TThe Syva MicroTrak Chlamydia enzyme immunoassay (EIA; Syva Company, San Jose, Calif.) with cytospin and direct fluorescent-antibody assay (DFA) confirmation was evaluated on 43,630 urogenital specimens over a 1-year period in the Provincial Laboratory in Regina, Saskatchewan, Canada. This was a two-phase study intended to define a testing algorithm for Chlamydia trachomatis that would be both highly accurate and cost-effective in our high-volume (> 3,000 tests per month) laboratory. The prevalence of C. trachomatis infection in our population is moderate (8 to 9%). In phase 1, we tested 6,022 male and female urogenital specimens by EIA. All specimens with optical densities above the cutoff value and those within 30% below the cutoff value were retested by DFA. This was 648 specimens (10.8% of the total). A total of 100% (211 of 211) of the specimens with optical densities equal to or greater than 1.00 absorbance unit (AU) above the cutoff value, 98.2% (175 of 178) of the specimens with optical densities of between 0.500 and 0.999 AU above the cutoff value, and 83% (167 of 201) of the specimens with optical densities within 0.499 AU above the cutoff value were confirmed to be positive. A total of 12% (7 of 58) of the specimens with optical densities within 30% below the cutoff value were positive by DFA. In phase 2, we tested 37,608 specimens (32,495 from females; 5,113 from males) by EIA. Only those specimens with optical densities of between 0.499 AU above and 30% below the cutoff value required confirmation on the basis of data from phase 1 of the study. This was 4.5% of all specimens tested. This decrease in the proportion of specimens requiring confirmation provides a significant cost savings to the laboratory. The testing algorithm gives us a 1-day turnaround time to the final confirmed test results. The MicroTrak EIA performed very well in both phases of the study, with a sensitivity, specificity, positive predictive value, and negative predictive value of 96.1, 99.1, 90.3, and 99.7%, respectively, in phase 2. We suggest that for laboratories that use EIA for Chlamydia testing, a study such as this one will identify an appropriate optical density range for confirmatory testing for samples from that particular population.
OBJECTIVE--To assess the cost-effectiveness of identifying asymptomatic carriers of Chlamydia trachomatis among adolescent males. DESIGN--Cost-effectiveness analysis based on cohort analytic studies previously reported and average salaries and costs of medical care in Sweden. SETTING--Adolescent males attending a primary care center for routine health checks. PARTICIPANTS--Estimates of costs and benefits are based on a cohort of 1000 adolescent males and their female contacts. INTERVENTION--Screening with enzyme immunoassay (EIA), either on leukocyte esterase (LE)--positive urine samples (LE-EIA screening) or on all urine samples (EIA screening), was compared with no screening (no treatment or contact tracing). The effects of confirming positive EIA results with a blocking assay and alternative antibiotic regimens on the outcome of the screening strategies were also evaluated. RESULTS--Compared with no screening, the LE-EIA and EIA screening strategies reduced the overall costs when the prevalence of chlamydial infection in males exceeded 2% and 10%, respectively. Enzyme immunoassay screening achieved an overall cure rate that was 12.2% to 12.6% (95% confidence interval) better, but reduced the incremental savings by at least $2144 per cured male, in comparison with LE-EIA screening. Confirmation of positive EIA results reduced the overall cost of the LE-EIA screening strategy when the prevalence of C trachomatis among males was less than 8%. Compared with a 7-day course of doxycycline, a single oral dose of azithromycin administered under supervision in the clinic improved the cure rates of both EIA and LE-EIA screening strategies by 15.1% to 16.3% and 11.2% to 12.0%, respectively, while reducing the corresponding overall costs by 5% and 9%, respectively, regardless of the prevalence of chlamydial infection in males. CONCLUSION--The use of LE-EIA screening combined with treatment of positive cases with azithromycin was the most cost-effective intervention strategy focusing on asymptomatic male carriers of C trachomatis. Positive EIA results should be confirmed when screening low-risk populations.
Comment In: JAMA. 1993 Nov 3;270(17):2097-88411579
We noted a marked increase in Chlamydia trachomatis (CT) infections in the Capital Health Region of NS coincident with substitution of a PCR for an enzyme immunoassay (EIA). We reviewed our experience to determine the cost of switching and the impact on the number of new infections diagnosed.
Information on the number of EIA and PCR tests performed on women was retrieved from an abstracted laboratory information database. We examined records of testing performed between April 1998 and December 2001. Prior to June 2001, all genital swabs were tested using the MicroTrak, II Chlamydia EIA and confirmed by direct fluorescence examination. After July 2001, genital swabs were tested using the COBAS AMPLICOR C. trachomatis test.
During the study period, 62,288 EIA tests were performed on specimens submitted; 2,061 (3.33%) were positive. In the six months when testing was performed by the PCR method, 9,559 PCR tests were performed, 463 (4.84%) were positive; 46% increase. In the three years before PCR testing was implemented, an average of 1,626 specimens were submitted monthly. An average of 54 tests were positive (3.3%). The cost for each positive detected by PCR was 208 dollars Cdn and 226 dollars by EIA.
The switch to PCR for the diagnosis of CT produced a marked increase in the number of chlamydia infections diagnosed. The recent increase in the number of reported CT cases in Canada may be due in large part to more sensitive tests. Surprisingly, the cost of each positive test by PCR was 18 dollars Cdn less than that of the EIA.
In many clinical situations, stool examinations for ova and parasites (O&P) are routine in the work-up of patients with acute or chronic diarrhea. Frequently, these tests are found to be negative for pathogens. The purpose of this study was to examine the diagnostic yield of routine stool testing for O&P in a Canadian tertiary care centre and to estimate the potential clinical benefit of a positive result.
All stool samples sent to the central microbiology laboratory at London Health Sciences Centre were reviewed over a 5-year period ending January 2010. Initial screening was done by direct antigen testing using an enzyme immunoassay (EIA) technique followed by direct microscopy for negative results where there was a high index of suspicion and for positive results to rule out any concurrent parasites not included in the EIA kit. Pathogens identified were categorized and their potential susceptibility to metronidazole was estimated. No clinical data were available, as this was purely a utilization study.
A total of 5812 stool tests were ordered. Of these, 5681 (97.7%) were completed. The most common reasons for an incomplete test were sample leakage (n = 38) and use of the incorrect collection kit (n = 32). Direct microscopy identified white blood cells in 17% of patients with positive testing. The most common pathogen was Giardia lamblia , which was detected in 45/83 (54%) of positive specimens. Entamoeba histolytica/Entamoeba dispar was identified in 16/83 (19%) and Cryptosporidium spp. in 10/83 (12%) of positive specimens. Microorganisms not thought to be pathogenic were identified in 7/83 (8%). Direct laboratory costs independent of labor were estimated at $1836 per clinically significant organism identified. Of the 77 specimens positive for pathogenic organisms, 62 (81%) were likely to be sensitive to treatment with metronidazole.
In a tertiary care centre, the diagnostic yield of routine testing of stool for O&P during the evaluation of patients with acute or chronic diarrhea is low. Most clinically significant positive results should be responsive to metronidazole, but empirical treatment is not encouraged. Strategies to identify patients with a higher likelihood of harboring pathogenic parasites and consideration of empiric metronidazole therapy for patients at highest risk merit further research.
Although bacterial culture is considered to provide the most definitive diagnosis of gonorrhea, it has limitations when specimens must be transported long distances. A study was carried out to evaluate the validity and cost-effectiveness of an alternative method of diagnosing gonorrhea, the Gonozyme test, a commercially available enzyme immunoassay. Urogenital specimens from 100 men and 100 women with symptoms suggestive of or a history of exposure to gonorrhea were tested for the presence of Neisseria gonorrhoeae by means of bacterial culture and for gonococcal antigen with the Gonozyme test. The specimens from the men were also examined by means of microscopy of Gram-stained smears. The sensitivity and specificity of the Gonozyme test with reference to culture results were 95.6% and 97.4% respectively in the men and 84.2% and 98.7% in the women. The predictive value of a positive result was 91.6% in the men and 94.1% in the women, and the predictive value of a negative result 98.6% in the men and 96.3% in the women. The cost-effectiveness of the Gonozyme test was higher than that of bacterial culture in this population, which had a high prevalence rate of gonorrhea (23% in the men and 19% in the women). The Gonozyme test would be an adequate alternative to culture for the diagnosis of gonorrhea and contact tracing in areas far from diagnostic laboratories.
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