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PubMed2004

Chagas cardiomyopathy and serologic testing in a small rural hospital in Chiapas, Mexico.

OBJECTIVES: To conduct a study in a small rural hospital located in the state of Chiapas, Mexico, to: (1) examine the prevalence of chagasic cardiomyopathy among patients with the diagnosis of congestive heart failure and (2) assess the prevalence of positive serologic results in blood donors in the hospital, in an attempt to ascertain whether Chagas' disease remains an important cause of heart failure at least in some areas of Mexico. METHODS: The study of patients with cardiomyopathy was conducted by retrospective chart review of patients with the diagnosis of congestive heart failure treated at the hospital during the years 2000-2002. With the blood donors, the results of their serologic screening were reviewed for a six-month period beginning in April 2002. Serologic testing was done in both groups with either indirect hemagglutination (IHA) or enzyme-linked immunosorbent assay (ELISA), or with both. RESULTS: Of 67 patients with heart failure and no risk factors for other causes of heart failure, 40 of them had serologic tests performed. Thirty-three of these 40 (82.5%) were positive by ELISA, IHA, or both. With 97 blood donors, one or both serologic tests were positive in 17 of them (17.5%). CONCLUSIONS: This research adds to the evidence that Chagas' disease continues to be a major cause of heart failure in some areas of Mexico and that there continues to be a risk of transmission by blood transfusion if donated blood is not consistently screened.

Adult↗
PubMed1995

Evaluation of different serological tests for detection of antibodies against Serpulina hyodysenteriae in pig sera.

Swine dysentery is a mucohemorrhagic diarrheal disease caused by S. hyodysenteriae. The detection of asymptomatic carriers in herds is possible by serological tests. However, cross-reactions between S. hyodysenteriae and S. innocens pose a major problem in serological diagnosis. Several serological tests were evaluated for detection of antibodies to S. hyodysenteriae such as: indirect hemagglutination, passive hemolysis, conglutination and microagglutination tests. Among the tests used, only the microagglutination test was able to detect antibodies to S. hyodysenteriae. 70 to 95% of the pigs were invariably seropositive in a single dilution of 1:10 in actively infected herds whereas the number of seropositives did not exceed 10% in presumably non-infected herds. The test was found to be simple, and reliable to be used with confidence for detection of herd infection using boiled cell suspension as an antigen.

Animals↗
PubMed1991

Spurious serologic test results in patients receiving infusions of intravenous immune gammaglobulin.

Intravenous immune gammaglobulin (IVIgG) has a definite role in the modern armamentarium of therapies for immunocompromised patients. Intravenous IgG is manufactured from the plasma of a large number of donors and contains antibodies against numerous infectious agents. Patients who receive infusions of IVIgG may test false-positive for a variety of viral, bacterial, and other infectious diseases when serologic determinations are performed on their blood samples. It is important that laboratories performing serologic testing be aware that patients have been infused with IVIgG, so that spurious laboratory results can be identified. Serologic testing on implicated lots of IVIgG and on the patient's pretreatment sample may aid in correctly identifying a spurious serologic result due to therapy with IVIgG.

Adolescent↗
PubMed1989

A sensitive and specific serologic test for detection of Campylobacter pylori infection.

Campylobacter pylori has been associated with gastritis, duodenal ulcer, gastric ulcer, and nonulcer dyspepsia. Evidence that C. pylori may be the causative agent or at least a major contributory factor in peptic ulcer disease has generated intense interest in the development of reliable methods for detecting C. pylori infections. We have developed a specific and sensitive enzyme-linked immunosorbent assay (ELISA) that detects serum immunoglobulin G antibodies directed against high molecular weight cell-associated proteins (HM-CAP) of C. pylori. In a blinded fashion we tested sera from 300 individuals and found that all of 147 HM-CAP ELISA-negative individuals were also negative for C. pylori, as documented by a negative urea breath test; also, 151 of 153 C. pylori-positive (by urea breath test) individuals were HM-CAP ELISA-positive. Campylobacter pylori was cultured from the two ELISA-negative but infected patients and these isolates did possess HM-CAP antigens, showing that these two individuals had failed to seroconvert. Thus, the specificity and positive predictive value of the HM-CAP ELISA were each 100%; the sensitivity of the assay was 98.7%, and the negative predictive value was 98.6%. The HM-CAP ELISA and the urea breath test both proved valuable for detecting C. pylori infection, the urea breath test being a more direct method whereas the ELISA is less expensive and easier to perform. Furthermore, the results of a serologic test such as the HM-CAP ELISA would not be influenced by recent ingestion of bismuth compounds or antimicrobial therapy, which might suppress C. pylori and cause a transient false-negative result in the urea breath test.

Adult↗
PubMed2003

Laboratory-based diagnosis of brucellosis--a review of the literature. Part II: serological tests for brucellosis.

Brucellosis is a common zoonotic disease transmittable to humans from infected animal reservoirs. Malta, Rock, Gibraltar, Cyprus or Mediterranean fever, Bang's disease, intermittent typhoid or typho-malarial fever, undulant fever, etc. are just various synonyms for brucellosis. Patients suffering from this disease show unspecific symptoms, e.g. fever, chills, malaise, arthralgia, headache, tiredness and weakness. Human brucellosis may be caused by four of totally six genetically and phenotypically closely related Brucella species, i.e. B. melitensis, B. abortus, B. suis and B. canis. Although many organ systems may be involved, brucellosis is rarely fatal. Therapeutic failure and relapses, chronic courses and severe complications like bone and joint involvement, neurobrucellosis and endocarditis are characteristic for the disease. A definite diagnosis requires the isolation of Brucellae from blood, bone marrow or other tissues. However, cultural examinations are time-consuming, hazardous and not sensitive. Thus, clinicians often rely on the indirect proof of infection. The detection of high or rising titers of specific antibodies in the serum allows a tentative diagnosis. A variety of serological tests has been applied, but at least two serological tests have to be combined to avoid false negative results. Usually, the serum agglutination test is used for a first screening and complement fixation or Coombs' test will confirm its results. As Brucella ELISAs are more sensitive and specific than other serological tests, they may replace them step by step. This review will summarize advantages and disadvantages of the serological techniques used in clinical laboratories for indirect verification of human brucellosis.

Agglutination Tests↗
PubMed1985

AIDS serology testing in low- and high-risk groups.

The performance characteristics of the acquired immunodeficiency syndrome (AIDS)-retrovirus serological tests including enzyme-linked immunosorbent assay (ELISA), Western blot, and immunofluorescence assay were defined in a clinical laboratory setting by testing 1,257 serum specimens from low- and high-risk groups for AIDS. The three prototype AIDS retroviruses (lymphadenopathy-associated virus, human T-lymphotropic virus III, and AIDS-associated retrovirus) were equally suitable as target antigen for these assays. Sera from six of 74 laboratory and health care personnel and 91 of 1,014 unselected blood donors were falsely positive by ELISA (positive to negative ratio [P/N], greater than or equal to 2) based on the lack of Western blot confirmation. Only two true-positives (two [0.2%] of 1,014 blood donors) were detected in these low-risk groups. In contrast, 106 of 108 specimens with ELISA P/N ratios of 2 or greater from the high-risk groups including asymptomatic homosexual men, hemophiliacs, AIDS-related complex patients, and AIDS patients were positive by Western blot and immunofluorescence assay. Four false-negative ELISA results based on positive immunofluorescence assay and Western blot were found in the AIDS patient group. Ten of 69 AIDS patients were negative by all three serological tests. The consequence of maintaining high sensitivity for the ELISA (P/N ratio, greater than or equal to 2) as a screening test was a loss of specificity. The number of false-positive results necessitated the use of a confirmation test with greater specificity.

Acquired Immunodeficiency Syndrome↗
PubMed1985

Internal quality control in serological tests for syphilis.

The importance of syphilis serological tests demands that laboratory reports are reliable. Internal quality control applied to the organisation of a syphilis serology service improves laboratory bench performance and reporting. Described here are internal quality control procedures of a department that serves a genitourinary medicine clinic and conducts 70 000 tests a year to investigate for syphilis.

Fluorescent Antibody Technique↗
PubMed2000

The incidence of hepatitis C virus positive serological test results among cornea donors.

Purpose. We have noticed that the incidence of positive serological tests of hepatitis C virus (HCV) among cornea donors in our eye bank is higher than expected. The purpose of this study was to determine the incidence of these positive findings and identify the contributory risk factors.Methods. All corneas procured between June 1993 and June 1997 were included in this retrospective study. In all cases a routine work-up, including serological testing of donors' sera and evaluation of the procured corneas, was performed prior to corneal transplantation. Donors found to be positive for HCV antibodies were compared to our general population of corneal donors, with respect to the demographic, serological and ophthalmological data obtained during the transplantation work-up.Results. All 851 corneas procured from 438 donors were included. Antibodies to HCV were found in 29 donors (6.6%). Following positive test results, 57 corneas (6.7%) were discarded. The time from donors' death to cornea procurement was significantly longer among HCV-positive patients than in the general donor population (12.3 vs. 9.3 h, p<0.0003). No other differences were detected between the two groups.Conclusion. Delay in harvesting of donated corneas may give rise to false positive HCV-antibodies test results, which may be partially responsible for the high rate of positive findings among cornea donors, with consequent tissue wastage.

Journal Article↗
PubMed1996

When viral serological testing is not enough: diagnosing disease in vaccinated animals.

Serological testing can be a key factor in diagnosing viral diseases. However, the extensive use of vaccines in companion animals can severely limit the use antibody detection testing. Modified-live vaccines induce an immune response that is indistinguishable from street virus in the antibody pattern and time course. Alternative testing schemes may be needed to assist the practitioner in arriving at a valid diagnosis.

Animals↗
PubMed1987

Comparison of TRACK XI fluorometric immunoassay system with other serologic tests for detection of serum antibody to Brucella abortus in cattle.

The TRACK XI system (TRACK) is a commercially available fluorometric immunoassay system that has been adapted for the detection of antibodies to several antigens in various animal species. Serum antibodies to Brucella abortus were detected by TRACK and compared with those obtained from two primary binding assays (a fluorometric immunoassay [FIAX] and an enzyme-linked immunosorbent assay) and three standard serological tests (complement fixation, Rivanol precipitation, and CARD tests). A total of 298 serum samples were tested by each serological test. Of these serum samples, 134 were negative controls, 43 were from cattle 1 month after vaccination with B. abortus 19, and 121 were from cattle 10 to 12 weeks after a midgestational, intraconjunctival challenge with B. abortus 2308. The results of this study indicated that TRACK is both reproducible and accurate. The results compared favorably with those of other serological methods. TRACK is more rapid than either the enzyme-linked immunosorbent assay or FIAX system. TRACK was the most sensitive (96.3%) test, with a specificity of 100%.

Animals↗
PubMed2002

[Serological testing and prevalence of human immunodeficiency, hepatitis B and C viruses infections amongst acute psychiatric inpatients].

BACKGROUND AND OBJECTIVE: The request for serological tests for HIV, HBV and HCV is usual amongst acute psychiatric inpatients. Nevertheless, the seroprevalence and the repercussion of a positive result have been scarcely studied. PATIENTS AND METHOD: Serological requests for these viruses were retrospectively analyzed in a sample of 332 psychiatric inpatients. RESULTS: Serological tests were requested by 65.3% patients. The prevalence of any seropositivity was 7.3%: 1.4% were infected by HIV-I, 3.2% had been in contact with HBV but none had an active infection, and 5.1% were infected by HCV. The presence of a positive result did not change the psychiatric therapeutic approach in any case. CONCLUSIONS: The low prevalence of seropositivity suggests that such tests should be performed selectively in patients who present risk factors or atypical psychiatric symptoms.

Acute Disease↗
PubMed1980

Routine Serologic Testing for Syphilis in a Community Medical Practice.

A retrospective review of 8,100 serologic tests for syphilis ordered during a 42-month period yielded positive rapid plasma reagin test results in 127 patients (1.6 percent) and a positive fluorescent treponemal antibody absorption reaction in 91 patients (1.1 percent). Of the 36 cases of biologic false-positive reactions, most were in prenatal patients. Forty-six cases of syphilis were previously undiagnosed but antibiotic therapy was given in only 26 of the patients. Some 24 percent of syphilitic patients were not treated because the positive serologic findings were overlooked. Cerebrospinal fluid determinations were analyzed and cost-effectiveness of finding a single case of previously undiagnosed syphilis was calculated. We found that routine serologic tests and cerebrospinal fluid studies for syphilis in asymptomatic patients had low rates of positivity in our community hospital and outpatient practice.

Costs and Cost Analysis↗
PubMed1996

Comparison of rapid serological tests (FlexSure HP and QuickVue) with conventional ELISA for detection of Helicobacter pylori infection.

BACKGROUND: There is a need for accurate and rapid tests for Helicobacter pylori infection especially since the recent National Institutes of Health Consensus Development Conference on H. pylori in peptic ulcer disease charged the medical community with treating H. pylori infection in all patients with H. pylori and ulcer disease. METHODS: We prospectively compared a simple, rapid serological test (FlexSure HP, SmithKline Diagnostics) for the detection of serum IgG antibodies against H. pylori with another rapid test (QuickVue, Quidel) and two enzyme immunoassays (HM-CAP, Enteric Products, and PyloriStat, BioWhittaker). Serum samples from 551 individuals including both symptomatic patients (196) and asymptomatic volunteers (355) were tested for the presence of IgG antibodies against H. pylori. The presence or absence of active H. pylori infections was determined using the [13C]-urea breath test. RESULTS: All of the serological tests performed well. FlexSure HP had calculated sensitivity, specificity, and accuracy of 94.4, 87.6, and 91.1%, respectively, relative to the urea breath test. In 49 of the 551 samples, the urea breath test and FlexSure HP did not agree. Those samples were tested with HM-CAP immunoassay to confirm presence or absence of IgG antibodies against H. pylori. After the resolution of the discordant results, the sensitivity, specificity, and accuracy of FlexSure HP were 96.0, 95.1, and 95.6%, respectively, and were comparable to HM-CAP and PyloriStat. FlexSure HP was compared with histology or culture in 75 cases, and the accuracy was 100%. FlexSure HP and QuickVue were compared using 200 serum samples. FlexSure HP was more specific (88.7 vs 79.4%) and accurate (91 vs 84%) than QuickVue (p < 0.05 for both), relative to the urea breath test with discordant samples unresolved. FlexSure HP was also simpler to use, easier to interpret, and faster than QuickVue. FlexSure HP required no sample dilution, one reagent, four steps, and 5 min to complete. CONCLUSION: FlexSure HP is an excellent option for in-office tests for the physician who desires immediate results or for small laboratories that do not have the volume of H. pylori testing to justify ELISA test formats.

Adolescent↗
PubMedDate not supplied

National survey to determine uniformity of serological test results for avian mycoplasmosis.

A national survey was conducted to address the concern over the uniformity of serological test results for avian mycoplasmosis. The National Veterinary Services Laboratories produced chicken and turkey mycoplasma serum-check test kits. Each kit had a total of 25 sera that consisted of negative and positive sera. Participating laboratories were requested to examine their kits using the serum plate agglutination test with the plate antigens currently being used and the hemagglutination inhibition test with the hemagglutinating antigens provided. A conclusion whether serum plate agglutination-positive sera were positive, negative, or suspicious was based on the hemagglutination inhibition test results. Results in each category were scored on the basis of 100 points. The average scores on the serum plate agglutination test, hemagglutination inhibition test, and conclusion were 95, 71, and 91, respectively, for the chicken serum test kit and 91, 71, and 89, respectively, for the turkey serum test kit. The results indicated a high degree of uniformity among laboratories in reporting serological test results for mycoplasmosis in chickens and turkeys.

Animals↗
PubMed1991

[Development of a serological test for tuberculosis].

Antigens secreted by M. tuberculosis in the culture medium and antigens obtained from sonicated M. tuberculosis were characterized, at the laboratory of Tropical Hygiene of the Royal Tropical Institute and the division of Pulmonary Medicine at the Academic Medical Centre, in order to explore which antigens could be valuable in the development of a serological test for tuberculosis. Using murine monoclonal antibodies in immunoblot, a pattern of protein bands distinct from that of the corresponding M. tuberculosis sonicate was found in the culture medium. The major protein bands of the culture medium, of 24 and 12 kD, and the major protein band of 16 kD in sonicate were purified. These antigens were tested in ELISA with sera from 20 patients with tuberculosis, diagnosed by a positive culture of M. tuberculosis, and from 21 control subjects. The ELISA results obtained with these 3 antigens were combined and the mean value obtained in the control group plus 2 times the standard deviation was chosen as the cut-off level. Sixteen of the 20 patients with tuberculosis had antibodies against 1 of the purified antigens, while none of the control subjects had. By combining the results, obtained with these 3 antigens, 17 of the 20 patients with tuberculosis were positive in this serological test and none of the control subjects. The 24, 12 and 16 kD antigens may be valuable for the development of a serological test for tuberculosis.

Antigens, Bacterial↗
PubMed1996

Qualitative evaluation of the Canadian Medical Association's counselling guidelines for HIV serologic testing.

OBJECTIVE: To evaluate the face and content validity of the CMA's counselling guidelines for HIV serologic testing in order to prepare a revised edition. DESIGN: Qualitative evaluation by structured focus groups in September and October 1994 to assess the relevance, clarity and practicality of the guidelines, followed by content analysis of the discussions. SETTING: Vancouver, Winnipeg, Toronto, Montreal, Quebec City and St. John's. PARTICIPANTS: Primary care physicians randomly selected from the CMA database and nonrandomly selected from the Canadian Medical Directory who had limited experience with HIV testing and counselling and who provided an appropriate mix of characteristics in terms of practice type (solo and group), setting (urban and rural), age and sex. A total of 1247 physicians were approached for the study; a convenience sample of 68 were recruited, of whom 56 participated. The average size of each focus group was eight physicians. OUTCOME MEASURES: Clinical experience and information sources with respect to HIV testing, reactions to the counselling guidelines, and suggestions for revisions and improvements to the guidelines. RESULTS: Most (96% [54/56] of the participants had ordered HIV serologic testing for patients in the 6 months preceding the focus groups, and about half of them (52% [28/54]) had at least one patient with a positive test result. Many (59% [33/56]) of the participants had a copy of the guidelines at the time of recruitment; 19 (58%) of them had used the guidelines in the months before the focus groups. The parts of the guidelines most often read were the checklists and inset boxes. Recommendations for revisions in content were for more information on legal and ethical issues, information on new issues (e.g., rapid testing) and guidelines on how best to tell a patient about a positive test result; recommendations for revisions in format included more tables, algorithms, bulleted points and white space, less text, larger type and plainer language. CONCLUSIONS: The focus groups provided detailed, credible and consistent information about the face and content validity of the HIV counselling guidelines. They are a useful qualitative method for evaluating the relevance, clarity and practicality of clinical practice guidelines at the inception or revision stage.

AIDS Serodiagnosis↗