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[Positive serology for syphilis in neonatal period: prevalence in secondary level maternity. Association with maternal risk factors and with positive serology for HIV-1].

To study neonatal Syphilis seropositivity incidence, its association with HIV-1 seropositivity and the impact of Congenital Syphilis CDC case definition, cord blood VDRL and Indirect Hemagglutination (IHA) for Syphilis were performed in 3,664 newborns from Dec/91-July/92. A positive group was formed by those with positive VDRL and IHA or just positive IHA. The control group consisted of 200 VDRL and IHA negative neonates. Among the 3,664 neonates 5.6% were seropositive for Syphilis. A significant association was noted (p < or = 0.05) between neonatal seropositivity for Syphilis and mothers older than 20 years, single, with sexual promiscuity, drug use, no pre-natal care, multiparity and previous still-births. All positive neonates fitted in the Presumptive Congenital Syphilis CDC definition. In 50 seropositive for Syphilis neonates ELISA for HIV-1 was performed and 6/50 were positive. Congenital Syphilis is of concern, specially in neonates of mothers with risk factors for Syphilis acquisition. HIV-1 should be considered in seropositive for Syphilis neonates. Adoption of Congenital Syphilis new CDC case definition is advised, particularly in countries where prenatal care is deficient.

AIDS Serodiagnosis↗

Serological markers for coeliac disease: changes with time and relationship to enteropathy.

UNLABELLED: Antigliadin antibodies (AGA) may be present in healthy adults. One previous study has reported that IgA-AGA detected by population screening may become negative after a 6-year follow-up period. OBJECTIVES: To determine the variability of coeliac disease-associated antibodies with time and to ascertain which antibodies are predictive of the presence of enteropathy. DESIGN: A clinical follow-up study of subjects with positive serological markers detected by screening at the time of the Belfast MONICA Project. METHODS: Jejunal biopsies were carried out endoscopically by means of a Crosby capsule. IgA-antigliadin was detected by a commercial ELISA; IgA-antiendomysial and antireticulin antibodies were determined by indirect immunofluorescence. RESULTS: Of 48 subjects followed up after 4 years, 28 (58%) had developed negative serology and 20 (42%) had persistently positive serology. Thirteen of 20 subjects with persistent serology had villous atrophy. Of 68 subjects followed up after 13 years, 32 (47%) had developed negative serology and 36 (53%) had persistent serology. Of 10 subjects with persistent serology who were biopsied, four had villous atrophy. None of the subjects who developed negative serology were found to have coeliac disease. CONCLUSIONS: Persistence of serological markers as a follow-up to a population screening programme may predict enteropathy in some subjects, whereas subjects who develop negative serology may be reassured. Subjects with persistent serology and normal histology require follow-up to determine if these markers are indicative of latent coeliac disease.

Biomarkers↗

The effect of a hepatitis serology testing algorithm on laboratory utilization.

RATIONALE, AIMS AND OBJECTIVES: Laboratory testing algorithms use patient and laboratory data to identify the optimal testing strategy for patients. Studies have shown that these algorithms can decrease test utilization. Since over-utilization of hepatitis serological tests was suspected, a hepatitis serology testing algorithm was initiated in Ontario, Canada. This study determined the effects of this algorithm on utilization. METHODS: Population-based retrospective observational study, involving all patients having viral hepatitis serological testing at private laboratories in Ontario, Canada, between July 1991 and December 1999. Prior to the testing algorithm, physicians listed the required specific antigens and antibodies on the test requisition form. In September 1996, the form was changed so that physicians identified the clinical indication--acute hepatitis, chronic hepatitis or immune status testing--for hepatitis serology testing. Therefore, the algorithm introduced a new 'tick-box' to the requisition form. Tests conducted by the laboratory depended upon which indication was chosen. Rates for hepatitis serological testing were calculated using population-based claims data. RESULTS: Time-series modelling showed that the testing algorithm was associated with a slight but significant increase in the use of hepatitis serology (P < 0.05). The algorithm was associated with an increase of 30 serological tests per 100,000 population per month. CONCLUSIONS: Introducing a testing algorithm for hepatic viral serology in Ontario did not significantly decrease hepatitis serology utilization and may be associated with a slight, but significant, increase in serology utilization rates.

Algorithms↗

Serology for Helicobacter pylori compared with symptom questionnaires in screening before direct access endoscopy.

This prospective study aimed to compare serology for Helicobacter pylori with two, symptom questionnaires in screening patients before direct access endoscopy. Methods were compared in terms of the number of endoscopies saved and pathology missed in 315 patients referred to a gastroenterology unit by 65 local GPs. The serology used was based on an acid glycine extract of H pylori. One in-house questionnaire was based on the Glasgow dyspepsia (GLADYS) system and the other questionnaire was that reported by Holdstock et al. A cut off point of 6.3 U/ml for H pylori serology was selected for screening patients (97% sensitive and 75% specific). Serology was combined with a history of NSAID usage in determining who should have endoscopy. For the in-house questionnaire, a cut off score of more than 8 out of a possible maximum of 18 was chosen, after prior evaluation in 118 patients referred for direct access endoscopy (the sensitivity for detection of peptic ulcer was 88%, specificity 61%). A cut off score of more than 412 was used for the Holdstock questionnaire. In patients under 45 years, serology detected more peptic ulcers than the in-house questionnaire and the Holdstock questionnaire (27/28 v 24/28, NS and v 20/28, p < 0.05 respectively). The Holdstock questionnaire saved significantly more endoscopies than the other two methods (76/149 v 57/149 for the in-house questionnaire, p = 0.05 and 59/149 for serology, p = 0.05). In all age groups combined, serology was significantly better than the in-house and Holdstock questionnaires at detecting peptic ulcers and gastric cancer (61/63, 52/63, p<0.02, and 50/63, p<0.01 respectively). But serology saved significantly fewer endoscopies (89/315, 135/315, p<0.005, and 119/315, p<0.05 respectively). Serology was inferior to the Holdstock questionnaire at detecting severe oesophagitis. It is concluded that serology is the method of choice in screening before direct access upper gastrointestinal endoscopy in those under 45 years. It best combines a high sensitivity for peptic ulcer disease with a large reduction in unnecessary negative endoscopies.

Adolescent↗

[Comparison of HLA class I typing by serology with DNA typing].

OBJECTIVE: To compare HLA class I typing by serology with PCR-SSP method in the Chinese population. METHODS: HLA-A and -B antigens were typed by serology with microlymphocytotoxicity and DNA typing with PCR-SSP in 525 clinical samples. Reliability, reproducibility and clinical practicability of both methods were compared according to the typing results. RESULTS: Serological typing for HLA class I was rapid and simple, costing 3 hours. The discrepancy rate between serology and PCR-SSP for HLA-A antigen was 9.0%, consisting of 21 antigens being incorrectly interpreted by serology and 26 of serological "blanks" turning out to be definable alleles by DNA typing. The discrepancy rate for HLA-B antigen was 12.2%, containing 39 antigens being incorrectly interpreted and 35 of serological "blanks" turning out to be definable alleles by PCR-SSP typing. DNA typing for HLA class I by PCR-SSP proved to be an accurate, reliable and well-reproducible technique within 5 hours. While it was difficult to suit clinical assay by a large scale screening because of complicated operation and high technical condition. CONCLUSION: DNA typing for HLA class I by PCR-SSP is suitable for clinical application in the Chinese population with a higher precision than serology. Screening test by serology is recommended. Ambiguous or blank antigens by serology should be retyped by DNA typing.

Adolescent↗

Polymerase chain reaction reveals Trypanosoma cruzi infection suspected by serology in cutaneous and mucocutaneous leishmaniasis patients.

The existence of patients suffering a double infection caused by Trypanosoma cruzi and Leishmania spp. has been suggested by several authors. Since the conventional serological tests now available for the diagnosis of Chagas' disease lack specificity due to the cross-reactivity between these two parasites, a serological confirmation of a T. cruzi infection cannot be made unless specific antigens are used. An enzyme linked immunosorbent assay (ELISA) to detect antibodies against a specific T. cruzi antigen, named Ag163B6, and immunoblotting using T. cruzi epimastigotes, are non-conventional serological techniques that could be employed for specific diagnosis of Chagas' disease. Using these two methods 34 cutaneous or mucocutaneous leishmaniasis patients were classified into two groups: (A) patients with serological evidence of T. cruzi infection, i.e. those who tested positive in at least one assay (18/34); and (B) patients with no serological evidence of T. cruzi infection, i.e. those who were negative for both assays (16/34). Taking into account the difficulties of xenodiagnosis and its low sensitivity (less than 50%) for a direct diagnosis in the chronic period of the disease, we used polymerase chain reaction (PCR) to confirm a T. cruzi infection in those leishmaniasis patients who presented positive results with the non-conventional serological techniques. Of the 18 patients with serological evidence of T. cruzi infection, 17 gave positive results when genomic DNA primers were used. Using minicircle primers, 15/18 of that group were positive. Nevertheless, all the patients suspected of being double infected were positive in at least one PCR test. Just one patient with no serological evidence of T. cruzi infection gave a positive PCR result when amplifying the minicircle sequence. The proof of the existence of a T. cruzi infection by PCR in leishmaniasis patients suspected to be chagasic when non-conventional serology was used, strongly supports the use of the specific Ag163B6 and immunoblotting with epimastigotes as specific serological diagnostic tools to determine a T. cruzi infection.

Animals↗

Comparison of HLA-A antigen typing by serology with two polymerase chain reaction based DNA typing methods: implications for proficiency testing.

Serology has been routinely used for class I HLA typing for the selection of donors for allotransplantation. However, serology is not adequate for the assignment of all class I specificities especially when testing non-Caucasians subjects and it is necessary to adopt new strategies for routine testing. At the present time the extent of incorrect serologic HLA-A assignments in clinical testing is not known. The polymerase chain reaction (PCR) based techniques have become useful standard clinical typing methods of HLA class II alleles but most laboratories still use serology for class I typing. In this report we have compared two PCR based techniques, PCR amplification with sequence-specific primers (PCR-SSP) and PCR amplification and subsequent hybridization with sequence-specific oligonucleotide probes (PCR-SSOP), for the assignment of HLA-A specificities in 56 blood samples from patients and families serologically typed for HLA-A. This side-by-side comparison of PCR methods showed 100% correlation between them. However, serology showed 7.1% misassignments and, in an additional panel of 19 cells where serology produced equivocal results, the PCR-SSP and SSOP methods identified the correct HLA-A specificity. Our results emphasize the need to complement routine serologic testing of HLA specificities with a small number of primers designed to test HLA-A34, A36, A43, A66, A74 and A80, that are not detected with high precision by serology. We concluded that the PCR-SSP and -SSOP methods can be used in routine HLA-A typing of patients and donors for transplantation with a greater precision than serology.

HLA-A Antigens↗

Serological response to syphilis treatment in HIV-positive and HIV-negative patients attending sexually transmitted diseases clinics.

BACKGROUND: HIV-positive patients treated for syphilis may be at increased risk for serological failure. OBJECTIVE: To compare follow-up serologies and serological responses to treatment between HIV-positive and HIV-negative patients attending two sexually transmitted disease (STD) clinics. STUDY DESIGN: Existing records were reviewed from HIV-positive patients who were diagnosed and treated for syphilis at the public STD clinics in Baltimore, Maryland, USA, between 1992 and 2000. Results of their serological follow-up were compared with those of HIV-negative clinic patients at the time of syphilis treatment. Failure was defined as lack of a fourfold drop in rapid plasma reagin (RPR) titre by 400 days after treatment or a fourfold increased titre between 30 and 400 days. RESULTS: Of the 450 HIV-positive patients with syphilis, 288 (64%) did not have documented follow-up serologies and 129 (28.5%) met the inclusion criteria; 168 (17%) of 1000 known HIV-negative patients were similarly eligible. There were 22 failures in the HIV-positive group and 5 in the HIV-negative group (p<0.001). The median times to successful serological responses in both groups were 278 (95% confidence interval (CI) 209 to 350) and 126 (95% CI 108 to 157) days, respectively (p<0.001). A multivariate Cox's proportional hazards model showed an increased risk of serological failure among the HIV-positive patients (hazards ratio 6.0, 95% CI 1.5 to 23.9; p = 0.01). CONCLUSION: HIV-positive patients treated for syphilis may be at higher risk of serological failure. Despite recommendations for more frequent serological follow-up, most patients did not have documentation of serological response after standard treatment for syphilis.

Adult↗

Serological studies of yaws in Thailand.

The serological aspects of anti-yaws campaigns are discussed. Serological reactions in untreated yaws are considered according to each type of lesion and by age-groups; the serological pattern in types I and II show much similarity in that the majority of cases fall in the high titre levels while with types IV and V there appears to be a more even distribution of cases at all titre levels. A uniform serological response is seen in the early lesions for all age-groups and this is also true of hyperkeratosis cases. There are more type IV cases among the younger age-groups showing high titres, while in the older groups there is an upward trend towards the negative side. Type V also shows a regressive serology.The serological response to treatment with penicillin in three different schedules (4 ml x 2, 2 ml x 2, and a single injection of 4 ml) is then compared. There was no marked difference between the response at the end of one year with all three schedules; with a larger amount of material, however, it is likely that the 2 ml x 2 dosage would be seen to be less effective than the other two schedules. Serological response to treatment with any schedule would be governed by the number of cases having a high initial titre among the group under consideration. The decrease in titre, after being comparatively rapid in the first six months after treatment, is slow, and reversal to seronegativity at the end of a year occurs only in a small number of cases.The role of mass serological examinations in large-scale campaigns is considered. While the serological approach is shown to be the only scientific one, the impracticability of mass serological investigation is brought out. It is stressed, however, that in a mass campaign a serological service is essential for pilot studies, orientation of incidence of latent yaws, check on diagnosis, and assessment of dosage and of the necessity for re-treatment.The possible reasons for prozone phenomena in slide flocculation tests are discussed. The presence of reagin-like substances of extraneous origin to treponemal infection, as well as of reagin, in yaws patients may be responsible for some of these phenomena.

Humans↗

Serological markers of cancer and their applications in clinical trials.

Strategies for the prevention of cancer include those aimed at reducing the incidence of cancer (primary prevention) and cancer mortality through early detection of tumors (secondary prevention). The efficacy of prevention interventions is evaluated by clinical trials. The conduct of clinical trials is aided by the use of serological indicators of the carcinogenic process measured using plasma or red or white blood cells. The accessibility and acceptability of obtaining blood samples for the measurement of serological markers of carcinogenesis permit widespread applications in the conduct of clinical trials. Serological markers must be shown to be valid and reliable before their use. Serological markers identify a variety of stages in the process of carcinogenesis such as inherited or acquired susceptibility to cancer, environmental exposures to carcinogens, biological effects of exposures, and the presence of preinvasive or invasive cancer. Serological markers may be used in clinical trials to select high risk but disease-free individuals for participation in clinical trials based on susceptibility factors or carcinogenic exposures. Other uses of serological markers include monitoring adherence to interventions and establishing trial outcomes of intermediate cancer end points or incident invasive disease. Examples of these applications are discussed. Serological markers of carcinogenesis have widespread applications in clinical research and potentially for clinical practice. Currently, the only limitation to their widespread use is the availability of validated serological markers. Because of the ease and acceptability of their use, research into the development of serological markers should continue. Methods for quickly validating serological markers should be developed in order to aid the transition to clinical applications.

Biomarkers, Tumor↗