A 1-year evaluation of Syva MicroTrak Chlamydia enzyme immunoassay with selective confirmation by direct fluorescent-antibody assay in a high-volume laboratory.
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.
A 2-dose regimen of a recombinant hepatitis B vaccine with the immune stimulant AS04 compared with the standard 3-dose regimen of Engerix-B in healthy young adults.
An open-label randomized study was undertaken to compare a 2-dose regimen (Months 0 and 6) of hepatitis B surface antigen (HBsAg) vaccine formulated with a novel adjuvant (HBsAg/AS04) with a standard 3-dose regimen (Months 0, 1 and 6) of licensed recombinant HBsAg vaccine in terms of immunogenicity and reactogenicity when administered to healthy subjects aged between 15 and 40 y. At 1 and 6 months after the full vaccination course there was a 100% seroprotection rate (anti-HBs > or = 10 mIU/ml) with the HBsAg/AS04 vaccine, compared with a 99% response rate with the licensed vaccine. The corresponding geometric mean titres were significantly higher for the novel vaccine compared to the standard vaccine: 15,468 and 2,745 mIU/ml at Months 7 and 12 vs. 6,274 and 1,883 mIU/ml, respectively. There was a higher prevalence of local symptoms with the adjuvant vaccine (90% of doses) than with the standard vaccine (48% of doses). However, these symptoms (pain, swelling and redness) were predominantly of mild-to-moderate intensity and resolved rapidly without treatment. A 2-dose regimen of the new HBsAg/AS04 adjuvant vaccine therefore compared favourably to the standard regimen in healthy young adults. It is anticipated that the simplified vaccination schedule may improve compliance and reduce costs.
An activity comparison of tritiated water was organized in 2013 between 3 laboratories: FTMC (Lithuania), LNE-LNHB (France) and VNIIM (Russia). The solution was prepared by LNHB and ampoules were sent to the others laboratories. This solution was standardized in terms of activity per unit mass by participant laboratories using the Triple to Double Coincidence Ratio (TDCR) method in liquid scintillation counting (LSC). The tritiated water solution is traceable to the solution prepared by LNHB for the CCRI(II)-K2.H-3 2009 (3)H international comparison.
BACKGROUND: The mean wheal diameter >/= 3 mm is the usual criterion for positive skin prick test (SPT) reaction to dust mites. The study assessed the accuracy of this SPT criterion with respect to specific IgE values of above 0.35 kUA/l (+ sIgE). METHODS: Specific IgE (ImmunoCAP, Pharmacia AB Diagnostics, Uppsala, Sweden) and standard SPT to Dermatophagoides pteronyssinus (DP) and farinae (DF), Lepidoglyphus destructor (LD) and Tyrophagus putrescentiae (TP) (ALK, Hørsholm, Denmark) were performed in a random sample of 457 subjects, of whom 273 men (mean age 35.3 +/- 11.0 years) and 184 women (mean age 37.9 +/- 9.5 years). Statistical analysis was performed using the chi-square test, regression analysis and discriminant analysis. RESULTS: When the mean wheal diameter of >/= 3 mm was considered positive (+ SPT), the correlation between + SPT and + sIgE was 0.47 for DP (P
OBJECTIVES: To validate the use of an activity diary and predicted BMR for assessment of daily total energy expenditure (TEE) and physical activity level (PAL = TEE/BMR) in adolescents. DESIGN: TEE and PAL estimated from activity diary records kept for seven days and BMR predicted from age, gender and body weight were compared with the results of doubly labelled water (DLW) measurements and indirect calorimetry performed during the same time period. SETTING: The Unit of paediatric Physiology of the Department of Clinical Physiology, University Hospital, Uppsala, Sweden. SUBJECTS: Fifty randomly selected 15 y old adolescents (25 boys and 25 girls). RESULTS: The mean difference between TEE estimated in all adolescents by the activity diary and by DLW methods was 1.2%. The limits of agreement (mean difference 2 s.d.) were -3.47 and 3.77 MD/d, equivalent to a coefficient of variation of 15%. The mean difference between PAL assessed by activity diary records and by DLW measurements was 0.001, and the limits of agreement between the two methods were 0.54. CONCLUSIONS: The results imply that the activity diary method provides a close estimate of TEE and PAL in population groups.
Department of Clinical Microbiology, Karolinska University Hospital and Department of Clinical Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
The aim was to evaluate 16S rDNA sequencing in heart valves in patients with infective endocarditis undergoing surgery.
Fifty-seven patients with infective endocarditis were examined in this prospective study by analysing heart valves with 16S rDNA sequencing and culturing methods and comparing the results to blood cultures. As controls, heart valves from 61 patients without any signs of endocarditis were examined.
All together 77% of the endocarditis patients were positive for 16S rDNA, 84% had positive blood cultures and 23% had positive cultures from heart valves, whereas only 16% of the cultures from heart valves were concordant with results from blood cultures or 16S rDNA. Concordant results between 16S rDNA sequencing and blood cultures were found in 75% patients. All controls were negative for 16S rDNA. In 4 out of 9 patients with negative blood cultures, the aetiology was established by 16S rDNA alone, i.e. viridans group streptococci.
In this Swedish study, 16S rDNA sequencing of valve material was shown to be a valuable addition in blood culture-negative cases. The value of heart valve culture was low. Molecular diagnosis using 16S rDNA sequencing should be recommended in patients undergoing valve replacement for infective endocarditis.
18F-fluorodeoxyglucose positron emission tomography-computed tomography for suspected recurrent papillary thyroid cancer: early experience at Sunnybrook Health Sciences Centre.
To report the initial experience with combined 18F-fluorodeoxyglucose positron emission tomography (FDG PET)/computed tomography (CT) imaging for suspected recurrent papillary differentiated thyroid cancer (DTC) at Sunnybrook Health Sciences Centre (SHSC), Toronto.
Single institution retrospective study.
Consecutive patients from SHSC who underwent FDG PET/CT imaging for suspected recurrent DTC over a period of 2.5 years were identified and their charts reviewed.
Qualitative appraisal of FDG PET/CT imaging in suspected recurrent DTC.
Sixteen patients (14F, 2M) were identified accounting for 17 FDG PET/CT scans. Three scans (18%) in 3 different patients were reported as suspicious for recurrent disease in the neck (1-3 lesions) and were considered "positive". All were subsequently confirmed pathologically (4-13 positive lymph nodes post operatively). Prior conventional imaging was abnormal in two patients. Two patients had an elevated non-stimulated thyroglobulin (TG)
Results of standard patch tests performed with the same methodology in one centre are rarely available over a large time span. This gives the unique opportunity to study not only prevalence but also persistency of contact allergy and characterize subpopulations. The objectives were to investigate sensitivity rates and persistencies of patch test results and characterize patients with multiple contact allergies. A 20-year retrospective database-based study of 14 998 patients patch tested with the European Standard Series was performed. 34.5% were sensitized, primarily women. Sensitivity to nickel was most frequent and least frequent to mercaptobenzothiazole, N-isopropyl-N-phenyl-p-phenylenediamine and benzocaine. Yearly proportion of negative, mono/double-allergic, and multiple-allergic cases remained stable. Persistency of positive reactions was high for para-phenylenediamine, Cl(Me)isothiazolinone, and primin and poor for paraben mix. 5.1% were multiple allergic, primarily women, and 90% got diagnosed by the first test. Frequency of multiple allergies increased with age. More multiple- than mono/double-allergic patients were tested multiple times. Persistency and sensitivity rates in a Danish eczema population are provided and are useful for decisions regarding the standard series. Patients with multiple contact allergies are typically elderly women who might have long-lasting and hard-to-treat eczema. Cumulative environmental exposure seems necessary to develop multiple allergies.
The objective of the study was to determine completeness of 24-hour urine collection in pregnancy.
This was a retrospective laboratory/chart review of 24-hour urine collections at British Columbia Women's Hospital. Completeness was assessed by 24-hour urinary creatinine excretion (UcreatV): expected according to maternal weight for single collections and between-measurement difference for serial collections.
For 198 randomly selected pregnant women with a hypertensive disorder (63% preeclampsia), 24-hour urine collections were frequently inaccurate (13-54%) on the basis of UcreatV of 97-220 micromol/kg per day (11.0-25.0 mg/kg per day) or 133-177 micromol/kg per day (15.1-20.1 mg/kg per day) of prepregnancy weight (respectively). Lean body weight resulted in more inaccurate collections (24-68%). The current weight was frequently unavailable (28%) and thus not used. For 161 women (81% proteinuric) with serial 24-hour urine levels, a median [interquartile range] of 11 [5-31] days apart, between-measurement difference in UcreatV was 14.4% [6.0-24.9]; 40 women (24.8%) had values 25% or greater, exceeding analytic and biologic variation.
Twenty-four hour urine collection is frequently inaccurate and not a precise measure of proteinuria or creatinine clearance.
Finnish Cancer Registry, Institute for Statistical and Epidemiological Cancer Research, Liisankatu 21 B, FI-001 70 Helsinki, Finland. nea.malila@cancer.fi
The aim of the study was to assess the feasibility of and possible selection to attend in colorectal cancer screening.
During the years 1979-1980, 1 785 men and women (born in 1917-1929) were invited to a pilot screening project for colorectal cancer. The screening method used was a guaiac-based faecal occult blood test repeated once if the initial test was positive.
Compliance was 69% and the test was positive in 19% of those attending. In a record linkage with the Finnish Cancer Registry, 47 colorectal cancer cases and 24 deaths from colorectal cancer were observed by the end of 2004. In all, the particular test method was not regarded specific enough for population screening. There was, however, no difference in cancer incidence between those who complied and those who did not when compared to the general population of same age and gender.
Compliance was found high enough to make screening feasible and there was no self selection of persons with low cancer risk to attend screening.
