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Evaluation of a point-of-care immunodot assay for predicting results of allergen-specific intradermal and immunoglobulin E serological tests.

Immunotherapy to prevent recurrence of clinical signs of atopic dermatitis (AD) is based on intradermal or serological tests that assist in identifying allergen-specific immunoglobulin E hypersensitivities. Unfortunately, the results of such tests can be negatively influenced by several factors, which include the age of the patients, the season of testing and the administration of anti-allergic drugs. Screening to predict when these expensive tests will be useful would benefit owners of dogs with AD. The objectives of this study were to determine whether a point-of-care allergen-specific immunodot assay (Allercept E-Screen, Heska Corp., Ft Collins, CO, USA) could predict results of either intradermal or Allercept full panel serological tests in atopic dogs. Thirty dogs living in the south-eastern USA were diagnosed with AD in accordance with current standards. Allergen-specific intradermal, serological and E-Screen tests were performed in all subjects. For flea, house dust mite and pollen allergens altogether, results of the E-Screen assay agreed with those of intradermal and serological tests in 26/30 dogs (87%) and 25/30 dogs (83%), respectively. In this group of dogs, the probabilities of obtaining intradermal or serological tests positive for these allergens were 70 and 67%, respectively. If either skin or serum tests were performed only in dogs with positive E-Screen tests, the probability of obtaining positive results would be increased from 70 to 95% and from 67 to 90%, respectively. In this population of dogs with AD, results of the E-Screen point-of-care immunodot assay was found to often agree with those of allergen-specific intradermal or Allercept tests for selected allergen groups.

Allergens↗

Contribution of systematic serological testing in diagnosis of infective endocarditis.

Despite progress with diagnostic criteria, the type and timing of laboratory tests used to diagnose infective endocarditis (IE) have not been standardized. This is especially true with serological testing. Patients with suspected IE were evaluated by a standard diagnostic protocol. This protocol mandated an evaluation of the patients according to the modified Duke criteria and used a battery of laboratory investigations, including three sets of blood cultures and systematic serological testing for Coxiella burnetii, Bartonella spp., Aspergillus spp., Legionella pneumophila, and rheumatoid factor. In addition, cardiac valvular materials obtained at surgery were subjected to a comprehensive diagnostic evaluation, including PCR aimed at documenting the presence of fastidious organisms. The study included 1,998 suspected cases of IE seen over a 9-year period from April 1994 to December 2004 in Marseilles, France. They were evaluated prospectively. A total of 427 (21.4%) patients were diagnosed as having definite endocarditis. Possible endocarditis was diagnosed in 261 (13%) cases. The etiologic diagnosis was established in 397 (93%) cases by blood cultures, serological tests, and examination of the materials obtained from cardiac valves, respectively, in 348 (81.5%), 34 (8%), and 15 (3.5%) definite cases of IE. Concomitant infection with streptococci and C. burnetii was seen in two cases. The results of serological and rheumatoid factor evaluation reclassified 38 (8.9%) possible cases of IE as definite cases. Systematic serological testing improved the performance of the modified Duke criteria and was instrumental in establishing the etiologic diagnosis in 8% (34/427) cases of IE.

Antibodies, Bacterial↗

Comparison of the abilities of serologic tests to detect pseudorabies-infected pigs during the latent phase of infection.

OBJECTIVE: To compare the sensitivities of all available serologic tests in detecting pseudorabies virus (PRV) antibodies in pigs during long-term latent pseudorabies. DESIGN: Pigs experimentally infected with a virulent strain of PRV were maintained for 2 to 27 months after inoculation. At the time of necropsy of each pig, blood was collected for serologic evaluation, and tissues were obtained for polymerase chain reaction (PCR) verification of latency. ANIMALS: 65 crossbred pigs each weighing approximately 18 kg at the start of the study. PROCEDURE: Serum samples from each pig were analyzed by serum neutralization, latex agglutination, screening ELISA, particle concentration fluorescence immunoassay, automated latex agglutination, and differential ELISA for glycoproteins I, III, and X. DNA was extracted from the trigeminal ganglia and tonsils of each pig and was analyzed by PCR for PRV genomic sequences. RESULTS: PCR analysis of trigeminal ganglia and tonsils indicated that all pigs were latently infected with PRV at the time of necropsy, and serologic testing verified that all pigs had PRV-specific antibodies, regardless of duration of infection. The screening tests were virtually equivalent in sensitivity for detection of PRV antibodies. Of the differential serologic tests, the glycoprotein-I and -III marker systems, which performed with similar sensitivity as screening tests, were superior to the glycoprotein-X marker system in detecting PRV antibodies in latently infected pigs. CONCLUSION: Serologic testing consistently detects pigs in the latent phase of PRV infection, provided that the test detects the antibody response to the whole virus or to a reliable PRV-marker glycoprotein.

Animals↗

The utility of serologic testing for varicella in an adolescent population.

The purpose of this study was to determine what proportion of adolescents without a history of varicella are seropositive, and if serologic testing of this adolescent subpopulation is cost-effective. We identified 122 patients with 'no' or 'unknown' histories of chicken pox from our adolescent clinic. Of these, 58 (48%) were found to be Varicella Zoster Virus (VZV) seropositive. Cost to the government for batched serologic testing of all unknowns was $682.65, while each adolescent vaccinated cost $59.60. Serologic testing prior to routine immunization of adolescents with unclear varicella histories saved $2774.15 (38% of routine immunization costs). In this population, serologic testing is more cost effective than routinely immunizing all unknowns.

Adolescent↗

Cost-effectiveness of herpes simplex virus type 2 serologic testing and antiviral therapy in pregnancy.

OBJECTIVE: The purpose of this study was to determine whether serologic testing for herpes simplex virus type 2 (HSV-2) in pregnant women and their partners is cost-effective. STUDY DESIGN: A decision analysis model was developed to investigate the cost-effectiveness of providing type-specific serologic testing at week 15 of pregnancy for all women unaware of their HSV-2 status, and offering antiviral suppressive therapy from week 36 until delivery to all seropositive women. This scenario was compared with current care, in which only a minority of women diagnosed with genital herpes (GH) receives antiviral suppressive therapy (AST). In a third scenario, testing is offered to partners of pregnant women who test seronegative, and antiviral suppressive therapy is offered to the partners who test seropositive. RESULTS: Compared with current care, offering testing and antiviral suppressive therapy to 100,000 pregnant women resulted in an incremental cost of $3.1 million, 15.7 fewer cases of neonatal herpes, 186 fewer cesarean deliveries, and an incremental cost per quality-adjusted life- year gained (QALY) of $18,680. Offering testing and suppressive therapy to both the pregnant women and their partners resulted in an increased cost of $8.6 million, 16.8 fewer cases of neonatal herpes, 192 fewer cesarean deliveries, and an incremental cost per QALY of $48,946 compared with no testing. CONCLUSION: Compared with commonly accepted benchmarks for cost-effectiveness (<$50,000/QALY), type-specific HSV-2 serologic testing of pregnant women may be a cost-effective strategy.

Adolescent↗

Survey on testing criteria and reporting methods for human immunodeficiency virus serologic tests in Veterans Administration Medical Centers.

Guidelines for the indications for use, requirements for consent, and mechanisms for reporting of serologic tests for human immunodeficiency virus (HIV) infection are not standardized. In trying to establish such guidelines for our hospital, we surveyed all Veterans Administration Medical Centers regarding their current approach to testing both patients and employees. Infection control practitioners from 67 hospitals representing 37 states responded. Patients are likely to be tested for diverse reasons, unlikely to be counseled about the test or be required to consent to it, and test results are given no special precautions. Although 66% of the respondents do not use any extra precautions concerning patient confidentiality, 80% utilize more stringent criteria for testing and result-reporting with employees than patients. Thus, while the majority of hospitals maintain that current modes of confidentiality are acceptable for patients, practice suggests that these modes are considered inadequate for employees.

Acquired Immunodeficiency Syndrome↗

Development of a serological test for tuberculosis. Problems and potential.

The secreted antigens of 24K and 38K and the hsp of 12K and 16K are valuable as reagents in a serodiagnostic assay for tuberculosis. A combination of the TB72 assay with either the 16K or 24K antigen gives the best sensitivity and specificity. Antigens isolated from mycobacterial cultures are valuable in a serological test. Peptides cannot be used as antigens. The value of antigens obtained with recombinant DNA techniques remains to be determined. In HIV-seronegative patients with TB serodiagnosis is a valuable test both in pulmonary and extrapulmonary TB. Unfortunately, the results in HIV-seropositive patients are rather disappointing. The use of likelihood ratios seems to increase the potential of serodiagnostic assays. The value of serodiagnosis should be judged in context with other diagnostic methods such as direct microscopy, bacteriological culture or skin tests. A serological test is especially valuable in cases where direct microscopy, polymerase chain reaction or skin testing is negative and allows antituberculous therapy to be started before results of culture are known.

Antigens, Bacterial↗

Comparison of commercial serological tests for detection of Helicobacter pylori antibodies.

Serological testing for Helicobacter pylori infection is one of the diagnostic methods of choice. Various commercial kits that use different antigens have been developed, but data on their diagnostic accuracy and direct comparisons between the tests are lacking. We aimed to evaluate the sensitivity, specificity, and predictive value of three immunoglobulin G enzyme-linked immunosorbent assay kits: Pylori stat, Helico-G, and Premier H. pylori. Serum samples and gastric biopsy findings from 76 patients were evaluated. We found by using a priori cutoff values that the Pylori stat, Helico-G, and Premier kits had overall sensitivities of 96, 96, and 88%, respectively, and specificities of 94, 86, and 96%, respectively, compared with gastric biopsy findings. For 232 serum samples, the Pylori stat test and a previously validated standard serological assay on which the test was based disagreed in 3% of the cases, while for 76 samples that were tested, Helico-G and a previously validated standard assay on which it was based disagreed in 8% of the cases. The intra- and interassay precision of each of the test kits was high. We conclude that serology based on any of these commercial tests represents a reliable and valid method for the diagnosis of H. pylori whether or not highly purified antigens are used.

Adolescent↗

Sensitivity and specificity of various serologic tests for detection of Toxoplasma gondii infection in naturally infected sows.

The sensitivity and specificity of various serologic tests for antibodies to Toxoplasma gondii were compared in 1,000 naturally exposed sows, using isolation of viable T gondii as the definitive test. Serum samples obtained from heart blood of 1,000 sows from Iowa were examined for T gondii antibodies by use of the modified agglutination test (MAT), latex agglutination test (LAT), indirect hemagglutination test (IHAT), and ELISA. Toxoplasma gondii was isolated from 170 hearts of 1,000 sows by bioassays in mice and cats. The percentage of samples diagnosed as positive for each of the serologic tests was: MAT = 22.2% (titer > or = 1:20), IHAT = 6.4% (titer > or = 1:64), LAT = 10.4% (titer > or = 1:64), and ELISA = 24.1% (OD > 0.360). The sensitivity and specificity of these tests were calculated respectively to be: 82.9 and 90.29% for MAT, 29.4 and 98.3% for IHAT, 45.9 and 96.9% for LAT, and 72.9 and 85.9% for ELISA. The dye test was run at 1:20 dilution on only 893 sera because of bacterial contamination and presence of anticomplement substances. Dye test antibodies were found in 17.8% of the sera, and sensitivity and specificity were 54.4 and 90.8%, respectively. Thus, the MAT had the highest sensitivity among all serologic tests used.

Agglutination Tests↗

Efficacy of serologic testing in asymmetric sensorineural hearing loss.

PURPOSE: The goal of this study was to determine the efficacy of a detailed questionnaire, auditory brain stem response testing (ABR), MRI, and an extensive battery of serologic tests in diagnosing asymmetric sensorineural hearing loss (ASNHL). METHODS AND MATERIAL: Patients with audiograms demonstrating ASNHL of 10 dB or greater in 2 consecutive frequencies or 15 dB in any 1 frequency between 250 and 6000 Hz were asked to participate. Patients underwent MRI scanning of the cerebellopontine angle, internal auditory canals, and posterior fossa with gadolinium contrast, ABR, and an extensive battery of tests. The causative diagnosis was made by the individual clinician based on each patient's history, physical examination, and test results. RESULTS: Forty-five patients completed the study. A review of the data confirmed the utility of a detailed history and physical examination, MRI, and fluorescent treponemal antibody test in all cases. Erythrocyte sedimentation rate, glycosylated hemoglobin, Lyme antibody titers, and total hemolytic component (CH50) were helpful in selected cases. Thyroid function testing, complete blood count, Sequential Multiple Analysis-7, prothrombin time/partial thromboplastin time, lipid profile, and ABR were of no value in these patients. CONCLUSION: A careful history and physical examination, MRI, and fluorescent treponemal antibody test should be performed for the evaluation of all patients with ASNHL; however, more extensive serologic testing, including sedimentation rate, glycosylated hemoglobin, Lyme antibody titers, and CH50, should be selectively performed, based on a suggestive history or suspicious physical findings.

Adult↗

Serological testing for herpes simplex virus (HSV)-1 and HSV-2 infection.

Serological tests for herpes simplex virus (HSV) that can accurately distinguish between HSV-1 and HSV-2 are now commercially available. These tests detect antibodies to HSV glycoproteins G-1 and G-2, which evoke a type-specific antibody response. Focus Technologies produces the HerpeSelect-1 and HerpeSelect-2 enzyme-linked immunosorbent assay tests and the HSV-1 and HSV-2 HerpeSelect1/2 Immunoblot. Diagnology has marketed POCkit-HSV-2, a point-of-care test for HSV-2 that allows blood from a finger stick to be tested in a clinic. These tests can be used to confirm a genital herpes diagnosis, establish diagnosis of HSV infection in patients with atypical complaints, identify asymptomatic carriers, and identify persons at risk for acquiring HSV. Potential settings for use of these tests include sexually transmitted disease clinics, prenatal clinics, and clinics that care for patients with human immunodeficiency virus. Patient interest in HSV serological tests appears high.

HIV Infections↗

Comparison of three serological tests in gonococcal infection.

Three serological tests used in the diagnosis of gonococcal infection were compared with cultural techniques in 857 females attending the Prenatal and Gynaecology Clinics at the Winnipeg General Hospital. The tests evaluated were the microflocculation technique (MFT), the indirect fluorescent-antibody technique (IFAT), and the complement-fixation technique (CFT). One hundred six patients had positive cultures for Neisseria gonorrhoeae. In this population, the MFT was reactive in 80 patients (75.4%), the IFAT was reactive in 74 (69.8%), and the CFT was reactive in 33 (31.1%). In the 751 patients with negative cultures, the MFT was positive in 11.4%, the IFAT was positive in 17.4%, and the CFT was positive in 10.5%. Sera from 9 of 10 patients with gonococcal arthritis were positive with the MFT.

Adolescent↗

False-positive serological tests in acute malaria.

A range of serological tests, including rapid plasma reagin (RPR), Widal test, enzyme-linked immunosorbent assay (ELISA) for human immunodeficiency virus (HIV)-1 and -2, direct Coombs' test (DCT), and rheumatoid factor (RF) were performed in a well-characterised cohort of 100 patients with acute malaria (Plasmodium vivax infection: 31 patients; P. falciparum infection: 69 patients). Twenty-five healthy volunteers from a similar area were used as controls. Three patients from the severe P. falciparum group died, the remainder of the patients recovered completely. A large proportion of these patients showed false-positive serological reactions during the acute stage of infection, which became negative on re-testing, four weeks after recovery. In tropical countries such as India, where malaria is endemic, results of serological tests should be interpreted with caution in a patient with pyrexia of unknown origin (PUO).

AIDS Serodiagnosis↗

Evaluation of different turkey rhinotracheitis viruses used as antigens for serological testing following live vaccination and challenge.

Two enzyme-linked immunosorbent assays (ELISA) developed in the authors' laboratory for turkey rhinotracheitis serological testing, a commercial ELISA kit, and two virus-neutralization (VN) assays were compared with respect to the efficiency of these assays for serological monitoring in specific-pathogen-free (SPF) turkeys inoculated with four pathogenic isolates of turkey rhinotracheitis virus, with or without previous live vaccination. Both the live vaccine and the different isolates of virus were shown to induce antibody rises, the detectability of which varied depending on the ELISA or VN assay used for serological testing. The results show that 3 weeks after vaccination with an attenuated strain, the choice of an inadequate antigen for serological testing may be the cause of an apparent lack of immunogenicity of the vaccine, and that 2 weeks after challenge, such a choice in ELISA can also hinder the early diagnosis of a TRT virus infection in both vaccinated and unvaccinated turkeys.

Animals↗

[Electrocardiographic changes in 29 apparently healthy subjects with positive serological tests for Chagas disease].

Of 78 apparently healthy subjects with positive serological tests for Chagas disease, 29 had EKG abnormalities. On direct questioning only two referred dyspnea, one had palpitations and another one dizziness. The most frequent EKG abnormalities were: peaked T waves in 10 cases; ventricular premature beats in 8 patients, right bundle branch block in 7, left bundle branch block in 5, abnormal ST-T segment in 4, atrial fibrillation in 3 cases, left ventricular hypertrophy in 3, and left anterior hemiblock in 3. As has been previously recognized, the EKG changes plus the positive serological tests are the earliest manifestations of Chagas disease.

Adolescent↗

Routine serologic tests in the differential diagnosis of the adult nephrotic syndrome.

From 1980 to 1985, we performed biopsies on 87 adults with nephrotic syndrome (NS). The patients were tested for whether serologic studies obtained routinely at biopsy added to clinical diagnostic accuracy. Using history, physical examination, complete blood cell count (CBC), chemistry panel, urinalysis, and urine creatinine and protein, four nephrologists each predicted whether the patient had primary NS (PNS) or secondary NS (SNS), and the most likely histopathologic entity. Six months later, each nephrologist used this information, with results of tests of sera for fluorescent antinuclear antibody (FANA), rheumatoid factor (RF), complement components, hepatitis B surface antigen (HBsAg), venereal disease research laboratory serology (VDRI), cryoglobulins and protein electrophoresis (SPEP), with an erythrocyte sedimentation rate (ESR) and protein electrophoresis of the urine (UPEP), to make identical predictions. Histopathology was established by renal biopsy. We analyzed the concordance between nephrologists' choices and biopsy results both before and after serologic tests were available with a kappa statistic. Preserology concordance was moderate (kappa = 0.52), and identical to postserology concordance (kappa = 0.51) for both PNS versus SNS and actual histopathology. Serologies were rarely abnormal without clinical suspicion. These results suggest routine serologic testing does not improve diagnostic accuracy in adult NS.

Adult↗

Optimizing typhoid fever case definitions by combining serological tests in a large population study in Hechi City, China.

Blood culture-based diagnosis can only detect a fraction of the total burden of Salmonella enterica subsp. enterica serovar Typhi. The objective of the study was to detect additional typhoid fever cases through serological tests. A total of 1732 prolonged fever episodes were evaluated using three serological tests, Widal, Tubex and Typhidot-M in a typhoid fever endemic area of southern China. A case definition which included a positive Widal test (TO>or=80 & TH>A), a positive Tubex test (>or=4) and a positive Typhidot-M test, increased the detection of cases by more than twofold from 13 to 28 cases. The case definition has a specificity of 100% and a sensitivity of 39%. Case definitions based on combinations of serological tests can detect additional typhoid fever cases with higher specificity than a single serological test. Improved case detection is essential to understand the true disease burden and can help to boost the power of intervention trials.

Adolescent↗

The diagnostic accuracy of serologic tests for celiac disease: a systematic review.

Clinicians are increasingly utilizing noninvasive serologic tests for the diagnosis and screening of celiac disease (CD). The aim of this study was to conduct a systematic review of the diagnostic performance of serologic tests for the diagnosis and screening of CD. Standard systematic review methodology was used. A literature search was conducted in MEDLINE (1966 to October 2003) and EMBASE (1974 to December 2003) databases. A weighted mean of the sensitivity and specificity along with 95% confidence intervals and summary receiver operating characteristic (ROC) curves were calculated. The pooled specificity of endomyseal antibody (EMA)-monkey esophagus (ME) or EMA-human umbilical cord (HU) was close to 100% in adults and children. The pooled specificity of transglutaminase antibody (tTG)-guinea pig (GP) and tTG-human recombinant (HR) were between 95% and 99%. IgA-EMA-ME demonstrated sensitivities of 96% and 97% in children and adults, respectively. EMA-HU demonstrated a similar sensitivity of 97% in children but 90% in adults. The pooled sensitivity of tTG-GP in adults and children was 90% and 93%, respectively. The sensitivity of tTG-HR was 98% and 96%, respectively. The performance of antigliadin antibody was inferior to that of EMA and tTG. EMA and tTG offer high sensitivity and specificity. The sensitivity of these tests appears to be lower than reported when milder histologic grades are used to define CD (below 90%). If true, the nearly perfect negative predictive value of these tests would drop. The positive predictive value of these tests is likely lower than reported when the tests are applied in low-prevalence populations.

Antibodies↗