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PubMed2002

Optimal serological tests for the detection of Helicobacter pylori infection in the Chinese population.

BACKGROUND: Numerous serological tests for the detection of Helicobacter pylori infection have been developed. However, many perform poorly when evaluated in the Chinese population. AIM: To search for optimal serological tests for the detection of H. pylori infection in Chinese patients. METHODS: Consecutive dyspeptic patients referred for upper endoscopy were recruited. During endoscopy, gastric biopsies were taken for the CLOtest and histological examination. Patients were then given a 13C-urea breath test. Sera were used to test for H. pylori infection, employing three commercial enzyme-linked immunosorbent assay kits (pylori DTect, HP IgG and GAP IgG). Results were compared with the gold standard defined by the CLOtest, histology and 13C-urea breath test. RESULTS: Among the 142 patients (47 male, 95 female; mean age, 49 years) recruited, 81 (57%) were H. pylori-positive, 57 (40%) were H. pylori-negative and four (3%) were defined to be indeterminate. Using a self-defined cut-off value after calculation, the best accuracies for the pylori DTect, HP IgG and GAP IgG tests were 97%, 91% and 80%, respectively. CONCLUSIONS: The pylori DTect test is an optimal serological test for the detection of H. pylori infection in Hong Kong Chinese patients. The HP IgG test may be used as an alternative.

Breath Tests↗
PubMed1998

A new histological procedure for re-evaluation of the serological test for Helicobacter pylori.

To re-evaluate the accuracy of the serological test for Helicobacter pylori, fixation of biopsy specimens with Carnoy's solution (preserving the mucous layer in tissue preparations) followed by immunohistochemical staining (a new histological procedure) was used as the reference histological method instead of 10% formalin fixation followed by hematoxylin-eosin staining (the conventional histological procedure). Biopsy specimens (antrum and body) from 114 patients with gastritis (including non-ulcer dyspepsia) or gastric and/or duodenal ulcers were obtained by endoscopy and used for both bacteriological culture and histological examination. Serum samples were taken from all patients at the time of endoscopy. The serum levels of specific IgG and IgA antibodies for Helicobacter pylori were measured by commercial enzyme immunoassay kits. The reliability of the IgG and IgA measurements was evaluated by analyzing receiver operating characteristic curves obtained using the two histological procedures. With the conventional histological procedure as the reference, the sensitivity and specificity levels of the serological test were 87.2% and 82.1%, respectively. With the new histological procedure as reference, sensitivity and specificity were 94% and 96.7%, respectively. The insufficient accuracy reported for the serological test could be due to false-positive or false-negative results obtained when the conventional histological procedure is used as the reference. The new histological procedure used here revealed that the serological test for Helicobacter pylori is more reliable than previously thought.

Antibodies, Bacterial↗
PubMed2005

HIV incidence among injection drug users in New York City, 1990 to 2002: use of serologic test algorithm to assess expansion of HIV prevention services.

OBJECTIVES: We sought to estimate HIV incidence among injection drug users (IDUs) in New York City from 1990 to 2002 to assess the impact of an expansion of syringe exchange services. Syringe exchange increased greatly during this period, from 250,000 to 3,000,000 syringes exchanged annually. METHODS: Serum samples were obtained from serial cross-sectional surveys of 3,651 IDUs. HIV-positive samples were tested with the Serologic Test Algorithm for Recent HIV Seroconversion (STARHS) assay to identify recent HIV infections and to estimate HIV incidence. Consistency with other incidence studies was used to assess strengths and limitations of STARHS. RESULTS: HIV incidence declined from 3.55/100 person-years at risk (PYAR) from 1990-1992, to 2.63/100 PYAR from 1993-1995, to 1.05/100 PYAR from 1996-1998, and to 0.77/100 PYAR from 1999-2002 (P<.001). There was a very strong negative linear relationship (r= -.99, P<.005) between the annual numbers of syringes exchanged and estimated HIV incidence. These results were highly consistent with a large number of shorter incidence studies among IDUs conducted during the time period. CONCLUSIONS: STARHS testing of samples from large serial cross-sectional surveys can provide important data for the assessment of community-level HIV prevention.

AIDS Serodiagnosis↗
PubMedDate not supplied

The photometric latex test for rheumatoid factors in patients with rheumatoid arthritis. I. correlation with other serologic tests.

The photometric latex test (PLT) for the detection of rheumatoid factors (RF) has been correlated with the sensitized sheep cell test (SSC) and the latex slide test (LST). A total of 377 sera from patients with rheumatoid arthritis (RA) and 120 sera from control subjects were examined. When the PLT was carried out on the native sera at a lower buffer ionic strength (0.05 M), agglutination was noted in over 99% of cases, indicating interaction of complement with human immunoglobulin bound to the latex particle surface. Although thermal inactivation eliminated most of the complement agglutination, an increase in ionic strength (0.5 M) was found to be essential for measuring only RF agglutination. The serologic data were analysed statistically by computer. A highly significant correlation was found between all serologic tests and RA sera, but there was no such correlation with the control sera. The specificity of all tests was generally over 90% and did not vary significantly, but the sensitivity varied from 52.0% to 71.1%, confirming that about one-third of all RA patients are seronegative. The tests were analysed for their total diagnostic capability. The PLT with native sera at higher ionic strenght proved to be the most sensitive, but with thermally inactivated sera it had a better diagnostic capacity. The SSC test appeared to be less sensitive and of lower diagnostic validity. Rapid LST tests were clearly inferior to PLT tests. The PLT can be used as a reliable and straightforward serologic method of diagnosis in RA, especially when carried out at a higher ionic strength and with thermally inactivated sera. It should be given preference over other serologic tests for RF and could well become standard practice in rheumatologic serology as a substitute for the SSC test.

Arthritis, Rheumatoid↗
PubMed1990

[False positive serological tests for Borrelia burgdorferi in patients with primary antiphospholipid syndrome].

Serological tests for Borrelia burgdorferi were carried out in a series of 27 patients with primary antiphospholipid syndrome (PAPLS). The results showed a 14% prevalence of false positive Lyme disease serology in this patient population. In patients with PAPLS and false positive serologic tests for Borrelia burgdorferi neurological involvement was significantly more common (p = 0.012, Fisher's exact test) than in patients with PAPLS without that finding. We insist on the possibility that patients with PAPLS may have false positive serological tests for Borrelia burgdorferi as measured by IFI with the resulting diagnostic error. In these cases, confirmation by other techniques such as ELISA or immunoblotting is recommended.

Adult↗
PubMed2000

Accuracy and utility of commercially available amplification and serologic tests for the diagnosis of minimal pulmonary tuberculosis.

Diagnosis of patients with minimal active tuberculosis (TB) is difficult, as there is no single test with high sensitivity and specificity. The yield and clinical utility of a combination of diagnostic tests were prospectively studied among 500 consecutive patients referred for sputum induction for diagnosis of possible active TB. Patients underwent sputum induction, chest X-ray, tuberculin testing, and had blood drawn for serologic testing (Detect-TB test; Biochem ImmunoSystems). Sputum was examined with fluorescent microscopy and PCR (Amplicor MTB-Roche) and cultured for mycobacteria using liquid (BACTEC) and solid media. For the diagnosis of the 60 cases of active TB, sensitivity and specificity, respectively, of the following diagnostic tests were mycobacterial culture, 73% and 100%; PCR, 42% and 100%; chest X-ray, 67-77% and 66-76%; tuberculin testing, 94% and 20%; and serology, 33% and 87%. After consideration of PCR and radiographic and clinical characteristics, a positive serologic test was independantly associated with diagnosis of active disease (adjusted odds of disease if positive, 2.6; 95% confidence limits, 1.1,6.1). No currently available test has sensitivity and specificity high enough for the accurate diagnosis of minimal pulmonary TB. Utilization of a combination of tests, together with consideration of key clinical characteristics, could improve diagnostic accuracy.

Adult↗
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↗
PubMed1956

Biologically false positive reactions to serological tests for syphilis.

The frequency of biologically false positive reactions to serological tests for syphilis depends on a number of factors, including the individual immunological response, the number and type of serological tests performed, and the stage of the disease producing such reactions; the relative importance of such factors is discussed. The author also considers in detail the diseases or conditions giving rise to acute or chronic biologically false positive reactions.A variety of verification tests exists for differentiating the true syphilitic reaction from the biologically false positive reaction, but none is so accurate as the Treponema pallidum immobilization and immune adherence tests, which the author considers should be used when others have proved inconclusive. In the final section of his paper, he indicates the steps to be followed in attempting to distinguish between latent syphilis and biologically false positive reactions in persons with positive serological tests but no anamnestic or clinical evidence of syphilis.

Child↗
PubMed2006

Serologic testing for symptomatic coccidioidomycosis in immunocompetent and immunosuppressed hosts.

Serologic studies are an important diagnostic tool in the clinical evaluation and follow-up of persons with coccidioidomycosis. Numerous types of serologic tests are available, including immunodiffusion, enzyme immunoassay, and complement fixation. We conducted a retrospective review of the results of 1,797 serologic tests spanning 12 months from the onset of coccidioidomycosis in 298 immunocompetent and 62 immunosuppressed persons with symptomatic infection. Using the onset of symptoms as a reference point, we plotted the positive or negative serologic results over time for both groups. Compared with the immunocompetent group, immunosuppressed persons had lower rates of seropositivity for every type of test during the first year after onset of symptoms for coccidioidomycosis, although many results did not achieve statistical significance. Combining the results of these tests increased the sensitivity of the serologic evaluation in immunocompromised patients. Immunosuppressed persons have the ability to mount a serologic response to coccidioidomycosis, but in some circumstances, multiple methods may be required to improve detection.

Aged↗
PubMed1990

Significance of false-positive serologic tests for histoplasmosis and blastomycosis in an endemic area.

False-positive serologic tests for histoplasmosis (H) and blastomycosis (B) are common in populations from endemic areas. In order to determine the significance of false-positive test results, we reviewed the final diagnoses of all patients whose sera were submitted to our laboratory for radioimmunoassay (RIA) and immunodiffusion (ID) during a 3-yr period. Of the 263 patients whose sera were examined, 29 (11%) had H or B; 41 (17.5%) of the remaining 234 patients had false-positive test results. Of these 41 patients, 31 were positive for H alone, and 10 had antibodies to both H and B. All three patients with false-positive ID tests for histoplasmosis also had positive titers (greater than or equal to 1:16) on RIA. No patient had a false-positive ID result for blastomycosis. The percentage of patients in each of five major diagnostic categories with and without false-positive serologic tests was similar (p greater than 0.05). The majority of patients had pulmonary infections, almost half of which were granulomatous infections other than H or B; this reflects the clinical indications for requesting fungal serologic tests. A positive fungal serology is not useful in suggesting the presence of a pulmonary disease other than H or B in patients from an endemic area suspected of having a pulmonary mycosis.

Blastomycosis↗
PubMed1990

Serologic tests for Lyme disease. Interlaboratory variability.

The serologic test for the detection of antibodies to Borrelia burgdorferi is the most frequently used laboratory method for the diagnosis of Lyme disease. However, the insensitivity of the assays and the interlaboratory variability are frequent problems. To determine the extent of this variability, one aliquot of serum from each of nine patients with a history of Lyme disease was sent to nine reference laboratories, including national, university, state, and local hospital laboratories. A second aliquot of the original serum was submitted 2 weeks later. Wide variability among laboratories was observed, ranging from a university laboratory that detected antibody to B burgdorferi (IgG or IgM) in 18 of 18 specimens, to a state laboratory that detected antibody in only 8 of 18 specimens. Detection of IgM specific antibodies showed similar variability (range, 2 to 10 of 18). There were eight instances of a fourfold or greater change in titer between the aliquots sent 2 weeks apart, although only three of these were an increase in titer. These results indicate the need for standardization of the assays and the availability of national reference material. It is recommended that the results of serologic testing should not be relied on as the sole criteria in making the diagnosis of Lyme disease.

Antibodies, Bacterial↗
PubMed1977

Laboratory evaluation of serological tests for systemic candidiasis: a cooperative study.

Three serological tests for candidiasis, agar gel diffusion (AGD-1), whole cell agglutination (AGGL-1), and latex agglutination (LAT), were evaluated by six laboratories with 100 coded sera. In addition, each of six laboratories performed a test of its choice, either the AGD-2, the AGD-3, the AGGL-2, or one of three counterimmunoelectrophoresis (CEP) methods (CEP-1, CEP-2, and CEP-3). Results are presented by laboratory for a group of 53 "candida-involved" cases (33 proven, 14 presumptive, and 6 probable) and 47 negative controls (41 normal and 6 other disease states). The AGD-1 test produced an overall average of 85.1% positive results in the candida-involved group and 5.0% positives in the control group. The LAT produced an overall average of 89.0% positives in the candida-involved group and 17.4% positives in the controls. The AGGL-1 test produced an overall average of 63.8% positives in the candida-involved group, with 12.3% positives in the controls. In the individual tests, the best performance was shown by the CEP-3 test (92.5% positives in the candida-involved group and 2.1% positives in controls) and the CEP-1 test (88.7% positive in the candida-involved group and no positives in the controls). The tests with the highest sensitivity were the AGGL-2 and CEP-2 (94.3 and 96.2%, respectively). These tests were also the least specific (80.9 and 76.6%, respectively). In the three common tests, the AGD-1 was the most reproducible, whereas the AGGL-1 produced considerable laboratory-to-laboratory variation. Since cell-free extracts of mechanically disrupted C. albicans were used for the LAT and all the AGD and CEP tests, the difference in performance was considered to be mainly due to antigenic composition and the conditions of the test. The results of this study confirm the value of serological tests for the diagnosis of systemic candidiasis, but point out the need for standardized reagents.

Agglutination Tests↗
PubMed1986

The sensitivity of various serologic tests in the diagnosis of Rocky Mountain spotted fever.

Sensitivity indices for various serologic tests in the diagnosis of Rocky Mountain spotted fever (RMSF) were determined from RMSF surveillance data collected at the Centers for Disease Control (CDC) during 1981-1984. During these 4 years, a total of 4,141 cases of RMSF in the U.S. were reported to CDC. Case report forms, which include information on dates and results of serologic testing, were received for 3,567 of these cases; 1,774 were laboratory-confirmed according to criteria published previously by CDC. Sensitivity indices for the Weil-Felix (Proteus OX-19, OX-2), indirect fluorescent antibody (IFA), latex agglutination (LA), complement fixation (CF) and indirect hemagglutination (IHA) tests were examined by analyzing cases confirmed by other means, in which data concerning the test in question were available. Analysis of serum pairs for a 4-fold or greater increase in antibody titer or a minimum diagnostic titer indicated high sensitivity indices for IHA (96%) and IFA (94%), but lower sensitivity indices for OX-19 (70%), OX-2 (47%), CF (63%) and LA (71%). IFA and IHA appear to be the most sensitive serologic tests currently in use for the diagnosis of RMSF.

Agglutination Tests↗
PubMed1976

Parallel evaluation of serological tests applied in african trypanosomiasis: a WHO collaborative study.

Previously, the most commonly used serological tests for the indirect diagnosis of African trypanosomiasis were the indirect fluorescent antibody test, immunodiffusion test, and the determination of IgM levels in serum and cerebrospinal fluid. Recently, the capillary passive haemagglutination test and the enzyme-linked immunosorbent assay (ELISA) have been used in diagnosing trypanosomiasis. However, a parallel evaluation was needed to indicate the comparative diagnostic value of these various serological tests. A double-blind study conducted by WHO with the collaboration of three European and four African laboratories using well-documented serum samples provides a reasonable basis for determining in parallel the sensitivities of the various techniques.

Clinical Trials as Topic↗
PubMedDate not supplied

Validation of serological tests for Helicobacter pylori infection in an Irish population.

BACKGROUND: Serological tests for Helicobacter pylori using laboratory and 'office' formats are commonly used, easy to perform, inexpensive and widely available. Local validation of test performance is required. AIMS: This study examined the performance of a laboratory and 'office' ELISA in a population of Irish dyspeptics presenting for endoscopy. METHODS: Consecutive patients presenting for endoscopy had blood drawn at sedation. Samples were analysed using two ELISA formats; a standard laboratory format and an 'office' ELISA test card. H. pylori infection was diagnosed by analysis of antral and corpus biopsies using the rapid urease test, culture and histology. A combination of two positive invasive tests was considered indicative of infection. RESULTS: The sensitivity and specificity of laboratory ELISA was 82.4% and 85% respectively while the values for the 'office' ELISA were 87.7% and 85.7% respectively. In patients under 45 years sensitivities and specificities of the 'office' test exceeded 90%. The two serological tests agreed in 87.5% of subjects. CONCLUSIONS: Both tests performed satisfactorily. However, indeterminate results impaired the usefulness of the laboratory ELISA particularly when using a new cut-off. The 'office' ELISA performed particularly well in young patients. A simpler test using antigens from locally prevalent strains to optimise accuracy is awaited.

Enzyme-Linked Immunosorbent Assay↗