The clinical significance of hyperglobulinemia. II. Correlation with liver function tests, serologic tests for syphilis, and bone marrow examinations.
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Serologic testing is a useful noninvasive testing strategy for H. pylori. It is particularly useful in areas where the prevalence of H. pylori is high and inexpensive point-of-contact fingerprick tests are used. Sensitive tests are valuable ways of excluding H. pylori infection and can be used in conjunction with a direct test (urease histology culture or breath test) to confirm absence of H. pylori if the two methods are concordant. Serologic testing is more definitive and differentiating if the antigenic epitopes of H. pylori can be differentiated based on the antigenic epitopes that specifically associate with gastric cancer, peptic ulcer, and nonulcer dyspepsia. A study by Kawahara's group reported that Hsp 60 may be involved in the development of mucosa-associated lymphoid tissue based on ELISA. The idea of differentiating antigens for H. pylori may open a new area for use of serologic testing in the diagnostic approach of H. pylori infections.
Serologic testing for the presence of antibodies to Bartonella henselae is a widely accepted diagnostic procedure for laboratory confirmation of the diagnosis of cat scratch disease (CSD). In this study a commercially available indirect immunofluorescence assay (IFA) based on B. henselae-infected human larynx carcinoma cells (test A) was evaluated. Sera from 42 patients with CSD (20 confirmed by PCR) and 270 sera from healthy controls (consisting of 63 cat owners, 65 individuals whose last close contact with cats was >6 months previously, and 142 persons who had never been exposed to cats) were investigated for antibodies to B. henselae. All patients with CSD had titers of immunoglobulin G (IgG) to B. henselae of 128 or higher (test A; sensitivity, 100%). Of the 270 controls 189 (70%) were seronegative (titer, <64), 38 (14.1%) had titers of 64, 30 (11.1%) had titers of 128, 9 (3.3%) had titers of 256, and 4 (1.5%) had high titers, 512 (test A; specificity, 70%). Of the cat owners and individuals who had never had close contact with cats, 71.4 and 71.12%, respectively, were seronegative, and titers of 64, 128, 256, and 512 were found in 14.3 and 16.2%, 1.6 and 10.5%, 9.5 and 0.7%, and 3.2 and 1.4%, respectively. The sera from the patients and from the first 100 healthy adults without a history of close contact with cats were additionally tested with a second commercially available IFA, based on Vero cells infected with B. henselae and Bartonella quintana (test B). The sensitivity and specificity of test B were 93 and 73%, respectively. For patients with CSD the cross-reactivity between B. henselae and B. quintana in this test was 95%. Both systems are highly sensitive but less specific for detection of IgG antibodies to B. henselae in samples from patients with clinically apparent CSD. For detection of IgM antibodies, test A seems to be more sensitive (88%) and more specific (95%) than test B (sensitivity and specificity of 64 and 86%, respectively). The data show that the seroprevalence of antibodies to B. henselae in German individuals is high (30%). Low antibody levels are not sufficient evidence of active or prior infection.
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Serologic techniques for the detection of antibodies to rubella virus provide the approach of choice for laboratory diagnosis of acute and congenital rubella infections and for the determination of rubella immunity status. Rubella serodiagnostic tests currently being used in clinical laboratories are described in this review. Advantages, limitations, and relative sensitivities and specificities of these tests are presented. The reactivity and specificity of rubella antibody tests have been shown to vary from laboratory to laboratory and from one manufacturer's kit to another. The need is clearly apparent for a universally accepted reference standard that will allow sensitivities and alternative assays to be compared directly and a meaningful immune cutoff level to be established. Incorporating such standards into the available rubella tests would eliminate much of the diagnostic uncertainty associated with rubella infections during pregnancy.
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The current potency test for pertussis vaccines, the mouse protection test (MPT), has many disadvantages. However, no alternative is yet available. The purpose of this study is to develop a serological alternative for the MPT based on in vitro assessment of the humoral immune response against pertussis in mice. After immunization with pertussis whole cell vaccine, the MPT shows a normal primary and secondary antibody response. Moreover, the i.c. challenge has a distinct booster effect on the pertussis IgG response. The relationship between the concentration of IgG antibodies against the surface-antigens of pertussis bacteria and the survival of mice after the i.c. challenge was demonstrated in a modified MPT (R = 0.91). To this end a protecting antibody level of > or = 45 EU/ml was selected as a level at which concentration most of the mice survived. Survival of mice in the MPT could be predicted, based on the antibody concentration at the day of challenge. Potencies estimated with the predicted and actual survival corresponded well (P = 0.990). This confirmed the essential role of vaccine induced pertussis antibodies in the protection against a lethal i.c. challenge and offered a possibility to develop a pertussis potency test based on serology. We developed a model in which mice (20-24 g) are immunized (i.p.) with graded doses of vaccine and bled after four weeks. Sera are titrated in Bordetella pertussis whole cell ELISA and potency based on vaccine dose dependent antibody response is estimated by means of a parallel line analysis. The potency of vaccines tested in the Pertussis Serological Potency Test (PSPT) and MPT are significantly similar, a P-value of 0.92 was found by means of the chi 2 test. Compared to the MPT, the PSPT is more reproducible as is indicated by its smaller 95% confidence intervals. Moreover, by using the PSPT the animal distress can be reduced to an acceptable level and the PSPT also results in a reduction of more than 25% in use of mice.
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For many years it has been the practice in Brazil to question donors and to test blood to be used in blood banks for HIV, Chagas' disease, hepatitis B and C, and syphilis. Counseling and blood testing programs have recently been established to assist in identifying and treating those with HIV. In a blood bank center in Campo Grande, Mato Grosso do Sul State (MS), we evaluated the frequency and age of patients with positive tests for T.cruzi in order to determine whether the frequency and age distribution indicated that this infection should be added to the counseling and testing programs. A group of 476 first time blood donors were enrolled to answer a questionnaire and to be tested serologically for Chagas' disease, HIV, hepatitis B and C, and syphilis. A standard ELISA and an IFA test were used for Chagas' disease patients. Five patients (1.1%) were serologically positive for T.cruzi infection. All five were male between 22 and 35 years of age. None of the five had been born in Mato Grosso do Sul State. Four donors donated blood in order to obtain serologic test results, only one donated blood as a social responsibility. One was HIV positive and related previous STD, and one had received a blood transfusion between 1980 and 1986. Each had had only one sexual partner in the last six months. The age range and the frequency of 1.1% suggest that it would be beneficial to include this disease in counseling and testing program in Brazil. The limitations of this approach are the relatively low attendance at such centers in Mato Grosso do Sul (1.7 people/day compared to a national average of 2.9 people/day), the slow reporting time for results (1 week compared to 1 day for the blood bank reporting), and the absence of a standard disease-specific testing procedure. We recommend increasing the use of serologic tests for T.cruzi and designing appropriate questionnaires in counseling and testing programs now used primarily for HIV, assuming the existing limitations can be overcome.
Serological testing is a common method of diagnosis of felina viral infections, including feline immunodeficiency virus (FIV), feline leukemia virus (FeLV), and feline infectious peritonitis virus (FIPV). Infections with these viruses can be difficult to diagnose by clinical signs alone and are sometimes clinically inapparent for months after initial exposure. Serological testing to confirm a tentative diagnosis or as a screening tool for infection can be invaluable. However, serological tests must be used only with a thorough understanding of the mechanisms and abilities of the tests, and with recognition of their potential inadequacies and misinterpretations. This report summarizes the assays available for FIV, FeLV, and FIPV, and discusses merits and pitfalls associated with each test.
OBJECTIVE: The best way to test serologically for coeliac disease (CD) remains controversial, with endomysial (EMA), transglutaminase (TTG), and gliadin antibodies (AGA) being assessed in various combinations with no apparent standardization. The objective of this study was to evaluate whether TTG-IgA+/-TTG-IgG could be used as a replacement for endomysial antibodies as a reliable screen for CD in patients presenting to a major Australian tertiary referral hospital for assessment of symptoms consistent with CD. METHODS: Individuals referred for gastroscopic assessment of possible CD were prospectively evaluated by duodenal biopsy assessment. The following diagnostic methods were compared: dual-isotype transglutaminase (TTG-dual), combined-isotype transglutaminase (TTG-IgA+G), TTG-IgA, combined-isotype gliadin antibodies (AGA-IgA+G), AGA-IgA, and endomysial antibody assays. Clinical performance characteristics (sensitivity, specificity, area under the curve for receiver-operating characteristic analysis; AUROC) were assessed for all kits. RESULTS: The correlation between transglutaminase kits was generally good, with the best transglutaminase kit demonstrating high correlation (r=0.86) with endomysial antibodies. A comparison of different types of endomysial antibody assays displayed variable diagnostic performance (sensitivity 61.90-68.42%; specificity 80.00-98.57%; AUROC 0.71-0.83). Sensitivity (90.48-92.31%), specificity (80.77-82.89%) and AUROC values (0.92-0.94) for dual-isotype transglutaminase kits displayed narrow ranges. AGA assays were less sensitive (AGA-IgA: 42.31-46.15%; AGA-IgG: 61.54%) and less specific (AGA-IgA: 85.09-87.73%; AGA-IgG: 82.46-84.09%). Dual-isotype transglutaminase testing was diagnostically equivalent to transglutaminase-IgA (AUROC 0.92 versus 0.91, P=0.33). CONCLUSIONS: Our study suggests that transglutaminase screening (using the IgA+/-IgG isotype) is a sensitive and specific alternative to endomysial antibody testing in the serological assessment of CD. On the basis of our findings, AGA antibody testing no longer appears to be an essential part of the diagnostic strategy for adult CD.
Serum antibody detection tests and a urine antigen detection technique were compared in samples from 116 patients epidemiologically characterized as belonging to a legionellosis outbreak. Sera were tested by enzyme-linked immunosorbent assays (ELISAs) for immunoglobulin M (IgM) and IgG plus IgM and by immunofluorescent assays (IFAs) for IgG, IgM, IgA, and polyimmunoglobulin using commercial kits (Vircell); concentrated urines were tested with the Binax NOW Legionella test. ELISA for IgM, ELISA for IgG plus IgM, antigenuria detection, and IFA for IgM were able to diagnose 72.3%, 60.5%, 53.3%, and 51.4%, respectively, of patients. Antigenuria was present in 53.8% of first samples, ELISA detected IgM in 29.7%, ELISA detected IgG plus IgM in 7.9%, and IFA detected IgM in 3.9%. Ten antigenuria-negative first samples tested serologically positive, 9 of them to IgM by ELISA. Despite the single source of the samples included in the study, detection of IgM using a sensitive technique such as ELISA seems to be a suitable complement to antigenuria detection for the diagnosis of legionellosis.
OBJECTIVE: Antibody testing is the recommended method to screen for Helicobacter pylori (H. pylori) infection. Whole-blood fingerstick antibody tests are simple, in-office tests providing rapid results, but the accuracy of first-generation tests was lower than other diagnostic tests. We assessed a new whole-blood antibody test, using endoscopic biopsy tests as a "gold standard," and compared it with a laboratory quantitative serological test. METHODS: Two hundred-one patients not previously treated for H. pylori who were undergoing endoscopy had gastric biopsies for rapid urease test and histological examination; whole-blood antibody tests and quantitative serological tests were also performed. Two separate gold standards for H. pylori infection were employed: either rapid urease test or histological exam positive; and both rapid urease test and histological exam positive. RESULTS: Sensitivities for whole-blood test versus quantitative serology with gold standard 1 (either biopsy test positive) were 86% versus 92% (95% confidence interval [CI] of difference, -2-14%; p = 0.19) and specificities were 88% versus 77% (95% CI of difference, 0.4-22%; p = 0.052). Sensitivities with gold standard 2 (both biopsy tests positive) were 90% versus 94% (95% CI of difference, -4-12%; p = 0.41) and specificities were 79% versus 67% (95% CI of difference, 1-24%; p = 0.048). CONCLUSIONS: New generation in-office, whole-blood antibody tests that can achieve a sensitivity and specificity similar to or better than those of widely used quantitative laboratory serological tests may be used as the initial screening tests of choice for H. pylori.
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