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Home collection versus publicly funded HIV testing in San Francisco: who tests where?

We examined records of all HIV antibody tests performed at anonymous publicly funded (PF) sites and by home collection (HC) testing for residents of San Francisco from August 1996 to December 1997. Although far fewer tests were performed by HC testing than at PF sites (715 versus 8712, respectively), a higher proportion of HC testers reported no prior history of HIV testing (33.1% versus 17.9%). HIV seroprevalence was higher among PF tests (1.8%) than among HC tests (0.9%). Compared with PF testers, HC testers were less likely to be gay men, lesbian or bisexual women, heterosexual women, African American, or Latino. HC testers were more likely to report sex with a known HIV-positive partner. HC testers were also more likely to reside in affluent neighborhoods. HC testing reaches some high-risk persons who may not otherwise seek PF testing, although, overall, the risk profile of HC testers appeared lower than that of PF testers. HC testing reaches some individuals who can financially afford HC testing, thus saving public prevention resources for hard-to-reach, high-risk populations.

AIDS Serodiagnosis↗

Replacement of the Toxin Neutralisation Test in Mice by in vitro Serological Assay Systems for Potency Testing of Tetanus Toxoid Vaccines for Veterinary Use: Results of a European Collaborative Study.

This paper describes the results of a collaborative study to the use of in vitro serological assay systems in the assessment of the potency of tetanus toxoid in single and multicomponent vaccines for veterinary use. According to the procedure described in monograph 697 of the European Pharmacopoeia (method A) these products are currently tested by toxin neutralisation tests in mice. The collaborative study was performed in seven laboratories throughout Europe. Nine commercial vaccines, representing the range of products available, and one experimental tetanus toxoid preparation were tested by immunisation of groups of rabbits and guinea pigs. Individual and pooled serum samples were titrated for levels of tetanus antitoxin by indirect enzyme-linked immunosorbent assay (ELISA), bowin binding inhibition (ToBI) test, passive haemagglutination (HA) test and by the toxin neutralisation (TN) test in mice. It was found that estimates of potency by in vitro tests and by the TN test were in good agreement for the various vaccines tested and for antitoxin titres of individual serum samples. Significant interlaboratory variation occurred less frequently for ELISA and ToBI than for HA. The frequency of significant interlaboratory variation was acceptable for ELISA and for ToBI but larger variation was observed for HA. It is concluded that ELISA and ToBI are suitable in vitro assay systems for assessing the potency of tetanus toxoid in batches of single and multicomponent vaccines for veterinary use. Rigid standardisation of HA test is essential before this test can be used for the same quality control purpose.

Journal Article↗

[Evaluation and comparison of the Helicobacter pylori stool antigen test and the gastric mucosal antigen test].

OBJECTIVE: To evaluate the reliability of an enzyme-linked immunosorbent assay by the Helicobacter pylori (H. pylori) stool antigen test for the detection of H. pylori infection. METHODS: Stool specimens were collected from 224 patients who received upper gastrointestinal endoscopic examination for gastrointestinal symptoms. H. pylori status was evaluated by five different tests: culture, histology, biopsy rapid urease test, H. pylori stool antigen test, and H. pylori gastric active mucosal antigen test (parts of the patients). A commercial kit using an enzyme-linked immunosorbent assay was used to examined H. pylori antigen in the stool or in the gastric active mucosa. H. pylori status was defined as positive when two of the three tests (culture, histology and biopsy rapid urease test) were positive. RESULTS: 137 patients were diagnosed as H. pylori-positive. The H. pylori stool antigen test was positive in 143 patients and negative in 81 patients. The sensitivity and specificity were 96.4% and 87.4%, respectively. The overall accuracy was 92.9%. 39 patients were examined H. pylori antigen in the gastric active mucosa, and 27/39 were diagnosed as H. pylori-positive. The H. pylori gastric active mucosal antigen test was positive in 28 patients and negative in 11 patients. The H. pylori stool antigen test was positive in 30 patients and negative in 9 patients. The corresponding rate between gastric active mucosa and stool was 94.9%. CONCLUSION: The H. pylori stool antigen test is a simple, non-invasive method for accurate diagnosis of H. pylori infection.

Adolescent↗

Gastric juice urease test and brushing urease test for Helicobacter pylori detection.

The aim of the study was to demonstrate the sensitivity, specificity and accuracy of gastric juice urease test and brushing-urease test compared to the biopsy-urease test for Helicobacter pylori (H. pylori) detection. For each patient, two milliliters of gastric juice was collected and one milliliter in the supernatant was tested for rapid urease reactions. One gastric mucus brushing and two biopsies were taken from the body and the antrum. The brushing specimens were tested for rapid urease reaction by shaking the brush into the urea broth. The gold standards for diagnosing of H. pylori are positive H. pylori upon specimen culture or positive identification of H. pylori from polymerase chain reaction (PCR) assay using primer for vac A gene. Forty patients were enrolled in the study including ten patients with gastric ulcer, six patients with duodenal ulcer and twenty four patients with non-ulcer dyspepsia. Brushing-urease test and biopsy-urease test were not different sensitivity (87.50% vs 93.20%), specificity (100% vs 100%) and accuracy (90.25% vs 95.50%). The gastric juice urease test had a sensitivity of 65.25 per cent, specificity of 100 per cent and accuracy of 75 per cent for detecting of H. pylori infection. In conclusion, gastric juice urease test had low sensitivity in the diagnosis of H. pylori infection. Brushing-urease test is as accurate as biopsy-urease test in detecting H. pylori infection. However, the brushing method had lower gastric tissue injury than the biopsy and so should be used for detecting H. pylori infection in patients with coagulopathy.

Adult↗

Prevalence of PSA testing and effect of clinical indications on patterns of PSA testing in a population-based sample of Alberta men.

An age-stratified population-based random digit dial (RDD) telephone survey determined awareness and prevalence of prostate-specific antigen (PSA) testing among Alberta men aged 40 74 years, and assessed the role of indications for PSA testing in explaining patterns of PSA testing. The sample of 1984 men (participation rate 65%) with no history of prostate cancer was divided into three age strata: 40-49, 50-59, and 60-74 years. Awareness of PSA tests was low with fewer than half of the men indicating they had ever heard of PSA tests. The percentage of men who had ever had PSA testing was 4.5%, 13.1%, and 22.2% in the three age strata respectively. PSA testing was strongly associated with having at least one clinical indication for PSA testing (prevalence 21.8%, 26.9%, and 42.2% respectively). PSA testing rates were very low among men who had no clinical indications for PSA testing, suggesting infrequent PSA screening prior to the survey. PSA testing patterns in this population-based sample were consistent with Alberta clinical practice guidelines.

Adult↗

More enlightenment on the essence of applying Fisher's Exact test when testing for statistical significance using small sample data presented in a 2 x 2 table.

The paper illustrates the inconsistent behaviour of the Chi-Square test when applied onto 2 x 2 tables involving independent samples and a small overall sample size. The appropriateness of applying this test to a given 2 x 2 table was judged by the degree of agreement between the probability associated with a value of Chi-Square for that table and that obtained by direct application of Fisher's Exact Test. Data from two different studies were used for the illustration. For one of the tables, the two tests led to divergent conclusions about the Null Hypothesis (H degrees) being tested; and the two probabilities were found to differ quite significantly. When the same procedures were repeated for the data in another 2 x 2 table (also involving a small sample size) the two tests led to the same conclusion about Ho; and in this latter case, the two probabilities were approximately equal: thus implying good approximate accuracy of the Chi-Square test relative to the Exact Test. To avoid these unantisipated variations of results from the Chi-Square test when it is applied onto 2 x 2 tables involving small sample sizes, Fisher's Exact Test is further recommended as a definitive test, always to be resorted to for fourfold tables involving small sample sizes and independent samples.

Chi-Square Distribution↗

Diagnostic efficacy of stool antigen test (HPSA), CLO test and serology for the detection of Helicobacter pylori infection.

BACKGROUND: The diagnosis of Helicobacter pylori infection was initially being made through invasive methods but now non invasive methods have been developed to make the diagnosis easier. The present study was done to evaluate the diagnostic efficacy of a two non invasive tests i.e. Helicobacter pylori Stool antigen test (HpSA) and Helicobacter pylori IgG serology with an invasive method i.e. Campylobacter like organism (CLO) gel test. METHODS: The study was conducted in the gastroenterology unit of Pakistan Medical Research Council Research Centre Karachi. Adult patients with gastroduodenal disease were selected for study and their medical history was recorded. Endoscopy was done on all patients and the antral biopsy sample was tested for H. pylori using CLO test. Serology (IgG) was done elsewhere using ELISA and titers of over 50 units were recorded as positive. HpSA was done to determine the presence of H. pylori antigen in stool. RESULTS: Out of 43 patients 34 (79%) were males and 9 (21%) females. The main presenting symptom was epigastric pain in 74% cases. Although H. pylori IgG antibody titers of over 50 were taken as positive but for this study titres of over 100 were taken as significant for comparison with other tests. CLO test was positive in 26 (60.5%) cases, H. Pylori antibody titers of over 100 IU were present in 33 (76.7%) cases and HpSA in 21 (48.8%). Using CLO test as the gold standard the sensitivity of serology was 81% and that of HpSA 65% with a 29% and 76% specificity respectively. CONCLUSION: In our setting CLO test is still the best diagnostic test for H. Pylori detection. Both non invasive tests i.e. serology and stool HpSA are less sensitive than CLO but amongst each other both are equally sensitive.

Adult↗

Implementation of gel column technology, including comparative testing of Ortho ID-MTS with standard polyethylene glycol tube tests.

With the intent to increase laboratory efficiency and according to the Clinical Laboratory Improvement Act of 1988 (CLIA '88), a parallel testing program comparing traditional tube technology with the gel system technology was undertaken. Test tube indirect antiglobulin tests were performed using polyethylene glycol (PEG) as the antibody enhancement medium. Gel (GEL) column technology used the ID-Micro Typing System, using predispensed anti-IgG and low-ionic- strength saline for antibody enhancement. Tests were performed as described in the manufacturer's guidelines and the current edition of the Technical Manual of the American Association of Blood Banks. Testing included antibody detection, antibody identification, direct antiglobulin tests (DATs), antigen phenotyping (K, Fya, Fyb, S, and s), and elution studies. These procedures were evaluated for sensitivity, specificity, and efficiency. Sixty-six samples that had been tested for antibody activity by PEG tube techniques were evaluated by GEL. These samples included 49 that were nonreactive and 17 with a positive antibody detection test. Within the latter were 19 antibodies, 17 with specificities considered to be clinically significant and 2 usually considered clinically insignificant for red cell transfusion. GEL was nonreactive with the 49 PEG negative samples as well as with the 2 samples containing insignificant antibody. All 17 antibodies of probable clinical significance were detected. Antibody identification studies were performed on these latter samples, with GEL results consistent with PEG tube results in all cases. Concordant results were obtained with 10 of 10 DATs (7 negative, 3 positive), all 77 antigen phenotyping tests (37 negative, 40 positive), and the 6 parallel elution studies (4 negative, 2 positive). GEL testing was found to be comparable or better when compared with PEG tube testing in all procedures evaluated.

Journal Article↗

[Postponed or canceled drug challenge tests and side effects of the test drug--a report of four cases].

Drug challenge test (DCT) is performed to evaluate chronic pain pharmacologically and determine its medical treatment. One test drug is administered in one day for DCT and characterization of the test drug. Four patients developed side effects of the test drugs for DCT in whom other drug tests were postponed or canceled. A 58-year-old man with multiple arthritis of rheumatic arthritis and fibromyalgia had headache, nausea, and vomiting all day after ketamine test. A 76-year-old man with chronic general pain and failed back surgery syndrome had vomiting and abdominal discomfort two hours after morphine test and had redness and itching on his bilateral forearms the following day. A 78-year-old man with chronic lumbar and right lower limb pain due to L 4-5 lumbar disc herniation and postherpetic neuralgia felt dizzy, fell down and bruised on his lower back and left knee twelve hours after morphine test. A 32-year-old woman with chronic pelvic pain had skin eruption on her thigh the day after phentolamine test. Although the amount of the test drug in DCT is small and its half-life is short, long-term side effects might occur. We should decrease the amounts or frequencies of ketamine and morphine, and administer them taking long intervals before other tests.

Adult↗

[Dependence of microbiologic test results of formaldehyde gas sterilization methods on the nature of the test material].

The efficiency of a formaldehyde gas sterilization procedure was evaluated with the aid of test pieces consisting of various materials. Both rigid and flexible tubes served as test pieces. The tubes were 75 cm long with an inner diameter of 1 mm and were sealed at one end. The bioindicators were placed inside the tubes close to the sealed end. Dried spores of Bacillus stearothermophilus adhering to linen threads served as test organisms. The test results varied according to the material of the test pieces and the thickness of their walls (see Table 1). In flexible tubes made of silicon rubber, all bioindicators became sterile, in tubes of stainless steel, all bioindicators exhibited test organisms that had survived. The findings for materials such as polyvinyl chloride, polyethylene, polyamide and polytetrafluorethylene ranged between these two extremes; the frequencies of bioindicators containing viable germs were 10, 55, 68 and 85%, respectively. Rigid and flexible tubes which had been sealed at both ends served to demonstrate that silicon rubber and polyvinyl chloride were highly permeable for formaldehyde and water vapour. Also the other plastic materials tested were permeable for formaldehyde and water vapour but longer exposure periods were needed to create conditions in the interior of the tubes that would result in a killing of the test organisms (see Fig 2). In this respect, polyamide exhibited a peculiar behaviour. The number of viable spores remained at the initial level for a long period before a decline took place. From the results of testing, it is concluded that test pieces must conform to the objects to be sterilized not only in their dimensions (length, inner diameter) but also in the characteristics of their material. The walls of the test pieces should not have a higher permeability for formaldehyde and water vapour than the material to be sterilized. The highest demands on the efficiency of formaldehyde gas sterilization procedures are those created by mental tubes and thick-walled flexible polytetrafluorethylene. Instruments and devices to be sterilized by a formaldehyde gas procedure should be preferentially made of materials which are sufficiently permeable for formaldehyde and water vapour as e.g. silicon rubber. Such gas-permeable components may considerably facilitate the sterilization of cavities which have a small lumen and are difficult to reach.

Chromium↗

Computer predictions of abnormal test results. Effects on outpatient testing.

We developed statistical equations to predict abnormalities on eight commonly ordered diagnostic tests and we gave the predictions to 112 physicians practicing in an academic internal medicine practice. Half of each physician's patients were randomized to intervention status. All diagnostic tests were ordered by microcomputer, and when a physician ordered one of the eight study tests for an intervention patient, the computer displayed the probability (0% to 100%) that the test would be positive for the main abnormality being tested for. The physician could then cancel the test if desired. During a six-month controlled trial, when there were more than 15,000 scheduled patient visits, patient charges for the eight study tests were 8.8% less for the intervention patients. The largest reductions (greater than 10%) were for serum electrolyte level tests and complete blood cell counts, the two most commonly ordered tests. Physicians ordered fewer low-probability tests for intervention patients than for controls, suggesting that with timely predictive information, physicians can target tests to higher-risk patients.

Clinical Laboratory Techniques↗

Auditory brain stem response test battery for multiple sclerosis patients: evaluation of test findings and assessment of diagnostic criteria.

A battery of auditory brain stem response (ABR) tests has been used to evaluate 39 multiple sclerosis (MS) subjects (9 with probable, 8 with possible, 6 with suspected and 16 with definite MS, according to conventional classification of the disease). Test battery included evaluation of ABR waveform, latencies and interpeak intervals, test-retest variability, rate-induced ABR changes, binaural increase of wave-V amplitude and effect of ipsilateral masking with broad-band noise. Test results allowed a measure of the sensitivity, specificity and efficiency of each test in the battery. The high efficiency values thus obtained validated each test in the battery when normals were compared with definite MS patients. No single test, however, proved to be sufficient--by itself--to reliably distinguish subjects with earlier stages of the disease, suggesting that a combined evaluation of tests is necessary to fit better the clinical classification. When compared with 'conventional' ABR analysis, 'sensitized' ABR tests--i.e. the measures of test-retest variability, binaural increase of wave-V amplitude and the effect of ipsilateral broad-band noise masking--showed higher percentages of positive results in subjects with no clinical signs of brainstem and midbrain involvement. Sensitized tests therefore appeared more suitable to reveal a brainstem subclinical involvement.

Adolescent↗

[Demonstration of enterotoxin in Staphylococcus aureus cultures by the ELISA test and the microslide test].

340 S. aureus strains, isolated either from routine food test samples, or from food leftovers, from healthy or sick persons in cases of suspected food poisoning in various places of the Federal Republic of Germany, were tested for enterotoxin production. The enterotoxin types A, B and C (SEA, SEB and SEC) were determined both by the ELISA and the microslide test (MS-test), the enterotoxin types D and E by the MS-test only. Comparison of the two test methods clearly shows that the ELISA technique is superior to the MS method: The sensitivity of the ELISA was at 2.5 ng, whereas that of the MS-test was limited to approximately 1 microgram. The ELISA revealed 6.2% more of the strains as enterotoxin producers, and reproducibility of the test results was also better with the ELISA than with the MS-test. Furthermore, the ELISA is far more efficient, consuming less test reagents, and with a capacity for testing more strains in a shorter time procedure. The incidence rate of the various enterotoxin types, referred to one representative strain each per outbreak of food poisoning or group of persons investigated, is as follows: 45.3% SEA, 17.2% SEB, 23.4% SEC. The incidence rate of SED, SEE or SE-type combinations was less than 5%. In sick persons, SEA- and SEC-producing strains occurred within the same range, i.e. 34.8% and 30.4% respectively. SEA-producing S. aureus strains had the highest frequency in food samples (61.5%) and in healthy individuals (53.6%).

Enterotoxins↗

Comparative value of Dapsone "spot test" and Dapsone "tile test" in leprosy control programme.

The sensitivity of Dapsone "spot test" with modified Ehrlich's reagent (Balakrishnan, 1968) and Dapsone "tile test" using Barton-Marshall reagents (Irudayraj, 1981)--both being qualitative tests for screening of dapsone in urine are compared with Dapsone/creatinine ratio--a quantitative test (Ellard, 1974). 316 urine samples were processed by paramedical worker in the fields for Dapsone "Tile test" and Dapsone "Spot test". The same samples were brought to the laboratory and subjected to these two tests besides Dapsone/creatinine estimation. These three tests correlated well at the level of 91%. The results obtained by paramedical workers and experienced worker at the laboratory are also showed 97% concordance. An earlier investigations revealed that monitoring through frequent and surprise check-up of urines for drug content (4-5 samples/year/patient) and subsequent motivation and persuation of leprosy patient, the irregularity rate of drug consumption by patient could be brought down from 36% to 17% in one year. The kit for performing DDS "spot test" and DDS "tile test" being light and easy to carry in the field and the tests being simple to perform with reliable results. This procedure is recommended to be applied in the field on a mass scale. The routine frequent and surprise checking of urine for drug content will give early idea about irregularity status of drug consumption by patients as compared to the judgement relying on clinical assessment and reduction of bacteriological index of infectious patients.

Colorimetry↗

Nitroblue tetrazolium slide test. Use of the phorbol-myristate-acetate-stimulated NBT-reduction slide test for routine and prenatal detection of chronic granulomatous disease and diagnosis of heterozygous carriers.

Chronic granulomatous disease (CGD) in utero has recently been detected by a new qualitative nitro blue tetrazolium (NBT) reduction slide test using phorbol-myristate-acetate (PMA) as a stimulus. The technique is simple and inexpensive and requires only a few microlitres of blood. Reported here is an evaluation of this method as applied to routine clinical diagnosis. The blood granulocytes from 300 normal individuals and 49 CGD patients and their relatives were tested and the results compared to the conventional in vitro function tests. In normal individuals the number of abnormal cells was very low never exceeding 2% of granulocytes. CGD patients (14 out of 15) diagnosed by conventional functional tests showed no positive cells in the NBT-PMA test. One patient diagnosed by functional tests had 4% positive cells. Thirty-four relatives of these patients were tested and eleven were found to have fewer positive cells than normal in the NBT-PMA slide test ranging from 16-88% of all granulocytes. These are presumably carriers, a finding supported by granulocyte function tests. All these individuals were female, mothers, sisters or maternal aunts of male CGD patients, thus presumably X-linked heterozygote carriers of CGD. An example of successful prenatal diagnosis using the PMA-NBT test is described. The results show that the PMA-NBT test provides a simple and reproducible method for routine diagnosis of CGD and CGD X-linked heterozygote carriers.

Female↗

The results of the "essential laboratory tests" applied to new outpatients--re-evaluation of diagnostic efficiencies of the test items.

We have analyzed diagnostic efficiencies of the individual "Essential laboratory test" items when these tests were applied to 520 new outpatients in the division of comprehensive medicine in a teaching hospital. The integration of these test results with history-taking and physical examination resulted in 544 primary clinical diagnoses which corresponded to the patient's illness complained and in 361 additional diagnoses unrelated to their chief complaints but found by chance by the addition of the test results. Clinical usefulness of these test items were variable depending on the disease category, demonstrating a superior diagnostic efficiency in infectious or inflammatory diseases, liver and biliary tract diseases, hematological disorders or metabolic diseases such as hyperlipidemia and diabetes mellitus, but a lesser degree of usefulness in gastro-intestinal or neurogenic diseases. Urine urobilinogen could not establish its clinical usefulness because of extremely low diagnostic sensitivity even in liver diseases. The leukocyte differential count provided confirmatory information for infectious or inflammatory diseases and was helpful for the estimation of the etiologic nature of infectious diseases. This study failed to terminate a controversy for the adoption of sialic acid instead of erythrocyte sedimentation rate (ESR) in the "Essential laboratory test" items, since the former test showed lower sensitivity, even though higher specificity, in infectious or inflammatory status than ESR. Low albumin globulin ratio (A/G) revealed equivalent diagnostic sensitivity and specificity to the elevated levels in alpha 1 and/or alpha 2 globulin fractions in infectious or inflammatory status, being helpful for the evaluation of patient's general condition at a glance. Incidental analysis for diagnostic values of cholinesterase and random blood glucose for the detection of fatty liver and diabetes mellitus, respectively, suggested that these two tests may be included in the "Essential laboratory tests". Simultaneous measurement of serum creatinine and blood urea nitrogen levels was recommended for the ambulatory screening of renal insufficiency, rather than the measurement either alone. The results in this study provide scientific bases on the usefulness of the individual test items and should be taken into account in the next version of the "Essential laboratory tests".

Adolescent↗

[Quantification and evaluation of 5 neurological equilibrium tests in test subjects and patients].

OBJECTIVE: Quantification and evaluation of five neurological balance tests as part of the routine neurological examination in order to obtain objective test results for healthy individuals and several neurological patient groups. SETTING: Department of neurology, University Hospital Groningen, the Netherlands. DESIGN: Prospective, controlled study. METHODS: 220 subjects (113 healthy individuals and 107 neurological patients) participated in a balance test investigation comprising gang board, Romberg's test, tandem gait, one-leg-stance, hopping. Tests were performed on a hopscotch (3 meters long, divided in 6 rectangles of 20 by 50 cm) and using a stopwatch to register times and faults. RESULTS: All five quantified tests were feasible for healthy individuals. Up to the age of 70 results gradually declined, above 70 a strong decline was observed. Patients with gait and balance disorders performed less well in all tests except the Romberg's test. CONCLUSIONS: Taking into account a strict standardisation of these five existing tests standard values were obtained for a fast and simple quantification of balance in the routine neurological examination, which can also be used to monitor progress. Especially the results obtained in tandem gait, one-leg-stance and hopping differ significantly between healthy individuals and patients. The gang board appears to be useful for quantifying serious balance disorders. Romberg's test is a specific test for the perceptual sensibility and does not belong in the routine neurological examination of balance.

Adult↗

Update: HIV counseling and testing using rapid tests--United States, 1995.

Approximately 25 million persons each year in the United States are tested for antibody to human immunodeficiency virus (HIV). Publicly funded counseling and testing (CT) programs conduct approximately 2.5 million of these tests each year. CT can have important prevention benefits; however, in 1995, 25% of persons testing HIV-positive and 33% of persons testing HIV-negative at publicly funded clinics did not return for their test results. Rapid tests to detect HIV antibody can be performed in an average of 10 minutes, enabling health-care providers to supply definitive negative and preliminary positive results to patients at the time of testing, potentially increasing the overall effectiveness of CT. In comparison, results from enzyme immunoassays (EIAs) currently used for HIV screening often are not available for 1-2 weeks. To quantify the potential advantages and disadvantages of using rapid tests for CT, CDC estimated the potential impact on the number of persons who would learn their HIV-test results. This report summarizes the results of the analysis and provides the basis for changing the Public Health Service (PHS) recommendations for providing HIV-test results.

AIDS Serodiagnosis↗