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At least 19 recordsLinked to original sources

[Detection of Chlamydia trachomatis from urine sediment by PCR diagnostic reagent kit].

Chlamydia trachomatis detection by both swab CHLAMYDIAZYME and urine sediment AMPLICOR were performed on 61 males and 54 females who were suspected to have C. trachomatis genital infection (CTGI). Positive agreement between swab CHLAMYDIAZYME and urine sediment AMPLICOR was good, 96.9% in males and 96.6% in females. Negative agreement was 100% in males and 84.0% in females. "Swab CHLAMYDIAZYME positive-Urine sediment AMPLICOR negative specimen" were not obtained. "Swab CHLAMYDIAZYME negative-urine sediment AMPLICOR positive" resulted in four females who were finally diagnosed to have CTGI by repeated specimens on CHLAMYDIAZYME. Positive result by AMPLICOR was obtained on un-spun urine specimen that was in agreement with the laboratory result that the sensitivity of AMPLICOR reaches one thousand fold of CHLAMYDIAZYME. Detection on every separately collected urine specimen of one urination showed AMPLICOR positive all through the last cup specimen in both male and female. Those results seem to certify the reliability of C. trachomatis detection by urine sediment AMPLICOR. False negative by interference substance in urine and false positive by contamination were not experienced. On asymptomatic young male and female, positive rates of urine sediment AMPLICOR were 7.5% in male and 12.1% in female which are far more than the positive rate obtained by CHLAMYDIAZYME. Non invasive C. trachomatis detection method applicable to asymptomatic female is needed for control of CTGI. C. trachomatis detection could be facilitated by non invasive urine sediment AMPLICOR.

Adult↗

Urinary-based ovulation and pregnancy: point-of-care testing.

OBJECTIVE: To review the literature concerning ovulation prediction devices and pregnancy detection tests for home use. DATA SOURCES: Articles were identified through searches of the MEDLINE (1966-May 2003), EMBASE (1980-May 2003), and International Pharmaceutical Abstracts (1970-May 2003) databases using the key words ovulation, ovulation detection, pregnancy test, diagnostic reagent kit, and diagnostic test. Additional references were located through review of the bibliographies of the articles found in the literature search. Searches were not limited by time restriction, language, or use of human or animal subjects. STUDY SELECTION AND DATA EXTRACTION: Review articles, textbook chapters, and experimental and observational studies on home use ovulation and pregnancy tests were selected. DATA SYNTHESIS: Luteinizing hormone (LH)-based ovulation tests have demonstrated accurate and superior ovulation detection when compared to basal body temperature charting, calendar calculation, salivary ferning, or observation of vaginal or cervical discharge changes. Systems using LH and estrone-3-glucuronide (E3G) have also demonstrated accurate detection of the fertile period. Literature evaluating home use of pregnancy tests has demonstrated accurate use by lay persons. CONCLUSIONS: Urinary-based ovulation prediction and pregnancy detection tests available for use by nonprofessionals enable women and couples to take an active role in the family planning process. Numerous products are available at reasonable costs to the consumer.

Female↗

Presence of antibodies to human immunodeficiency virus-1 in reference reagents of human origin in diagnostic kits.

We tested 54 reagents of human origin that were included in a number of diagnostic kits to be used as positive or negative control material, and for quality assurance, for the presence of antibodies to human immunodeficiency virus-1 (HIV-1). Of these, 12 (22%) reagents were found to give positive results for antibodies to HIV-1 by enzyme-linked immunosorbent assay and/or supplementary tests. These results suggest that some diagnostic reagents of human origin may be contaminated with HIV-1 and potentially may be infectious.

Antibodies, Viral↗

[Antigen sandwiched ELISA for detection of total HIV antibodies].

OBJECTIVE: To establish a sensitive antigen sandwiched ELISA(AS) for detection of the total antibodies to HIV-1/2. METHODS: Based on the gene sequence of HIV-1/2 type and its coded amino acid structure, 5 polypeptides were synthesized as coated antigens using solid-phase method. These polypeptides were labelled with horseradish peroxidase. And the total antibodies of HIV-1/2 were detected with the same method. RESULTS: These reagents were detected by three batches of HIV panel from The National Institute for the Control of Pharmaceutical and Biological Products (NICPBP). The results indicated that the corresponding rate was 100%. The variant coefficient rate was less than 10%. A comparison of antigen sandwiched ELISA with indirect ELISA in detection of a panel(20 positive sera and 20 negative sera) from the NICPBP showed that the general coincident rate of indirect ELISA was 92.5% and the sandwiched system was 100%. The HIV-AS diagnostic reagent kits have passed the quality examination of NICPBP. A comparison of antigen sandwiched ELISA with Yapei reagents in detection of 90 normal sera and 88 positive sera for HIV-1/2 showed that the coincident rate was 100%. The reagents were stable at 37 degrees C for 4 days. This indicated that our reagents were highly specific, sensitive and stable. CONCLUSION: Our antigen sandwiched ELISA reagent for total antibodies of HIV has a merit of sensitivity specificity and stability. It can be clinically used for detection of HIV-1/2 infection and in blood bank for the screening of blood donors.

Adult↗

New rapid kit for determining calcium in serum and urine evaluated.

We describe the performance of a colorimetric reagent kit (Diagnostic Systems Laboratories, Inc., Webster, TX 77598) for measuring calcium directly in urine, serum, and ultrafiltered serum, and compare the results with those obtained with atomic absorption spectrophotometry. The CV for within-run precision was 2.8 and 2.1% for urine and whole serum, respectively (n = 10 each). Between-run precision for urine, whole serum, and ultrafiltered serum was 1.9, 1.6, and 2.2%, respectively (n = 8 to 10). Analytical recovery of added calcium from three different urine and serum specimens, to which three different concentrations of calcium had been added, was 101.9 (SD 0.3%) for urine and 100.9 (SD 0.2%) for serum. Assay of 30 urine specimens, 15 ultrafiltered serums, and 20 whole serums by both the kit and atomic absorption spectrophotometry demonstrated correlation coefficients of 0.993, 0.828, and 0.751, respectively. Mg2+, hemolysis, or lipemia does not interfere. Compared with atomic absorption spectrophotometry, the calcium kit procedure is rapid and simple.

Bromthymol Blue↗

Evaluation of dipstick serologic tests for diagnosis of brucellosis and typhoid Fever in egypt.

Two dipstick assays for the detection of Brucella- and typhoid-specific immunoglobulin M, recently developed by the Royal Tropical Institute of The Netherlands, were evaluated by use of 85 plasma samples from Egyptian patients. Both dipsticks were simple and accurate rapid diagnostic assays, and they can be useful adjuncts for the diagnosis of typhoid fever and brucellosis.

Antibodies, Bacterial↗

MalaQuick versus ParaSight F as a diagnostic aid in travellers' malaria.

In this study we assessed whether travellers can perform malaria rapid tests, following the provided information leaflet, and correctly interpret performed and pre-prepared test strips. Two Plasmodium falciparum testing systems, namely MalaQuick (ICT) and ParaSight F were used. Test performance and test interpretation of pre-prepared tests were compared. There was no significant difference in test performance between the 2 tests. Interpretation of prepared test strips in both test systems was very reliable in blood parasite densities between 0.1% and 2%, but major problems were encountered at low parasitaemia (< 0.1% blood parasites) and also in ParaSight F test strips showing high parasitaemia (> 2% blood parasites). Low parasitaemia ParaSight F test strips were correctly interpreted by 52.1% compared with 10.8% correct interpretations with MalaQuick (P < 0.0001). Correct interpretation of highly positive (> 2% blood parasites) pre-prepared test strips was higher with MalaQuick (96.8%) than with ParaSight F (33.8%), P < 0.0001. Both tests were associated with high levels of false-negative interpretations which render them unsuitable as self-diagnostic kits. Efforts must be made to assist lay individuals in test performance by technical test improvement, by equiping the test strips with an additional reading aid for interpretation, and by providing instruction by a skilled person.

Adult↗

Field validation of sensitivity and specificity of rapid test for detection of Brugia malayi infection.

We conducted a field study of a rapid test (Brugia Rapid) for detection of Brugia malayi infection to validate its sensitivity and specificity under operational conditions. Seven districts in the state of Sarawak, Malaysia, which are endemic for brugian filariasis, were used to determine the test sensitivity. Determination of specificity was performed in another state in Malaysia (Bachok, Kelantan) which is non-endemic for filariasis but endemic for soil-transmitted helminths. In Sarawak both the rapid test and thick blood smear preparation were performed in the field. The rapid test was interpreted on site, whereas blood smears were taken to the district health centres for staining and microscopic examination. Sensitivity of Brugia Rapid dipstick as compared with microscopy of thick blood smears was 87% (20/23; 95% CI: 66.4-97.2) whereas the specificity was 100% (512/512). The lower sensitivity of the test in the field than in laboratory evaluations (> or =95%), was probably due to the small number of microfilaraemic individuals, in addition to difficulties in performing the test in remote villages by field personnel. The overall prevalence of brugian filariasis as determined by the dipstick is 9.4% (95% CI: 8.2-0.5) while that determined by microscopy is 0.90% (95% CI: 0.5-1.3) thus the dipstick detected about 10 times more cases than microscopy. Equal percentages of adults and children were found to be positive by the dipstick whereas microscopy showed that the number of infected children was seven times less than infected adults. The rapid dipstick test was useful as a diagnostic tool for mapping and certification phases of the lymphatic filariasis elimination programme in B. malayi-endemic areas.

Adolescent↗

[Screening for bacteriuria in the laboratory: autotrak, test strips and microscopic examination compared with culture].

A prospective investigation was undertaken to compare quantitative culture of 739 samples of urine in a microbiological laboratory with the screening methods: phase contrast microscopy examination, test strip examinations for nitrite and leukocyte esterase (Multistix-2, Ames) and "Autotrak" (automatic quantitating of the bacterial content in fluids: BBT instruments). The three screening methods were, by and large, of equal value as regards true positive diagnostic frequency (0.48-0.55) and true negative diagnostic frequency (0.92). The methods were also equally rapid but microscopy examination was by far the cheapest (0.15 Danish crowns per test as compared with 1.75 for test strips and 3.10 for "Autotrak"). In addition, microscopic examination has the further advantage, although this of lesser value where cocci are concerned, of being capable of differentiating the morphology of the bacteria and their motility. It is noted that test strips have a false negative rate of approximately 13%.

Bacteriological Techniques↗

Rapid methods in microbiology for in-office testing.

There are now a variety of rapid test methods available to assist in the diagnosis of the three most common infectious diseases seen in ambulatory medicine: pharyngitis, urinary tract infection, and venereal disease. Before choosing to implement any of these methods, several aspects should be carefully considered. The objectives met by onsite testing should be clearly identified and the appropriate test chosen to meet those objectives. For example, if the goal is to establish a diagnosis while the patient is still available in the office, a test method that requires more than 20 to 30 minutes to perform will not fulfill the objective. Similarly, if tests must be batched for maximum efficiency, timeliness of results will be compromised. The prevalence of the specific agent or disease in the patient population should be established, as prevalence will significantly influence the predictive value of a diagnostic test. The lower the prevalence of a disease, the lower the predictive value of a positive result and the higher the predictive value of a negative result. Conversely, the higher the prevalence, the higher the positive predictive value and the lower the negative predictive value. Thus, in one setting a test may serve best as a screen to rule out disease and, in another setting, as a confirmatory test to establish a diagnosis. The impact of false-positive and/or false-negative results must be clearly appreciated to avoid diagnostic errors. The technical features of a test method should be carefully appraised. How difficult is the test to perform and what skill level is necessary to ensure the validity of results? How much quality control is necessary? How much additional equipment is needed to perform the assay, and does the equipment have multiple applications or just a single application? Finally, does the cost-benefit ratio of providing on-site testing exceed that of referring the specimens to a reference laboratory?

Ambulatory Care↗