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PubMed2000

Comparison of the Serodia Treponema pallidum particle agglutination, Captia Syphilis-G, and SpiroTek Reagin II tests with standard test techniques for diagnosis of syphilis.

We compared the microhemagglutination assay for Treponema pallidum (MHA-TP), a treponemal test, with two other treponemal tests, the Serodia Treponema pallidum particle agglutination (TP-PA) assay and the Captia Syphilis-G enzyme immunoassay, using 390 clinical serum samples. We also compared two nontreponemal tests, the rapid plasma Reagin (RPR) card test and the SpiroTek Reagin II test. Agreements of the MHA-TP with the TP-PA test and the Syphilis-G test were 97.4 and 97.7%, respectively. There was 89.2% agreement between the RPR and Reagin II tests. The Reagin II test was more apt to be reactive if the treponemal test was also reactive. We conclude that either the Serodia TP-PA test or the Captia Syphilis-G test is an appropriate substitute for the MHA-TP and that the Spirotek Reagin II test could substitute for the RPR test as a screening test.

Antibodies, Bacterial↗

PubMed2004

Comparison of tuberculin skin test and new specific blood test in tuberculosis contacts.

The tuberculin skin test used to detect latent Mycobacterium tuberculosis infection has many drawbacks, and a new diagnostic test for latent tuberculosis (QuantiFERON-TB [QTF-TB]) has recently been introduced. This test measures the production of IFN-gamma in whole blood upon stimulation with purified protein derivative (PPD). The QTF-TB test addresses the operational problems with the tuberculin skin test, but, as the test is based on PPD, it still has a low specificity in populations vaccinated with the Bacille Calmette-Guérin (BCG) vaccine. We have modified the test to include the antigens ESAT-6 and CFP-10, which are not present in BCG vaccine strains or the vast majority of nontuberculous mycobacteria. This test was used to detect infection in contacts in a tuberculosis outbreak at a Danish high school. The majority of the contacts were BCG-unvaccinated, which allowed a direct comparison of the skin test and the novel blood test in individuals whose skin test was not confounded by vaccination. An excellent agreement between the two tests was found (94%, kappa value 0.866), and in contrast to the blood test based on PPD, the novel blood test was not influenced by the vaccination status of the subjects tested.

Adolescent↗

PubMed1992

Acoustic stimulation as a diagnostic test: comparison with oxytocin challenge test.

The usefulness of an acoustic stimulation test as a marker of fetal well-being was evaluated in a randomized controlled study of 121 pregnant women exhibiting a non-reactive fetal non-stress test at term. The women were randomly divided into two groups; those in the first group (n = 62) underwent an acoustic stimulation test immediately prior to an oxytocin challenge test, while those in the second (n = 59) underwent an oxytocin challenge test only. Fetal response to the acoustic stimulation was non-reactive in 22.5% of the women tested in the first group. The incidence of abnormal oxytocin challenge test among the women who were previously subjected to an acoustic stimulation was somewhat lower than among those who did not (14.5% vs. 23.7%), but the difference was not significant. In the prediction of an abnormal oxytocin challenge test, a non-reactive acoustic stimulation test had a sensitivity of 100%, a positive predictive value of 64% and a specificity of 91%. As a single test for the prediction of fetal distress in labor (n = 62), the acoustic stimulation test had a specificity and a positive predictive value similar to those of the oxytocin challenge test (n = 121), and its sensitivity was even higher (88% vs. 71%). We conclude that the acoustic stimulation test is at least as reliable as the oxytocin challenge test in the evaluation of fetal well-being in women exhibiting a non-reactive non-stress test at term.

Acoustic Stimulation↗

PubMed1994

Effects of massed versus distributed practice of test taking on achievement and test anxiety.

The effects of massed versus distributed practice on achievement and test anxiety were investigated using a quasi-experimental design employing 56 college students under two conditions. Test anxiety was assessed using Sarason's four-dimensional Reactions to Tests, while classroom achievement was measured on tests using multiple-choice applications. Experimental subjects were given four Reactions to Tests items and 10-item examinations on a weekly basis for 10 weeks, while control subjects had only a 100-item final examination. Analysis indicated (1) significantly higher final examination performance for the distributed testing condition; (2) a significant reduction in test anxiety between initial sessions and the remainder of the term in the distributed testing condition; (3) no difference in test anxiety between the distributed testing and control conditions when test anxiety was assessed at the end of the term; and (4) nonsignificant correlations between test anxiety dimensions of the Reactions to Tests and achievement in both the control and distributed testing conditions. Results support the contention that relationships between achievement and test anxiety may be more complex than previously thought.

Adaptation, Psychological↗

PubMed2001

Is the human papillomavirus test in combination with the Papanicolaou test useful for management of patients with diagnoses of atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesions?

OBJECTIVE: To determine whether human papillomavirus (HPV) testing is useful in the evaluation of patients diagnosed with atypical squamous cells of undetermined significance (ASCUS)/low-grade squamous intraepithelial lesion (LSIL) and whether the HPV test is appropriate as an alternative screening method. DESIGN: The results of Papanicolaou (Pap) tests and subsequent hybrid capture tube (HCT) II tests for high-risk-type HPV were analyzed for 457 patients. Among these tests, 208 histologic diagnoses were made and correlated with the results of Pap and HPV tests. The sensitivity and specificity of the Pap test, HPV test, and the combined method of Pap and HPV tests to detect cervical intraepithelial neoplasia (CIN) 2/3 and all CIN were also measured. RESULTS: Sixty (63.8%) of 94 women with LSIL and 31 (26.3%) of 118 women with ASCUS tested positive for high-risk HPV. The sensitivity values for Pap tests in detecting all cases of CIN and CIN 2/3 were 91.4% and 92.9%, respectively. The sensitivity values of HCT II tests using the high-risk probe for detecting all cases of CIN and CIN 2/3 were 62.6% and 88.1%, respectively. Biopsies confirmed that 10 (22.7%) of 44 LSIL patients with high-risk HPV had CIN 2/3, but only 1 (4.5%) of 22 LSIL patients without high-risk HPV had CIN 2/3. CONCLUSION: Testing for high-risk HPV with the HCT II test is useful in the detection of CIN 2/3 in LSIL groups and in the selection of patients for colposcopy in ASCUS groups, but it is not suitable for cervical cancer screening tests.

Biopsy↗

PubMed2002

Intraoperative parathyroid hormone testing: survey of testing program characteristics.

OBJECTIVE: To examine the number and testing characteristics of laboratories that offer intraoperative testing of intact parathyroid hormone (PTH). DESIGN: Laboratories (n = 355) that participated in 2001 in PTH proficiency testing with the College of American Pathologists Special Ligand Survey were surveyed about intraoperative PTH testing. RESULTS: Of the 320 laboratories that responded to the survey, 92 performed intraoperative PTH testing. Testing practices were divided nearly equally among laboratories that performed intraoperative PTH testing for all parathyroidectomies (40%), most but not all cases (31%), and less than half of cases (30%). Testing frequency usually was low, with about two thirds of laboratories reporting 5 or fewer cases per month. A surprising finding was that, although intraoperative PTH testing originally became widely practiced as a point-of-care test, 71% of laboratories performed testing in a central laboratory, 6% in satellite laboratories, and only 23% in operating suites. A survey of methods showed that 33% used the manual QuiCk-Intraoperative test, 47% used the automated Immulite Turbo intact PTH assay, and 20% used other methods. CONCLUSIONS: Intraoperative testing of intact PTH, although relatively new, has come into widespread practice during parathyroid surgery. Service delivery has evolved from a point-of-care model toward a central laboratory model, with this test serving as an illustrative example of factors that affect the balance between point-of-care and laboratory testing.

Canada↗

PubMed2000

The three point vernier alignment or acuity test (3Pt VA test): an analysis of variance.

A very useful clinical vernier acuity or vernier alignment test has been developed in this and associated laboratories over a span of two decades. We seek to refine further this test, to seek internal inconsistencies and to optimize parameters used in a variety of devices and environments. Vernier testing, and many aspects of this work have been considered by numerous able scientists over a long time period (not reviewed here), but none have encountered conditions faced by this group, particularly in the developing world. The three point vernier alignment (acuity) threshold test (3Pt VeA test) employed here has broad applications; it can be used as a clinical test of vision status, for triage, and as a reference standard for vision testing (in general). As one example, if sufficient luminance is employed, the test is applicable in the presence of truly dense media disorders, even advanced leucomas, mature cataracts, intraocular bleeds, as well as combinations of these disorders, with or without a window to the retina. Only retinal and centrally-based neural disorders, eccentricity from fixation, and about 50% of hypermature cataracts affect outcomes. With minor alterations, this test can be employed to assess the visual field. An analysis of variance (ANOVA) was performed on a defined set of parameters, to enable us to understand better the special properties and requirements associated with this test. Results are not significantly altered between ages 10-94 years (not assessed here). Employing settings well above threshold for test spot detection and well separated individual test spots, changes in test spot luminance, or background luminance (or adaptation level), contrast, veiling glare, test spot size, clear and variously degraded images, seem not to affect meaningfully measured outcomes. If an observer can define well a center of gravity for each test spot viewed, he can align the three points with remarkable precision.

Adult↗

PubMed2003

Comparison of disc diffusion & E test methods with agar dilution for antimicrobial susceptibility testing of Haemophilus influenzae.

BACKGROUND & OBJECTIVES: Reliable methods of detection of antimicrobial resistance are of paramount importance in the treatment and management of infections caused by Haemophilus influenzae. The objective of the present study was to compare and evaluate the performance of disc diffusion and E test (Epsilometer test) with agar dilution method for antimicrobial susceptibility testing of H. influenzae. METHODS: A total of 46 isolates of H. influenzae from various invasive sites were included as test strains. Antimicrobial susceptibility testing was performed by Kirby-Bauer disc diffusion method for ampicillin, chloramphenicol, trimethoprim-sulphamethoxazole (TMP-SMZ) and cefotaxime. Minimum Inhibitory Concentration (MIC) determination was performed by E test and agar dilution for the same set of antimicrobials. All tests were performed on Haemophilus test medium (HTM). RESULTS: Disc diffusion showed a very major (2%) and minor (4%) interpretative error with TMP-SMZ and minor interpretative errors to ampicillin (13%) and chloramphenicol (24%) when compared to agar dilution method. E test produced only minor interpretative errors to chloramphenicol (7%) and TMP-SMZ (2%) and no interpretative errors with ampicillin and cefotaxime as against agar dilution. E test showed good agreement with agar dilution for each of the antimicrobial tested. INTERPRETATION & CONCLUSION: Disc diffusion test may be used as a preliminary screen for susceptibility testing of H. influenzae. E test is simple, easy to perform and a reliable method for determination of resistance in H. influenzae. However its cost and limited availability in India may limit its use. The reference agar dilution method can be used reliably in routine susceptibility testing of H. influenzae.

Agar↗

PubMed2004

[Comparison between electrocardiographic test with dobutamine and exercise stress testing on coronary risk stratification].

The exercise testing is still the most common test used to stratify the patients's risk of new events following an acute myocardial infarction, but about 20 to 40% of the patients can not perform it appropriately. Since the electrocardiographic test with dobutamine has proved to be easy and safe, our aim was to evaluate its capacity to predict the results of the exercise testing on patients after an acute myocardial infarction. A total of 210 patients (average of age 60.5+/-11.7 years old and 23.3% females) recovering from a first uncomplicated myocardial infarction, were consecutively included. An electrocardiographic test with dobutamine was performed during the fifth day of admission, and an exercise test during the sixth. The development of chest pain and/or a descending ST segment > or = 1 mm during a test qualified it as positive for ischemia. The sensitivity, specificity, positive and negative predictive values of both tests were determinated, as well as the congruence on their results, a p-value < 0.05 was considered as statistically significative. Whereas 91 patients achieved a positive result on the electrocardiographic dobutamine tests, 54 patients were positive during exercise. On the other hand, both tests came up positive in 49 patients, and negative in 114 patients. The hemodynamic variables were similar during both tests, except in those patients with negative results with both methods, who developed a higher maximal arterial pressure and double product during exercise. Accordingly, the electrocardiographic dobutamine test showed a sensivity 90.17%, a specificity 73%, positive and negative predictive values 54% and 95.8%, respectively, to predict the results of the exercise testing, with a Kappa value of 0.52. In conclusion, the electrocardiographic dobutamine test showed not only to predict the results of the exercise testing adequately with a high negative predictive value, but also to be safe, a useful and simple diagnostic tool for the evaluation of patients after an acute myocardial infarction.

Blood Pressure↗

PubMed1998

Comparison of Multi-Test device skin testing and modified RAST results.

The initial purpose of this study was to determine the potential correlation between allergy test results obtained with the Multi-Test skin testing method and the radioallergosorbent test (RAST) blood test (used as a "standard"). Twenty patients with a history and physical examination findings suggestive of inhalant allergy underwent both a Multi-Test system screen (14 antigens plus histamine and glycerine controls) and RAST testing. The relationship between wheal size and Multi-Test system grade for each antigen and the corresponding RAST class was studied. The correlation between positive Multi-Test system and RAST results was poor, with an average agreement by antigen of 56.26% and overall agreement of 67.86%. However, the overall agreement between negative Multi-Test system results (< or =1+) and negative RAST results (< or =class 1) was 95.15%, with an average agreement by antigen of 83.99%. On the basis of results of this preliminary study, it appears that a negative Multi-Test system result indicates that significant inhalant allergy is unlikely, whereas a positive Multi-Test system result necessitates follow-up with more definitive testing by additional skin testing or RAST.

Humans↗

PubMed1993

Evaluation of the automated 'Enzymen-Test Anti HIV-1 + 2' and 'Enzymen-Test Anti HIV-1/2 selective' for the combined detection and differentiation of anti-HIV-1 and anti-HIV-2 antibodies.

A new, modular automated ELISA (test 1) for HIV-1 and HIV-2 antibody detection and differentiation (Enzymun-Test Anti HIV-1 + 2; anti HIV 1/2 selective, Boehringer Mannheim) was compared with 3 alternative enzyme immunoassays (Abbott recombinant HIV-1/HIV-2 3rd generation EIA, Abbott (test 2); Enzygnost HIV 1 + 2, Behringwerke (test 3); and Wellcozyme HIV recombinant, Murex (test 4)) and Western blot (New LAV I Blot and New LAV II Blot; Diagnostics Pasteur). 380 serum samples from HIV-1 and HIV-2 seropositive patients at different stages of disease, high risk individuals, patients with conditions unrelated to AIDS and from healthy blood donors were used in this evaluation along with 6 seroconversion panels, 6 serum dilution series and 'tricky' sera (repeatedly positive results in ELISA, but negative or undeterminate in Western blot; n = 67). Using the Western blot as reference assay, the overall sensitivity of the four ELISAs was 100%. Test 4 showed the highest sensitivity for antibody detection in seroconversion and dilution series. A high specificity was achieved with test 1 (100%) and test 2 (99.4%). A relatively high rate of false positive results were obtained with test 2 (n = 12) and test 3 (n = 10) by testing 'tricky' sera or samples obtained from healthy blood donors. In comparison to Western blot, a clear differentiation between HIV-1 and HIV-2 antibody serum samples was achieved with the Enzymun-Test. The results of the present study show that the Enzymun-Test provides reliable selective HIV-1 and HIV-2 antibody detection at a cost which is significantly lower than the costs of Western blot tests. Furthermore, the evaluation of test 1 suggests, that it is a highly specific assay for HIV antibody detection.

AIDS Serodiagnosis↗

PubMed1994

Evaluation of different sperm function tests as screening methods for male fertilization potential--the value of the sperm migration test.

OBJECTIVE: To assess the value of different sperm function screening tests in predicting fertilization. DESIGN: Prospective study. SETTING: Academic tertiary referral center for fertility treatment. PATIENTS: Ninety-five couples attending for initial screening and IVF-ET. Only cycles where three or more grade I oocytes were collected were included, and patients with endometriosis were excluded. INTERVENTIONS: Each patient had a standard semen analysis, cervical mucus (CM) penetration test, hypo-osmotic swelling test, and sperm migration test performed between 4 and 8 weeks before IVF-ET. MAIN OUTCOME MEASURES: The correlation between sperm function test results and the percentage of fertilized oocytes and the power of the tests to predict fertilization. RESULTS: The sperm migration test correlated highly with fertilization rate (r = 0.62) and was most useful in identifying the group of patients likely to achieve fertilization (Odds ratio [OR] 0.07, confidence interval [CI] 0.02 to 0.2). The CM penetration test showed a moderate correlation with fertilization rate (r = 0.45) and some predictive power (OR 0.37, CI 0.13 to 1.00). Sperm concentration, but not motility or normal morphology, showed slight correlation with fertilization rate (r = 0.28) but the combination of normal semen parameters did not distinguish patients likely to achieve fertilization (OR 1.51, CI 0.62 to 3.65). The hypo-osmotic swelling test did not correlate with fertilization rate (r = 0.21). CONCLUSIONS: This study evaluated the predictive power of several simple tests available for use in most laboratories as screening tests of sperm fertilization potential. Apart from sperm concentration, normal traditional semen characteristics were of little clinical benefit. The hypo-osmotic swelling test had no predictive power. The CM penetration test correlated with fertilization rate but might be difficult to perform routinely as a continuous supply of suitable CM would be required. The sperm migration test proved to be the best discriminator of sperm fertilization potential and should be considered as a first level screening test in the assessment of male fertility.

Cervix Mucus↗

PubMed2003

Physical examination of the knee: a review of the original test description and scientific validity of common orthopedic tests.

OBJECTIVES: To present the original descriptions of common orthopedic physical examination maneuvers of the knee and then to review the literature to support the scientific validity of these tests. DATA SOURCES: MEDLINE (1970-2000) searches were performed, as were reviews of various musculoskeletal examination textbooks that describe physical examination maneuvers of the knee. These references were then reviewed for additional references and crossed back to the original description (when possible) of these named tests. STUDY SELECTION: All articles that discussed the sensitivity and specificity of the physical examination maneuvers were extracted. This information was reviewed for accuracy and then summarized. DATA EXTRACTION: Multiple MEDLINE and text searches were performed by using the terms of the test maneuver, the joint tested, and the term physical examination. Any article with this information was reviewed until the article describing the original description was found. Articles dating from that original article to the present were reviewed for information on the sensitivity and specificity of the test. DATA SYNTHESIS: Literature reviewing the sensitivity and specificity of the tests reviewed is summarized in text and table form. The Lachman test seems to be very sensitive and specific for the detection of anterior cruciate ligament tears. For posterior cruciate ligament tears, the posterior drawer test is also very sensitive and specific and is enhanced with other tests, such as the posterior sag sign. For meniscal tears, the McMurray test is very specific but has a very low sensitivity, whereas joint line tenderness has fairly good sensitivity but lacks good specificity. Although collateral ligament testing seems to be sensitive and specific, there is a lack of well-designed studies that scientifically validate the sensitivity and specificity of these tests. Common tests for patellofemoral pain and patellar instability lack sensitivity when correlated with pathologic operative findings. CONCLUSIONS: Most physical examination tests could be referenced back to an original description, with variable information on the sensitivity and specificity along with other information about the validity of these tests in clinical practice. To standardize how physical examinations are performed and compared, they should follow the original description or agreed-on standards. In addition, the significance of a physical examination finding must be understood to ensure that patients with knee complaints are accurately diagnosed and properly treated.

Biomechanical Phenomena↗

PubMed1999

HIV testing practices of Zimbabwean physicians and their perspectives on the future use of rapid on-site tests.

To improve HIV testing procedures, rapid on-site HIV tests have been introduced in Zimbabwe. At present, little is known about physicians' perspectives on the potential use of rapid tests in their clinics or about their current laboratory-based testing practices. In a sample of 63 general practitioners in Harare, this study found physicians were generally testing individuals, not couples, and an important reason for suggesting a patient be tested was medical symptoms; frequent reasons for patients requesting the test were insurance purposes, being about to get married or having suspicions about a partner. A primary deterrent to physicians testing patients, even when patients requested it, was fear of traumatizing them. Fifty-six per cent of the physicians believed rapid tests would increase the number of HIV tests they performed; significant associations were found between this belief and whether physicians ever chose not to test patients they suspected were HIV-positive (a positive association) and whether they chose not to test specifically out of fear that patients would commit suicide (a negative association). Prior to any expansion of testing with rapid tests, training in counselling and confidentiality measures is essential, given that over half the medical personnel providing counselling to these physicians' patients had received no training in pre- and post-test HIV counselling.

Attitude of Health Personnel↗

PubMed1994

Levels of HIV testing and low validity of self-reported test results among alcoholics and drug users.

OBJECTIVES: To evaluate HIV testing behavior, validity of self-reported serostatus, and intention to test among alcoholics and drug users entering treatment. DESIGN: Longitudinal cohort study. METHODS: A total of 952 clients voluntarily entering three outpatient and two inpatient public alcohol treatment centers in San Francisco were enrolled. Seventy-six per cent were men, 50% black, 81% had used both alcohol and drugs during the last year, 43% had injected drugs and 9% of the men were homosexual. Subjects completed an interviewer-administered questionnaire and blindly-linked HIV-antibody test at entry and after 1 year (81% follow-up). RESULTS: Fifty-seven per cent of subjects reported that they had previously sought HIV testing. Factors associated with HIV testing included homosexual contact, injecting drug use, having a partner who had been tested, and using condoms. Hispanics were the least likely of all ethnic groups to report testing. Of 60 subjects with HIV antibodies, 47 (78%) said they had already been tested; however, 19 (40%) inaccurately reported that their serostatus was negative and another four (9%) had no collected their test results. Blacks were much more likely than other groups to misreport or be unaware of their HIV status. Only half of the 68% who said they planned to be tested during the following year did so. Five (42%) out of 12 HIV-positive individuals who were unaware of, or misreported their serostatus at baseline, and who sought another HIV test during the follow-up year continued to report themselves as uninfected. CONCLUSIONS: A large proportion of clients attending public alcohol treatment centers report having been HIV tested, much greater than that observed in other populations. However, misreporting of HIV test results was very common among seropositive subjects. Alcohol and drug treatment programs for this high-risk population should include interventions to optimize use of HIV testing for prevention and treatment, and improve understanding of test results.

Adolescent↗

PubMed2001

Determination of the antibacterial efficacy of several antiseptics tested on skin by an 'ex-vivo' test.

There are many skin antiseptics commercially available. Although their antibacterial activity has often been well studied, their potential effectiveness on skin remains poorly documented. To date, in-vivo protocols designed for the testing of the antimicrobial efficacy of antiseptics cannot use, for ethical reasons, pathogenic bacteria or new formulations whose toxicity in human subjects is unknown. An 'ex-vivo' test was recently developed to overcome these problems. Freshly excised human skin from abdominal or breast reduction was placed in a diffusion cell containing a maintenance medium in the recipient compartment. A bacterial inoculum was then applied to the stratum corneum and, after a drying step, antiseptic formulations were evaluated for their antimicrobial activity. Several micro-organisms were investigated: - Staphylococcus aureus, methicillin-resistant S. aureus (MRSA), Enterococcus faecalis, vancomycin-resistant Ent. faecium (VRE), S. epidermidis, Pseudomonas aeruginosa and Escherichia coli--with several biocides--para-chloro-meta-xylenol (PCMX, active compound of Dettol), povidone iodine, triclosan (in isopropanol) and chlorhexidine. Results from the ex-vivo test were compared with results obtained in suspension and glass-carrier tests. The bactericidal activity of the biocides depended upon the test performed and results were generally significantly different from one method to the other. All biocides tested in the suspension test achieved >4 log10 reduction in viable bacterial concentrations, apart from povidone iodine tested against Ent. faecalis and VRE. The antibacterial activity of biocides tested in the glass-carrier test was significantly lower than in the suspension test, with the exception of triclosan in isopropanol, which was as effective in both suspension and glass-carrier test. In the ex-vivo test, triclosan in isopropanol achieved a log10 reduction in viable bacterial concentration of 1.105-1.771 (with the exception of P. aeruginosa with 0.758 log10 reduction). PCMX, povidone iodine and chlorhexidine achieved log10 reductions in viable bacterial concentration of 0.303-0.901. Chlorhexidine tested against P. aeruginosa produced a 1.94 log10 reduction in concentration. These results confirm previous observations about the need for testing the antimicrobial activity of antiseptics on skin surface to determine their in-situ efficacy and encourage further the use of the ex-vivo protocol.

Anti-Infective Agents, Local↗

PubMed1983

EDTA-treated plasma in the rapid plasma reagin card test and the toluidine red unheated serum test for serodiagnosis of syphilis.

Both the rapid plasma reagin (RPR) 18-mm circle card test and the toluidine red unheated serum test (TRUST) were designed to be more rapid than the Venereal Disease Research Laboratory slide test for the serodiagnosis of syphilis. The RPR card test, although originally designed as the teardrop card test for use with plasma, has received recognition from the Centers for Disease Control as a standard test for syphilis for use with serum samples only. In this study, 132 EDTA plasma-serum pairs were tested in both the RPR card test and TRUST immediately after the blood was drawn and the serum or plasma was separated from the cellular constituents of the blood. The plasma samples were further tested at 24-h intervals of storage at 25 and 4 degrees C for 72 h. Special attention was paid to any increase in roughness in nonreactive specimens. The greatest increase in roughness (16.7%) was seen with the TRUST after 72 h at 25 degrees C. An additional 174 plasma-serum pairs were tested after 18 h of storage at 25 degrees C. Comparisons of the results of the 306 serum specimens with their corresponding plasma pairs gave 99.0% qualitative agreement for both tests. Quantitative agreement +/- 1 dilution between serum-plasma pairs tested within 18 h was 92.1% (35 of 38) for the RPR card test and 94.1% (32 of 34) for the TRUST. Our results with plasma from blood drawn with EDTA as the anticoagulant were comparable with results with serum specimens for both tests when plasma specimens were tested within 18 to 24 h.

Antibodies↗

PubMed2006

Evaluation of the disintegration properties of commercial famotidine 20 mg orally disintegrating tablets using a simple new test and human sensory test.

The purpose of this study was to demonstrate the usefulness and broad-applicability of a simple disintegration test method for orally disintegrating tablets (ODT). Eight types of commercial famotidine 20 mg orally disintegrating tablets with different physical properties (formulation, manufacturing method, tablet weight, shape, diameter, thickness, etc.), were used. Disintegration times of these tablets were evaluated employing human sensory test, conventional disintegration test, and the new proposed disintegration test. The human sensory test was performed in 5 healthy volunteers. In the conventional disintegration test, the disintegration apparatus described in the Japanese Pharmacopeia (JP 1(st)) was used. Our proposed new test which is characterized by a rotating shaft with a low weight (10, 15 g) and rotation speed (10, 25, 50 rpm) was evaluated using tablets with and without storage under severe conditions (60 degrees C/75%RH for 1 week). The disintegration times of famotidine 20 mg orally disintegrating tablets in human sensory test varied from 9 to 32 s. In contrast, disintegration times in the conventional test were prolonged to over 300 s. Disintegration times in the new proposed test were close to those in human sensory test. Especially, when the new test was conducted with 15 or 10 g weight and 25 rpm, the slope (human sensory test vs. new proposed test) was almost 1. We were able to demonstrate that the new proposed test was useful to estimate the actual human disintegration time.

Administration, Oral↗