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PubMed1999

A prospective study of the influence of HIV status on the seroreversion of serological tests for syphilis.

UNLABELLED: The evolution of serological tests for syphilis (STSs) after therapy in HIV+ patients is a major point of controversy, with possible seroreactivation and illicit seroreversion in these patients. The aim of our study was to evaluate the long-term outcome of STSs in a cohort of HIV+ male homosexuals with a history of treated syphilis as compared with HIV- controls. PATIENTS AND METHODS: Sixty-nine HIV+ male homosexuals with a documented history of treated syphilis and positive baseline treponemal tests were prospectively studied between 1986 and 1993. A medical examination, HIV staging, CD4+ cell count, VDRL, FTA-Abs tests and TPHA were performed every 6 months. Controls consisted of 49 HIV- patients with similar inclusion criteria over the same period. Comparisons between subgroups were based on chi(2) and Kruskal-Wallis tests. Analysis of negativation of the STS used the failure data methods (Kaplan-Meier, log-rank and Cox's model). RESULTS: Patients had a mean age of 38 years, a baseline CD4+ cell count of 578/mm(3), elapsed time since last syphilis of 7.5 years and a median follow-up of 4.3 years. Controls had a mean age of 42 years, elapsed time since last syphilis of 5.3 years and a median follow-up of 4.7 years. Time to seroreversion was shorter in HIV+ patients for TPHA (p = 0.009, log-rank test) and FTA-Abs test (p = 0.001, log-rank test), even after adjustment for stage of syphilis, age and time since the last episode of syphilis. The decrease in VDRL titres was not different between the 2 groups (p = 0.053, log-rank test). Seroreversion of the TPHA, FTA-Abs test and VDRL test was not significantly related to stage of syphilis, time elapsed since the last episode of syphilis, age or history of STDs in both groups. Seroreversion of the TPHA and VDRL test was not related to baseline CD4+ cell count. However, seroreversion of the FTA-Abs test was related to a low baseline CD4+ cell count (p = 0. 003). In HIV+ patients, a significant decrease in titres was noticed for TPHA, FTA-Abs test and VDRL test over time, but this time effect remained only for TPHA titres after adjustment for the CD4+ cell count. CONCLUSION: TPHA may serorevert in HIV+ patients. Thus, a non-reactive TPHA does not exclude a past syphilis infection in such patients. Evolution of the VDRL test after therapy is regular in HIV+ patients. The VDRL test remains adequate for controlling the efficacy of treatment in these patients.

Adult↗

PubMed1994

Serological tests for Lyme disease in patients with tropical spastic paraparesis and healthy Jamaicans.

The significance of reactive serological tests for Lyme disease in patients with tropical spastic paraparesis (TSP) was assessed by examining serum samples from 128 of these patients and 200 healthy Jamaicans by Lyme indirect immunofluorescent antibody (IFA), enzyme immuno-assay (EIA) and Western blot analyses. Sera were also examined in serological tests for syphilis (STS), an unabsorbed fluorescent treponemal antibody test and leptospira microagglutination test. The prevalence of positive Lyme IFA and EIA results did not differ significantly between sera from TSP patients (12.5%) and healthy controls (10.0%). Western blot analyses showed that the positive Lyme IFA and EIA results observed in this study were due to false positive reactions. Seventy-five per cent of Lyme IFA/EIS positive sera from TSP patients had treponemal antibodies. Eighty per cent of those from healthy controls were negative in standard STS but 85% were positive when tested in an unabsorbed fluorescent treponemal antibody (FTA). These data indicate that reactive serological tests for Lyme disease in Jamaican TSP patients and healthy Jamaicans are false positive reactions due to cross-reactivity with other spirochaetes, notably Treponema pallidum and non pathogenic treponemes.

Adolescent↗

PubMed2026

Management of neonates born to mothers with reactive serologic tests for syphilis.

PURPOSE OF REVIEW: The dramatic resurgence of maternal and congenital syphilis in the United States highlights the need for their optimal management as syphilis in pregnancy can result in substantial neonatal morbidity and mortality. This review summarizes current epidemiology and discusses guidance on the management of neonates born to mothers with reactive serologic tests for syphilis. RECENT FINDINGS: Timely communication with local health department professionals is essential for optimal management of mothers with reactive serologic tests for syphilis and their neonates. Knowledge of maternal syphilis treatment history by partnering with local jurisdictions can circumvent much of the incertitude surrounding neonatal management. All neonates born to mothers with reactive serologic tests for syphilis should be tested using a nontreponemal ('lipoidal antigen') test. However, a reactive test may only indicate maternal nontreponemal IgG antibodies that are transferred transplacentally to the fetus. Therefore, neonatal management depends on maternal history and treatment for syphilis as well as clinical, laboratory, and radiographic findings in the neonatal evaluation. Existing management algorithms are complex, highlighting the need for a more practical, yet safe, approach. SUMMARY: A neonatal management guideline is proposed that may simplify the management of neonates born to mothers with reactive serologic tests for syphilis while advocating for expanded use of single-dose benzathine penicillin G therapy.

Humans↗

PubMed1999

Evaluation of six serological tests in diagnosis and postoperative control of pulmonary hydatid disease patients.

Latex agglutination (LA), passive hemagglutination (PHA), immunoelectrophoresis (IEP) and specific IgE, IgM, IgG enzyme-linked immunosorbent assay (ELISA) tests for diagnosis and postoperative follow-up of 79 patients with surgically confirmed pulmonary hydatidosis were evaluated. Specific IgG ELISA was the most sensitive test (83.5%) and the least sensitive tests were specific IgE ELISA (44.3%) and IEP (50.6%). The specificity obtained for all the serologic test was above 97% in all cases. The greatest number of false positives in all tests (except IEP) occurred in patients with Taenia saginata and Taenia solium cysticerci infestations and in patients with lymphoma and leukemia. Specific IgG ELISA demonstrated the highest negative predictive value (93.8%). No statistically significant differences (p > 0.050) were found in the sensitivity of the tests when patients with only one cyst and patients with various cysts were compared. Considering only the patients without relapse, the percentage of seropositive patients increased in all tests at 1 and 3 months after surgery. After that time the percentage of seropositive patients decreased. At 48 months after surgery all patients without relapse became negative in IEP, specific IgE ELISA, and specific IgM ELISA. The antibody titers in all seropositive patients increased during the 3 months after surgery. From these 3 months onward, antibody levels decreased in all serologic tests studied in the group of patients without relapse. The patients who had relapses during the first year after surgery presented persistently elevated antibody titers in all postoperative sera. The antibody titers of the patients who relapsed between the third and fourth years after surgery decreased progressively the third month after surgery, and increased in the serum obtained at the moment of relapse diagnosis. Our results show that persistence of elevated antibody titers in patients with pulmonary hydatidosis in the year after surgery or titer increase after a progressive decrease are indicative of relapse or reinfection.

Antibodies, Helminth↗

PubMed1996

Detection of coccidioidal antibodies by 33-kDa spherule antigen, Coccidioides EIA, and standard serologic tests in sera from patients evaluated for coccidioidomycosis.

During a 9-month study of patients being evaluated for coccidioidomycosis, 1 or more serum samples were obtained from 138 patients with an illness suggestive of recent infection. In this group, standard immunodiffusion tests of unconcentrated sera were positive for 25; 49 additional patients had at least 1 reactive test result by newer enzyme-linked serologic tests. At least 11 of these 49 patients had coccidioidomycosis as determined by culture or subsequent standard serologic tests. Patients with coccidioidomycosis identified only by newer tests had fewer or milder clinical abnormalities than did patients in whom the disease was detected by standard tests. For 31 other patients with illness of a chronic or undetermined duration, newer tests detected only 10 more than the 18 identified by standard tests, suggesting that later in the course of illness, standard testing gains in sensitivity for coccidioidal infection.

Antibodies, Fungal↗

PubMed2001

Evaluation of five commercial serological tests for the detection of Helicobacter pylori infection in Chinese.

BACKGROUND: Commercial serological tests for the detection of Helicobacter pylori infection must be locally validated. We evaluated the accuracy of five commercial tests in the Chinese population. METHODS: Serum samples were collected from patients referred for upper endoscopy. Antral biopsies were taken for histological examination and culture of H. pylori. The gold standard for diagnosing H. pylori infection was positive histological staining and/or positive H. pylori culture. The serum samples were tested for H. pylori antibodies using the following tests: (i) Cobas Core Anti-H. pylori EIA; (ii) GAP IgG; (iii) GAP IgM; (iv) H. pylori microwell EIA (Quidel); and (v) Premier H. pylori. The sensitivity, specificity and accuracy of each test was calculated according to the manufacturers' instructions or according to a new cut-off value. RESULTS: A total of 158 patients were recruited amongst whom 114 (72%) were H. pylori-positive. Indeterminate results varied from 7% to 19%. The accuracy of the tests varied from 57% to 85%. By using new cut-off values, the accuracy was much improved, ranging from 73.4% to 86.7%. CONCLUSIONS: By defining new cut-off values for the Chinese population, we were able to improve the performance of some of the serology tests. This illustrates the importance of local validation.

Adolescent↗

PubMed1958

Treponemal serologic tests; experiences of the Bacteriology Laboratory, California State Department of Public Health.

In a study of the relationship of clinical impression regarding syphilis and age, sex and pregnancy status to treponemal serologic test reactivity, it was noted that in diagnostic "problem cases" the standard lipid serologic test titers did not differentiate between syphilitic and biologic false positive reactors. Preliminary data indicated that heroin addiction may be a source of biologic false reactions and that pregnant women with standard serologic test reactivity have a lower treponemal reactivity rate than other women with lipid serologic reactivity.

Bacteriology↗

PubMed1995

ELISA inhibition test using monoclonal antibody specific for Treponema pallidum as the serologic test for syphilis.

Monoclonal antibodies (Mabs) specific for Treponema pallidum were produced using hybridoma technology. In this study an ELISA inhibition test based on competitive inhibition by antibodies from human test sera of the binding of the enzyme-labelled Mabs to T. pallidum was performed. Inhibition of the seroreactivity of Mabs was decreased according to the dilution of rabbit antiserum to T. pallidum. Seropositivity was found in 100% of secondary and early latent syphilis patients, 75% of primary syphilis patients, and 80% of late latent syphilis patients. The mean percentage inhibition was significantly higher in each syphilis group than in the controls, and statistically significant differences were shown between all the syphilis groups. VDRL and TPHA titers were correlated with the percentage inhibitions. Therefore the ELISA inhibition test using Mab specific for T. pallidum might well be a suitable tool as a new serologic test for syphilis.

Analysis of Variance↗

PubMed1995

Hemoconcentration prior to serology testing in hemodiluted cadaver bone and tissue donors.

Concern about false negative serology tests for infectious diseases in hemodiluted cadaver donors resulted in issuance of new regulations and guidelines from the FDA and CDC. Bone or tissue from donors receiving > or = 4 units of blood, blood products, colloids or crystalloids within 48 h of sampling must be quarantined unless: (a) a pretransfusion serum is available; or (b) an adequate algorithm is employed to ensure hemodilution is insufficient to alter test results, i.e. cause false negatives. Left undefined in these regulations is, what is an adequate algorithm and what amount of hemodilution would cause false negatives. A pretransfusion sample was not available for about 20% of our donors and many had incomplete infusion histories. We used the unambiguous quantitation of serum albumin and total protein to define hemodilution and, if present, hemoconcentration of sera by ultrafiltration to normal protein levels prior to serology testing. Control experiments showed excellent correlation between serum dilution and protein concentration (r > 0.99) and a quantitative recovery of 96.9 +/- 1.4% upon hemoconcentration. Known positive sera (CMV-Ab; HTLV-1Ab; HIV-1,2Ab; HBsAb; HCV-Ab; HBsAg) were spiked into normal sera and diluted up to 1:2000, well beyond detectable levels. A qualitative recovery of 100% and a quantitative recovery of 97.6 +/- 7.5% of antibody or antigen reactivity was achieved upon hemoconcentration and retesting. In two studies, 14% (30/210) and 43% (23/54) of cadaver donors had serum proteins below normal limits and their sera was hemoconcentrated.(ABSTRACT TRUNCATED AT 250 WORDS)

Algorithms↗

PubMed1997

Utilization and cost of serologic tests for Lyme disease in Maryland.

To ascertain use of serologic tests for Lyme disease (LD) in Maryland, all laboratories registered with the State Health Department were surveyed. Results show that from 1992 to 1995, 17 laboratories performed 100,000 serologic tests costing $7.1 million on Maryland residents; 90% of these tests were EIAs. The proportion of positive EIAs increased from 3.4% in 1992 to approximately 7.0% in 1994 and 1995, and the percentage of positive second tests (Western blot, WB) fell from 7.9% to 5.0%-5.5%. The large number of EIAs performed in comparison with the low incidence of LD in the state results in a low predictive value of a positive EIA test. Therefore, the WB is indicated to confirm equivocal and positive EIA tests when characteristic clinical findings of LD are not present. The 30,000 tests for LD performed annually on Maryland residents at a cost of over $2 million in direct medical costs must be added to the public health burden of LD in this state.

Blotting, Western↗

PubMed2000

Comparison of serologic testing and slaughter evaluation for assessing the effects of subclinical infection on growth in pigs.

OBJECTIVE: To compare serologic testing with slaughter evaluation in assessing effects of subclinical infection on average daily weight gain (ADG) in pigs. DESIGN: Cohort study. ANIMALS: 18 cohorts (30 to 35 pigs/cohort) of pigs on/farms. PROCEDURE: Blood samples were collected, and pigs were weighed at 8, 16, and 24 weeks of age. Sera were tested for antibodies to porcine reproductive and respiratory syndrome virus (PRRSV), swine influenza virus (SIV), transmissible gastroenteritis virus (TGEV), pseudorabies virus, Mycoplasma hyopneumoniae, and Actinobacillus pleuropneumoniae. At slaughter, skin, nasal turbinates, lungs, and liver were examined. Associations between ADG and results of serologic testing and slaughter evaluation were examined by use of multiple linear regression. RESULTS: Pathogens that had a significant effect on any given farm during any given year and the magnitude of that effect varied. However, at 16 and 24 weeks of age, a higher antibody titer was consistently associated with a lower ADG. Mean differences in ADG between seropositive and seronegative pigs were 18 g/d (0.04 lb/d) for SIV, 40 g/d (0.09 lb/d) for PRRSV, 38 g/d (0.08 lb/d) for M hyopneumoniae, and 116 g/d (0.26 lb/d) for TGEV. Of the evaluations performed at slaughter, only detection of lung lesions was consistently associated with a decrease in ADG. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggest that subclinical infection with any of a variety of pathogens commonly found in swine herds was associated with a decrease in ADG. Serologic testing was more effective than slaughter evaluation in assessing the impact of subclinical infection on ADG in these pigs.

Actinobacillus Infections↗

PubMed2006

Assessment of prescription practices for serological tests for viral hepatitis B and C in the Greater Parisian area in 2002.

OBJECTIVES: The aim of this study was to ascertain the reasons for the prescription of serological tests for viral hepatitis B (HBV) and C (HCV) in the Greater Parisian area, and to assess standards of prescription with respect to current guidelines. PATIENTS AND METHODS: The population studied comprised patients affiliated to the three main health insurance schemes in the Greater Parisian area, for whom at least one serological test for HBV or HCV was reimbursed on May 14th or 15th, 2002. Data was collected from prescribing and laboratory heads. RESULTS: The sample consisted of 1 046 prescription orders for HBV and/or HCV tests. The mean age of patients was 39 years, and 68% were females. The main medical indications declared by the prescribing physicians were: screening for HBV or HCV (40%), tests for pregnant women (19%), suspected hepatitis B or C (13%), pre- and post-vaccination tests for HBV (7%), medically assisted procreation (6%), follow-up of diagnosed chronic hepatitis (4%). Assessment of the standards of prescription orders showed a lack of compliance with guidelines for 71% of HBV tests, and 56% of HCV tests. CONCLUSIONS: The implementation of guidelines for the prescription of serological tests for HBV and HCV needs to be improved in clinical practice.

Adolescent↗

PubMedDate not supplied

An audit of serological tests carried out at clinical laboratory of Ayub Teaching Hospital, Abbottabad.

BACKGROUND: Clinical audit is an important tool for reviewing and improving the quality of service in clinical laboratories. Here we present an audit of total serology test requests and the frequency of positive tests out of these in a calendar year. METHODS: This is an audit of serology tests carried out at Microbiology section of Clinical Laboratory of Ayub Teaching Hospital, Abbottabad. We counted all the serology test requests for the year 2004. These tests requests were grouped month wise. The frequency of positive tests out of the total test requests were calculated. The tests included Widal, Toxoplasma, Brucella, Anti DNA, Anti Nuclear factor (ANF), Rheumatoid Arthritis Factor (RAF), HIV, HBsAg, HCV, Intra Chromatographic Technique for tuberculosis (ICT-TB), Purified Protein Derivative (PPD), Venereal Disease Research Laboratory (VDRL) test, Anti-Streptolysin-O-test (ASOT) and pregnancy test. RESULTS AND CONCLUSIONS: This audit gives a clear idea of trends of test requests in our hospital. It reflects accuracy of clinicians' judgment in some tests and failure in others, prevalence of different diseases, seasonal variation in number of test requests for some tests and impact of awareness campaigns on attitude of clinicians towards certain diseases. This will help us in planning our laboratory requirements to improve quality.

Communicable Diseases↗

PubMed1998

The ChemTrak Hp Chek fingerstick whole blood serology test for the detection of Helicobacter pylori infection.

OBJECTIVE: To evaluate a new whole blood serology test (Hp Chek; ChemTrak) that detects IgG antibodies to Helicobacter pylori. METHODS: The study was conducted at 10 sites within the United States. Patients undergoing upper endoscopy for dyspepsia were recruited for enrollment. Those treated for H. pylori infection within a year of endoscopy and those who had regularly used proton pump inhibitors, bismuth compounds, or antibiotics within a month of endoscopy were not eligible. During endoscopy, specimens were obtained from the corpus and antrum for histological examination, which was performed by a single experienced pathologist. The Hp Chek was tested using whole blood and serum. Serum was also tested with a reference enzyme-linked immunosorbent assay (ELISA) at a centralized location. Test characteristics for the Hp Chek and ELISA were calculated using histology as the "gold standard." RESULTS: Two hundred eighty-seven patients (140 women and 147 men; mean age 53 +/- 6 yr) were enrolled. The Hp Chek was easy to perform and yielded results 9 min after inoculation of the test cassette with whole blood or serum. When the Hp Chek used with whole blood was compared with histology as the gold standard, the sensitivity was 88%, specificity 85%, positive predictive value 83%, negative predictive value 90%, and percent agreement 86%. There were no statistically significant differences among the results obtained with the Hp Chek using whole blood, the Hp Chek using serum, or reference ELISA. CONCLUSIONS: The Hp Chek whole blood serology test was easy to perform and rapid and yielded performance characteristics comparable to those of a reference ELISA or the Hp Chek used with serum.

Analysis of Variance↗

PubMed1999

An unexpected result in an evaluation of a serological test to detect syphilis.

Traditional tests for detection of syphilis are labour intensive and costly. Enzyme immunoassays (EIAs) are readily automated and cost effective if large numbers of tests are performed. Four experiments were devised to evaluate a syphilis EIA test kit where resources are limited: (1) testing antenatal patients; (2) testing refugees; (3) testing a high prevalence population; and (4) testing "problem sera" (containing autoantibodies or antibodies to other infective agents). Forty-one available syphilitic sera from antenatal patients were tested to evaluate sensitivity. Specificity was determined through testing sera determined to be nonreactive with rapid plasma reagin and Treponema pallidum hemagglutination tests, calculating the sample size (456) on the confidence interval (CI) required. Two runs were performed on antenatal sera, giving sensitivities of 32% (95% CI: 20%, 47%) and 37% (95% CI: 24%, 52%) and specificities of 92% (95% CI: 89%, 94%) and 90% (95% CI 87%, 92%), respectively. We present a method to evaluate a serological test where resources are limited. Unexpectedly, the test kit performed poorly as a screening test. New serological tests need to be evaluated in-house prior to adoption.

Adult↗

PubMed2005

Specificity dependence between serological tests for diagnosing bovine brucellosis in Brucella-free farms showing false positive serological reactions due to Yersinia enterocolitica O:9.

When brucellosis false positive serological reactions happen in cattle, the serial use of pairs of specificity-correlated serological tests (rose bengal, complement fixation, competitive ELISA) results in specificities lower than expected. In this situation, highly specific tests, such as the indirect ELISA used alone, may be more adequate than serial testing.

Agglutination Tests↗

PubMed2004

International Commission on Trichinellosis: recommendations on the use of serological tests for the detection of Trichinella infection in animals and man.

The use of serological tests to detect Trichinella infection in domestic and wild animals and in humans has not been standardised yet. This review provides an uniform set of recommendations for the development and use of serological tests to detect circulating antibodies in serum samples. The recommendations are based on the best scientific published information and on the unpublished data from laboratories with a great expertise in this field and represent the official position of the International Commission on Trichinellosis regarding acceptable methods and the evaluation of the sensitivity and specificity. These recommendations are subject to change as new scientific information becomes available.

Animals↗

PubMed2005

What are the sensitivity and specificity of serologic tests for celiac disease? Do sensitivity and specificity vary in different populations?

A number of serologic tests are available commercially for identifying individuals who require an intestinal biopsy examination to diagnose celiac disease (CD). The aim of this study was to determine which test, or combination of tests, was most sensitive and specific for this purpose. We performed a literature review of studies that determined the sensitivity and specificity of serologic tests for CD. Studies that compared biopsy examination-confirmed cases of CD with controls with normal intestinal histology were selected for analysis. Sensitivities and specificities for the antigliadin tests were highly variable. Immunoglobulin (Ig)G-based antigliadin (AGA) tests generally were poor in both parameters whereas the IgA-based test was poorly sensitive but more specific. The IgA endomysium (EMA-IgA) and tissue transglutaminase (TTG-IgA) tests were both highly sensitive and specific with values for both parameters exceeding 95% in most studies. There were no identifiable differences between adults and children with respect to these tests. There was no evidence that a combination of tests was better than a single test using either the EMA IgA or TTG IgA. Either the EMA-IgA or TTG-IgA test is most useful for identifying individuals with CD. The variability and generally lower accuracy associated with the AGA tests make them unsuitable for screening purposes. There is no advantage to using a panel of tests as opposed to a single test. Because these data were obtained largely from studies conducted in a research setting, it is possible the tests will be less accurate when used in the clinical setting.

Case-Control Studies↗