-B-O terminology presented multiple challenges to workers in the field, including hospital transfusion services. The 1940s saw a beginning of standardization achieved through a combination of training, research and recommendations of the National Research Council to the Armed Services.

ABO Blood-Group System↗
PubMed1998

Serologic testing of cornea donors.

PURPOSE: To review the current requirements and rationale for serologic testing of cornea donors and to provide guidelines for dealing with results of nonrequired tests. METHODS: Eye Bank Association of America (EBAA) and Food and Drug Administration (FDA) regulations are examined with respect to current knowledge of the risk of donor-to-host transmission of systemic infectious diseases via corneal transplantation. RESULTS: Negative screening tests are required for human immunodeficiency virus (HIV) 1 and 2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) before release of tissue for transplantation. Other tests reported by organ-procurement organizations commonly include hepatitis B core antibody (anti-HBc), syphilis, cytomegalovirus (CMV), and human T-lymphotropic virus (HTLV) I and II. No systemic infectious-disease transmission from donor corneas supplied by EBAA-member eye banks has occurred in the last 12 years, a period during which >400,000 corneas were provided for transplantation. CONCLUSION: EBAA donor-screening requirements, including serologic testing, have resulted in an excellent safety record. Requirements for serologic testing should continue to be regularly reviewed as new information becomes available.

Corneal Transplantation↗
PubMed1999

Evaluation of serology, 13C-urea breath test, and polymerase chain reaction of stool samples to detect Helicobacter pylori in Bangladeshi children.

BACKGROUND: Serologic methods to detect Helicobacter pylori in infants, especially in developing countries, may be limited because of decreased immune response caused by malnutrition. The true prevalence may therefore be underestimated in this age group. Urea breath test is considered to be a good screening method in children but is expensive and therefore is not suitable for screening in developing countries. Simple, inexpensive, and accurate noninvasive methods to detect H. pylori in infants and young children are needed. METHODS: Enzyme immunoassay (EIA) and immunoblot (IB) serologic analyses, 13C-urea breath test (UBT), and immunomagnetic separation--polymerase chain reaction (IMS-PCR) were performed on stool specimens, to detect H. pylori in 68 children between 4 and 24 months of age (mean, 11.5 months) in an endemic area in Bangladesh and the results compared. RESULTS: The occurrence of H. pylori was 57% (n=39) using only UBT, 60% (n=41) using only IMS-PCR, and 78% (n=53) using UBT and IMS-PCR together. The concordance between UBT and IMS-PCR results was 62%. Immunoblot was positive in only 9% (n=6). Results in all 68 children were negative using EIA. DISCUSSION: The prevalence of H. pylori infection in this periurban community and age group was high. Only serologic methods seem to be unsatisfactory for screening of H. pylori infection in infants and may not reflect the true prevalence. Immunomagnetic separation-PCR is a simple and rapid method for detection of H. pylori in stool and is an attractive method for analysis of colonization in infants. However, it may reflect a different stage of disease than UBT. Further studies are needed to clarify this.

Antibodies, Bacterial↗
PubMed1998

Can serology diagnose upper genital tract Chlamydia trachomatis infections? Studies on women with pelvic pain, with or without chlamydial plasmid DNA in endometrial biopsy tissue.

BACKGROUND: Upper genital tract chlamydial infections in women are on the increase, and serology might be a convenient tool for diagnosis. Evaluations of this approach are needed in women with or without microbiologic evidence of organisms in the upper genital tract. GOALS: To compare the results of antibody assays with cervical culture and upper genital tract histopathology in women with pelvic pain and chlamydial plasmid DNA in endometrial biopsies. STUDY DESIGN: Chlamydia trachomatis plasmid DNA was detected by polymerase chain reaction (PCR) on extracted deparaffinized endometrial biopsy tissue. Five antichlamydial antibody assays were performed measuring total antibodies or immunoglobulin G (IgG), IgM, and IgA classes on sera from 14 women with plasmid DNA as well as 31 without plasmid DNA. RESULTS: Accepting the presence of plasmid DNA as the gold standard, no single test had total diagnostic accuracy. The best sensitivity and specificity occurred with the following assays: whole inclusion fluorescence (WIF) (100% and 80.6%); microimmunofluorescence IgM (MIF IgM) (78.6% and 93.6%); and heatshock protein-60 enzyme immunoassay (42.9% and 100%). Although recombinant anti-lipopolysaccharide enzyme-linked immunosorbent assays measured anti-chlamydial antibodies in a large proportion of these women, specificity was low. The sensitivity and specificity of cervical culture was 28.6% and 100% and of endometrial histopathology was 71.4% and 48.4%. Analysis of patient serological profiles suggested that and 6 women without plasmid DNA may have been cases that were missed by PCR. CONCLUSIONS: Evaluations of assays to diagnosis Chlamydia trachomatis upper genital tract infections could use the presence of organisms or their markers in the upper genital tract as a standard of comparison. Some of these serological assays, such as WIF or MIF IgM, may be helpful in diagnosis, but more studies are needed.

Antibodies, Bacterial↗
PubMed1994

Serologic diagnosis of viral hepatitis.

Recent advances have made available to the clinician multiple serologic tests for the diagnosis and evaluation of acute and chronic viral hepatitis. While the multiplicity of tests available can be confusing, selective use of these serologic tests tailored to the clinical situation can be of great value in identifying the agent causing the liver disease. I present a clinically oriented discussion of the serologic tests available to diagnose viral hepatitis.

Acute Disease↗
PubMed1999

A comparison of two rapid whole-blood tests and laboratory serology, in the diagnosis of Helicobacter pylori infection.

OBJECTIVE: To compare two rapid whole-blood serology tests for Helicobacter pylori and a laboratory serology assay against a gold standard. DESIGN: Prospective comparison of tests in 81 patients. SETTING: A hospital rapid access endoscopy clinic. PARTICIPANTS: Dyspeptic patients requiring assessment of H. pylori status. INTERVENTIONS: Measurement of H. pylori antibody status by Quickvue One-step, Helisal, and Premier H. pylori test; 13C urea breath test for H. pylori, and gastric biopsies for histology, culture and rapid urease test. MAIN OUTCOME MEASURE: Sensitivity and specificity of Quickvue One-step, Helisal and Premier tests, compared to a gold standard based on 13C urea breath test, biopsy culture, histology and urease test. RESULTS: The Quickvue assay has significantly greater sensitivity (81%) than Helisal (67%), but without appreciable loss of specificity (86% and 93%, respectively). The Premier laboratory assay is significantly more sensitive than both of the rapid blood tests (96%), with comparable specificity to the Quickvue assay. CONCLUSION: The rapid serology tests used in this study are quick and convenient to use, but do not approach the sensitivity of a laboratory assay in detecting H. pylori status in this group of dyspeptic patients attending an endoscopy clinic.

Adolescent↗
PubMed2000

Evaluation of a commercial serological kit for detection of salivary immunoglobulin G to Helicobacter pylori: a multicentre study.

OBJECTIVE: To evaluate the usefulness of a commercial serological enzyme immunoassay (EIA) for detecting salivary immunoglobulin (Ig) G to Helicobacter pylori. DESIGN: Prospective, multicentre study. SETTING: The study was conducted at 11 gastroenterology hospital centres throughout Italy. PARTICIPANTS AND INTERVENTIONS: Two hundred and thirteen dyspeptic patients underwent gastroscopy with antral biopsies. At each centre, two of the following three tests for H. pylori diagnosis were performed: urease quick test, histology, and 13C-urea breath test. Samples of unstimulated saliva and venous blood were collected from each patient. Salivary and serum H. pylori IgG were determined with the EIA Helori-test IgG (Eurospital, Trieste, Italy). MAIN OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive values, and accuracy of the salivary and serum EIAs. RESULTS: By using a receiver operating characteristic curve, salivary EIA yielded 81% (95% confidence interval 73-87%) sensitivity, 73% (62-83%) specificity, 84% (76-90%) positive predictive value, 69% (58-79%) negative predictive value, and 78% (72-84%) accuracy. At the cut-off suggested by the manufacturer, serum EIA had 90% (84-95%) sensitivity, 78% (67-86%) specificity, 88% (81-93%) positive predictive value, 82% (71-90%) negative predictive value, and 86% (81-91%) accuracy. CONCLUSION: In this large multicentre study, detection of salivary H. pylori IgG with a commercial serological EIA was a fairly accurate diagnostic method. Data confirm that saliva testing does not compare favourably with serology in the assessment of H. pylori status.

Adolescent↗
PubMed2005

The diagnostic accuracy of serologic markers in children with IBD: the West Virginia experience.

GOAL: To assess the sensitivity/specificity of the serologic markers: perinuclear antineutrophil cytoplasmic antibody (pANCA) and anti-saccharomyces cerevisiae antibody (ASCA) in children diagnosed with inflammatory bowel disease (IBD), living in West Virginia. BACKGROUND: In recent years, serologic markers have been used to differentiate between CD and UC diseases in children. The clinical usefulness of these markers in children was restricted by their low sensitivity and specificity. Racial and ethnic diversity may alter the accuracy of these markers in children. The demographic homogeneity of the West Virginia population may offer a better clinical setup to reassess the utility of those markers in children with IBD. STUDY: A retrospective analysis of all the charts of children diagnosed with IBD was performed at the gastroenterology clinics of Marshall University, Huntington, WV; and West Virginia University, Charleston Division, Charleston, WV. The diagnosis of IBD was established according to clinical, radiologic, and endoscopic data. Laboratory data and serum markers were recorded, and their accuracy to diagnose UC or CD was assessed. RESULTS: A total of 101 charts were reviewed, of which only 90 (89%) included serologic markers and were considered for further analysis. Disease distribution included: UC-41, CD-44, and indeterminate colitis (IC)-7 (2 patients changed diagnosis after colectomy). Serum antibody pANCA had a sensitivity of 73% and specificity of 84% for UC, but only 16% and 35% for CD, respectively. Serum antibody ASCA had a sensitivity of 58% and specificity of 92% for CD, but only 7% and 49% for UC, respectively. The outer membrane porin to Escherichia coli antibody (anti-OmpC) was available in 54 (59%) children and demonstrated a very poor sensitivity for both diseases (sensitivity<11%). CONCLUSION: Despite our homogeneous patient population, pANCA and ASCA antibodies had an inadequate sensitivity/specificity for children with UC or CD. Those antibodies were not useful for our small number of patients with IC.

Adolescent↗
PubMed2003

Is human herpesvirus 6 linked to kikuchi-fujimoto disease? The importance of consistent molecular and serologic analysis.

BACKGROUND: Kikuchi-Fujimoto disease, also called histiocytic necrotizing lymphadenitis, is a self-limiting lymphadenopathy of unknown cause. The patient often presents with fever, malaise, and lymphadenopathy primarily involving the cervical lymph nodes. Laboratory findings are nonspecific, and the diagnosis is established by identifying characteristic pathologic features from lymph node biopsy. The etiologic agent has been proposed to be of viral origin; specifically, human herpesvirus 6 (HHV-6) has been implicated. METHODS: The clinical, histologic, serologic, and molecular data from 471 cases of Kikuchi-Fujimoto disease reported between 1982 and 2001 and their relationship to HHV-6 were reviewed. RESULTS: Thirty-two of the 471 patients in this review were tested for HHV-6 serology; all 32 had elevated titers for HHV-6. One hundred twelve patients with lymphadenopathies, including histiocytic necrotizing lymphadenitis, tested positive for HHV-6 by polymerase chain reaction. In situ hybridization results were positive in 41 cases. CONCLUSION: This review illustrates the necessity for consistent molecular and serologic analysis.

Adult↗
PubMed2005

Reactive Lyme serology in optic neuritis.

BACKGROUND: Establishing a causal relationship between optic neuritis and Lyme disease (LD) has been hampered by technical limitations in serologic diagnosis of LD. Even so, there is a general impression that optic neuritis is a common manifestation of LD. METHODS: Retrospective case analysis of Lyme serology in 440 patients with optic neuritis examined between 1993 and 2003 in a single neuro-ophthalmic practice at Stony Brook University Medical Center, Suffolk County, New York, a region hyper-endemic for LD. RESULTS: Lyme enzyme-linked immunosorbent assay (ELISA) was positive in 28 (6.4%) patients with optic neuritis, three of whom had syphilis with cross-reactive antibodies. Among the remaining 25 ELISA-positive patients, optic neuritis could be confidently attributed to LD in only one case, a patient with papillitis. The other 24 cases had reactive Lyme serologies related to a history of LD years earlier, asymptomatic exposure, false-positive results, or non-specific humoral expansion. The ELISA in these 24 cases were weakly positive and the Western blots were negative by Centers for Disease Control criteria. There were no significant clinical differences between the 25 seropositive optic neuritis cases and 50 seronegative optic neuritis cases. CONCLUSIONS: Based on these cases and a review of the literature, there is insufficient evidence for a causal link between LD and retrobulbar optic neuritis or neuroretinitis. There is sufficient evidence to establish a causal link between LD and papillitis and posterior uveitis.

Adolescent↗
PubMed2004

Laboratory diagnosis of pertussis infections: the role of PCR and serology.

This study reports on practical laboratory aspects of pertussis diagnosis. PCR assays were applied to respiratory specimens obtained during a large study of infants (less than 5 months old) admitted to paediatric intensive care units (n = 122), children (less than 15 years old) admitted to paediatric wards (n = 16) and their household contacts (n = 320). Estimation of antibodies to pertussis toxin and culture for Bordetella pertussis were attempted on specimens from the same patients, where available, and the overall utility of the diagnostic PCR assays was assessed by comparison to these results. A PCR assay for the human mitochondrial cytochrome oxidase (HMCO) gene was used for quality control of the extracted samples and an internal process control (IPC) was included in each sample to test for PCR inhibition. Four of 458 samples were considered unsuitable (three HMCO negative, one IPC negative) and excluded from further analyses. Positive PCR results were considered valid if they were either (i) positive for both of two B. pertussis gene targets (pertussis toxin S1 promoter and the insertion element IS481), i.e. consensus PCR positive, or (ii) repeatably positive in only one assay. Using these criteria, 52 of 454 (11.5 %) samples were considered as PCR positive for B. pertussis. Six of 356 samples were culture-positive for B. pertussis, 1/88 infants, 3/14 children and 2/254 contacts, giving an overall isolation rate of 1.7 %. Using these data, PCR gave an almost fivefold increase in diagnostic yield compared with culture (McNemar's test; P < 0.0001). Sera from 9/111 infants, 5/10 children and 14/210 contacts were positive. Serology and PCR results showed a high level of agreement (113/121) for infants and children. PCR demonstrated a significant improvement in diagnostic yield over culture. Serological testing also resulted in a significant increase in diagnostic yield compared to culture alone. PCR is a useful technique, but validity of results must be assured by careful control. Rapid diagnosis of B. pertussis infection particularly in infants by PCR, together with serological assays, can enhance surveillance systems for pertussis in all age groups.

Adolescent↗
PubMed2005

Heparin-based ELISA reduces background reactivity in virus-like particle-based papillomavirus serology.

The interaction between human papillomavirus (HPV) particles and cell surface heparan sulfate requires intact conformation of the HPV particles. Type-specific HPV serology is currently based on virus-like particles (VLPs) with intact conformation. Presence of incorrectly folded VLPs in VLP preparations is recognized as an important cause of cross-reactivity in HPV serology. Heparin-coated microtitre plates were evaluated for capturing conformationally correct VLPs and improving the type specificity of HPV serology. Hybrid VLPs between HPV16 and HPV11, which had been found to have significant reactivity with children's sera and a batch of HPV18 VLPs that had failed the quality control because of significant reactivity with sera from virginal women, were tested in parallel with heparin ELISA, ordinary ELISA and type-specific mAb capture ELISA. Control sera from children that had detectable reactivity with HPV16/11 hybrid VLPs in ordinary ELISA did not react in heparin-based ELISA, but some hybrid VLPs also had background reactivity in capture ELISAs. Control sera from virginal women that had some reactivity with a poor quality HPV18 VLP preparation in ordinary ELISA had no reactivity in heparin or capture ELISA, suggesting that certain VLP preparations expose cross-reactive epitopes that are not exposed on VLPs with heparin-binding ability. As the sensitivity was similar or only marginally affected by the use of heparin plates, use of heparin-coated plates may improve the type specificity of VLP-based ELISAs and reduce interassay variability attributable to variable quality of different VLP batches.

Adolescent↗
PubMed1993

The validity of injecting drug users' self-reports about sexually transmitted diseases: a comparison of survey and serological data.

Researchers studying the validity of injecting drug users' self-reports have often reported a high degree of correspondence between self-reports and several types of criterion variables. In this study, injecting drug users' responses to questions about prior infection with four sexually transmitted diseases were compared with serological test data. For three of the four diseases studied, discrepancies between survey and serological results were quite large, especially when respondents said they had no previous history of infection. Limitations of serological testing, the questions asked, respondent knowledge and the more traditional concern with respondent veracity are discussed as possible explanations for the observed differences. Study data suggest that use of drug injectors' self-reports to measure infection with sexually transmitted diseases or to validate other measures is a questionable practice. Problems encountered in interpreting study results provide support for more frequent use of experimental or quasi-experimental designs and of multivariate analytic techniques when conducting research on response validity.

Adult↗