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C Prontera

Publications and source records attributed to C Prontera.

At least 37 records · Page 2Linked to original sources

Serum soluble interleukin-2 receptor assay in epithelial ovarian cancer.

Preoperative serum soluble interleukin-2 receptor (sIL-2R) and CA 125 levels were measured in 183 patients with ovarian masses undergoing laparotomy. Serum sIL-2R levels were higher in the 54 patients with epithelial ovarian cancer than in the 129 patients with benign ovarian diseases (p < 0.0001). Elevated serum levels of sIL-2R (> or = 71 U/ml) and CA 125 (> or = 83 U/ml) were found in 79.6 and 77.8% of patients with epithelial ovarian cancer, respectively. Serum sIL-2R and CA 125 positivity rates correlated with the FIGO stage (p = 0.0033 and p = 0.0001, respectively). Raised serum levels of sIL-2R and CA 125 were detected in 11.6 and 7.0% of patients with benign ovarian diseases, respectively. The combination sIL-2R or CA 125 had a sensitivity of 88.9%, and the association sIL-2R and CA 125 had a specificity of 98.4% for epithelial ovarian cancer. As for the 16 patients with this malignancy who were serially monitored during and after chemotherapy, changes in sIL-2R and CA 125 levels correlated with the clinical course of disease in 62.3 and 94.3% of 53 instances, respectively. In conclusion, the serum sIL-2R assay could represent a useful adjunctive tool for the differential diagnosis of ovarian masses, while it seems to be of limited benefit for monitoring the response to chemotherapy and follow-up of patients with epithelial ovarian cancer.

Adolescent↗

The concomitant determination of different tumor markers in patients with epithelial ovarian cancer and benign ovarian masses: relevance for differential diagnosis.

The serum levels of CA 125 (cutoff limit, 65 U/ml), CA19.9 (cutoff, 40 U/ml), CA 15.3 (cutoff, 32 U/ml), CA72.4 (cutoff, 3.8 U/ml), and TATI (cutoff, 22 ng/ml) were preoperatively measured in 90 patients with epithelial ovarian cancer and in 254 patients with benign ovarian pathology. CA125 had a sensitivity of 75.6%, a specificity of 86.6%, and a diagnostic accuracy of 83.7% for epithelial ovarian cancer; CA19.9 had a sensitivity of 35.6%, a specificity of 81.1%, and a diagnostic accuracy of 69.2%; CA15.3 had a sensitivity of 57.1%, a specificity of 93.9%, and a diagnostic accuracy of 84.6%; CA72.4 had a sensitivity of 70.7%, a specificity of 91.8%, and a diagnostic accuracy of 86.2%; and TATI had a sensitivity of 47.3%, a specificity of 95.3%, and a diagnostic accuracy of 82.9%. CA 125 was the most sensitive marker for nonmucinous tumors, while CA19.9 and CA72.4 were the antigens more frequently expressed by mucinous malignancies. The sensitivities of serum CA 125 (81.1% vs 50.0%; P = 0.01) and TATI (55.2% vs 18.8%; P = 0.02) were higher in patients above 50 years of age than in younger patients while specificities were quite similar in both age groups. The association of serum CA125 and CA19.9 had a significantly higher sensitivity (93.2% vs 81.1%; P = 0.03) and a slightly lowered specificity (78.9% vs 86.0%; P = 0.46) than CA125 assay alone in the differential diagnosis of ovarian masses in patients above 50 years of age.

Adenocarcinoma↗

The concomitant determination of different serum tumor markers in epithelial ovarian cancer: relevance for monitoring the response to chemotherapy and follow-up of patients.

The levels of CA125, CA19.9, CA15.3 CA72.4, and TATI were serially measured during and after chemotherapy in 43 patients with epithelial ovarian cancer having elevated concentrations of one or more of the antigens before initial surgery. The value of 35 U/ml was chosen as cutoff level of CA125 for the monitoring of disease. Changes in the serum levels of CA125, CA19.9, CA15.3, CA72.4, and TATI correlated with the clinical course of disease in 87.4% of 215, 76.3% of 80, 71.3% of 122, 76.0% of 167, and 48.5% of 101 instances, respectively. After the sixth course of monthly primary chemotherapy, elevated antigen levels were strong predictors of persistent disease, while normal antigen values were associated with both positive and negative second-look findings. It is worth noting that antigen levels above the cut-off limits before the third course, but still in the normal range after the sixth course, seemed to be predictive of positive second-look findings. Among patients with elevated antigen levels at diagnosis, clinical detection of neoplastic progression after treatment was stopped was preceded by an elevation of serum CA125 in 93.3% of 15 patients, of serum CA19.9 in 80.0% of 5 patients, of serum CA15.3 in 66.7% of 9 patients, of serum CA72.4 in 81.8% of 11 patients, and of serum TATI in 40% of 10 patients. In patients with positive CA125 assay at diagnosis, the concomitant evaluation of the other antigens did not seem to be of additional benefit for monitoring epithelial ovarian cancer. However, the measurement of the other tumor markers could represent an interesting biochemical tool for the management of patients with negative CA125 assay. In particular the evaluation of serum CA19.9 or CA72.4 could be very useful in the monitoring of patients with mucinous ovarian cancer, which often fails to express CA125 antigen.

Antigens, Tumor-Associated, Carbohydrate↗

Combined evaluation of serum CA 125 and CAM 29 in patients with epithelial ovarian cancer.

We examined 92 patients with epithelial ovarian cancer and 262 patients with benign ovarian diseases undergoing laparotomy. On the basis of a nonparametric method, antigen levels corresponding to prefixed 95% specificity values in a group of 674 women with benign gynecologic diseases were taken as cutoff limits (88.8 U/ml for CA 125 and 13.7 U/ml for CAM 29). Moreover, CA 125 and CAM 29 levels were measured serially during and after chemotherapy in 26 women selected from the patients with advanced epithelial ovarian cancer. At diagnosis, serum CA 125 was as sensitive as serum CAM 29 for nonmucinous tumors, but more sensitive than serum CAM 29 for mucinous tumors. The association of the two markers seemed to give no advantage over the CA 125 assay alone in the diagnosis of epithelial ovarian cancer. In monitoring the response to chemotherapy and follow-up of patients with epithelial ovarian cancer, changes in CA 125 levels correlated with the clinical course of disease better than changes in CAM 29 levels, and the serum CA 125 assay was more reliable than the serum CAM 29 assay in the early detection of tumor progression. In conclusion, serum CAM 29 did not seem to represent a complementary assay to serum CA 125 in the management of patients with epithelial ovarian cancer.

Adolescent↗

O6-methylguanine inhibits the binding of transcription factors to DNA.

To study the effect of methylation of O6-guanine on the binding of cellular factors to different DNA sequences, modified oligonucleotides were constructed, in which O6-Methylguanine (O6-MeG) replaced some guanines. The DNA sequences utilized were: the region of the c-fos promoter containing the binding site for serum response factor (SRF); the region of the HIV LTR containing two binding sites for the transcription factor NF kappa B; the region of the HIV LTR containing three binding sites for the cellular factor sp1. After incubation of labeled oligonucleotides, either unmodified or containing O6-MeG, with nuclear extracts obtained from different cell lines, gel retardation assays indicated that the presence of O6-MeG resulted in inhibition of binding of cellular factors to DNA sequences located in the promoter regions of genes. This inhibition was not the same for all modified oligonucleotides but dependent on the position in which O6-MeG was located. The results obtained indicate that alkylation of O6-guanine affects the binding of transcription factors and thereby possibly the regulation of genes expression.

Alkylation↗

Comparison of tumor-associated trypsin inhibitor (TATI) with CA125 as a marker for diagnosis and monitoring of epithelial ovarian cancer.

Preoperative serum levels of CA125 and tumor-associated trypsin inhibitor (TATI) were measured in 220 patients undergoing laparotomy for adnexal masses. Of the 57 patients with epithelial ovarian cancer. 86% had serum CA125 higher than 35 kU/l and 81% higher than 65 kU/l while 51% had serum TATI above 22 micrograms/l. In eight patients with mucinous ovarian malignancies, serum levels of CA125 were above 65 kU/l in 6 cases while serum TATI was above 22 micrograms/l in 4 cases. Of the 163 patients with benign ovarian masses, 41% had serum CA125 levels above 65 kU/l and 17% above 65 kU/l whereas serum TATI was above 22 micrograms/l in 6%. In 11 cancer patients having elevated levels of both CA125 and TATI at diagnosis, the serum concentrations of these antigens were periodically measured during and after treatment. Changes in CA125 and TATI levels correlated with the clinical course in 84% and 37% of the instances, respectively. After the sixth course of chemotherapy, the diagnostic accuracy of the markers in the evaluation of the disease status at second-look laparotomy was 55% for CA125 with a cut-off level of 35 kU/l, 36% for a cut-off level of 65 kU/l, 55% for TATI, and 66% for the combination of CA125 and TATI with cut-off levels of 65 kU/l and 22 micrograms/l. CA125 is the most sensitive marker for epithelial ovarian cancer, but the concomitant measurement of TATI could be of benefit in both differential diagnosis of adnexal masses and monitoring of response of epithelial ovarian cancer to treatment.

Antigens, Tumor-Associated, Carbohydrate↗

A new chemiluminescence immunoassay for triiodothyronine and thyroxine: evaluation using quality control sera assayed in an interlaboratory survey.

A recently developed chemiluminescence immunoassay system (LIA-mat) for triiodothyronine and thyroxine, set up by Byk-Sangtec Diagnostica (Dietzenbach, Germany), has been evaluated and compared with radioimmunoassays and with a chemiluminescence enhanced enzyme immunoassay (Amerlite), using control materials circulated in a national interlaboratory quality control, as well as patient sera. The LIA-mat assays are competitive methods which use coated monoclonal antibodies and triiodothyronine- or thyroxine-ABEI (aminobutylethylisoluminol) conjugate as tracers. The working range of LIA-mat T3 (computed from the within-assay precision profile) extended from 1.4 to 12.3 nmol/l; the between-assay precision was 8.1 - 19.3 CV%. Regression analysis of the LIA-mat T3 results (y) against the consensus means (x) of the participants in the national interlaboratory survey yielded: y = -0.14 + 1.05 x, r = 0.95. The working range of LIA-mat T4 extended from 33 to 515 nmol/l; the between-assay precision was 5.4 - 9.2 CV%. An excellent agreement was found between LIA-mat T4 results (y) and the consensus means (x) of the laboratories participating in the national interlaboratory survey (y = 3.79 + 1.02 x, r = 0.98).

Dose-Response Relationship, Drug↗

CAM26, CAM29 and mucin-like carcinoma associated antigen in epithelial ovarian cancer.

The levels of CA125 (reference values [RVs] 35 U/mL and 65 U/mL), CA15.3 (RV = 32 U/mL), Mucin-like carcinoma associated antigen (MCA; RV = 15 U/mL), CAM26 (RV = 75 U/mL) and CAM29 (RV = 15 U/mL) were preoperatively assayed in blood samples drawn from 42 patients with ovarian carcinoma and 101 patients with benign ovarian pathology undergoing laparotomy at the Department of Gynecology and Obstetrics of the University of Pisa. With 65 U/mL as RV, CA125 had a sensitivity (SE) of 80.9% and a specificity (SP) of 89.1% for ovarian carcinoma; with 35 U/mL as RV, CA125 had a SE of 85.7% and a SP of 66.3%; CA15.3 had a SE of 57.1% and a SP of 96.0%; MCA had a SE of 59.5% and a SP 86.1%; CAM26 had a SE of 21.4% and a SP of 96.0%, CAM29 had a SE of 64.3% and a SP of 97.0%. The association of CA125 with each of other antigens did not improve the SE of CA125 assay alone in the detection of patients with ovarian carcinoma. In conclusion, the present data showed that the measurement of CA15.3, MCA and CAM26 did not give any additional information with respect to CA125 assay in the diagnosis of ovarian carcinoma. The good SE and the very good SP and diagnostic accuracy of CAM29 could suggest further investigation in order to evaluate the role of this antigen in the management of patients with this malignancy.

Adenocarcinoma↗

A comparison of pretreatment serum levels of four tumor markers in patients with endometrial and cervical carcinoma.

CA125 (reference value [RV] = 35 U/mL), CA50 (RV = 20 U/mL), CA72.4 (RV = 3.8 U/mL) and SCC (RV = 3.6 ng/mL) levels were retrospectively assayed in blood samples collected at diagnosis from 42 patients with endometrial carcinoma, 45 patients with cervical carcinoma and 68 patients with benign uterine pathology as controls. Among the patients with endometrial carcinoma. CA50 was the antigen with the highest sensitivity (SE) (34.4%) followed by CA125 (26.2%), CA72.4 (21.9%) and SCC (16.7%). The incidence of elevated serum CA125 and CA72.4 levels was significantly greater in advanced stages than in early ones (66.7% vs 19.4%, p = 0.032 for CA125; 66.7% vs 11.5%, p = 0.012 for CA72.4), while CA50 positivity was not significantly correlated with the extent of disease (50% in advanced stages vs 30.8% in early ones, p = 0.38). Among the patients with cervical carcinoma, CA125 and CA50 respectively showed a SE of 33.3% and of 42.9% for adenocarcinoma, while SCC had a SE of 33.3% and of 42.9% for squamous cell adenocarcinoma; in particular among the patients with squamous cell carcinoma, the incidence of elevated SCC levels was correlated with the extent of tumor (57.1% in advanced stages vs 12.5% in early ones, p = 0.013). In conclusion, CA50 and CA125 were the most sensitive tumor markers in both endometrial carcinoma and cervical adenocarcinoma, while SCC was the most reliable antigen for squamous cell carcinoma of the cervix. Because of the affinity of SCC, CA50 and CA125 for different histological types of cervical carcinoma, the combined evaluation of SCC with CA50 or CA125 showed an increased SE with respect to each marker alone.

Adenocarcinoma↗

A comparison of the usefulness of serum measurements of CA 125, CA 50 and TATI in patients with malignant and benign gynecological pathology.

CA 125, CA 50 and Tumor Associated Trypsin Inhibitor (TATI) levels were assayed in blood samples drawn at diagnosis from 149 patients with malignant or benign gynecological pathology. CA 125 serum levels greater than 35 U/ml and 65 U/ml were respectively found in 34/38 (89.5%) and in 33/38 (86.8%) patients with ovarian carcinoma, in 17/61 (27.9%) and in 6/61 (9.8%) with benign ovarian pathology, in 6/30 (20.0%) and in 1/30 (3.3%) with cervical carcinoma, in 6/20 (30.0%) and in 6/20 (30.0%) with endometrial carcinoma. TATI serum levels greater than 22 ng/ml were observed in 17/38 (44.7%) patients with ovarian carcinoma, in 3/61 (4.9%) with benign ovarian pathology, in 1/30 (3.3%) with cervical carcinoma and in 3/20 (15.0%) with endometrial carcinoma. CA 50 serum levels greater than 20 U/ml were found in 11/38 (28.9%) patients with ovarian carcinoma, in 19/61 (31.1%) with benign ovarian pathology, in 7/30 (23.3%) with cervical carcinoma and in 6/20 (30%) with endometrial carcinoma. This study confirmed that CA 125 is the most reliable marker for ovarian carcinoma; however TATI could have a role in the diagnostic evaluation of adnexal masses, because of its very good specificity, CA 125 and CA 50, but not TATI, could be of some benefit in the management of endometrial and cervical carcinoma.

Antigens, Tumor-Associated, Carbohydrate↗

A comparative evaluation of the ability of serum CA 125, CA 19-9, CA 15-3, CA 50, CA 72-4 and TATI assays in reflecting the course of disease in patients with ovarian carcinoma.

The Authors compared the ability of serum CA 125, CA 19-9, CA 15-3, CA 50, CA 72-4 and Tumor-Associated Trypsin Inhibitor (TATI) assays in reflecting the disease course in a group of 27 patients with ovarian carcinoma. Before initial surgery, elevated levels of CA 125 (greater than 65 U/ml) were found in 27 patients, of CA 19-9 (greater than 40 U/ml) in 7, of CA 15-3 (greater than 32 U/ml) in 17, of CA 50 (greater than 20 U/ml) in 7, of CA 72-4 (greater than 3.8 U/ml) in 20, and of TATI (greater than 22 ng/ml) in 13. For each marker, only patients with elevated antigen levels at diagnosis were considered. CA 125, CA 19-9, CA 15-3, CA 50, CA 72-4 and TATI levels correlated with disease regression, stability or progression in 123/147 (83.7%), 24/34 (70.6%), 57/87 (65.5%), 26/38 (68.4%), 87/120 (72.5%), 33/75 (44.0%) instances respectively. Alterations in CA 125 levels correlated with disease status better than alterations in each other antigen levels. However serial measurement of the other tumor markers could be of help in the monitoring of patients with normal CA 125 values before initial surgery.

Antigens, Tumor-Associated, Carbohydrate↗

Effect of 5-HT1A agonists on stress-induced deficit in open field locomotor activity of rats: evidence that this model identifies anxiolytic-like activity.

Deficits in locomotion and exploratory behaviour in an open field were induced in rats by restraint for 2 hr, 23 hr before testing. Diazepam, 0.62 and 1.25 mg/kg, intraperitoneally (i.p.), 15 min before testing, reversed the stress-induced reduction in locomotion; 1.25 mg/kg also attenuated the effect of stress on exploration (rearing and object exploring). Diazepam did not affect the activity of controls. A putative anxiogenic compound, pyrazoloquinoline (CGS 8216, 10 mg/kg administered 30 min before testing), also markedly reduced locomotion and exploration and the effect was reversed by 2.5 mg/kg diazepam, 15 min before testing. Buspirone, 0.1 mg/kg subcutaneously (s.c.) 15 min before testing, significantly attenuated the effect of stress on locomotion and exploration but had no effect in controls. Larger doses (0.5 and 1.0 mg/kg) markedly reduced the behavioural measures in controls and did not modify or enhance the effect of stress. 8-Hydroxy-2-(di-n-propylamino)tetralin (8-OH-DPAT), 0.25 and 0.5 mg/kg (s.c.), 1 hr before testing, significantly attenuated the reduction in locomotion without affecting rearing and object-exploring in stressed rats. At doses from 0.125 to 0.5 mg/kg, 8-OH-DPAT reduced exploration in control rats. Two hr after restraint (corresponding to 21 hr before testing in the open field) 8-OH-DPAT, 0.125 to 2 mg/kg (s.c.), did not modify the open field deficits, caused by stress. In these treatment conditions, 0.5 and 2 mg/kg 8-OH-DPAT reduced locomotion and exploration in control rats.(ABSTRACT TRUNCATED AT 250 WORDS)

8-Hydroxy-2-(di-n-propylamino)tetralin↗

Evidence that central 5-hydroxytryptaminergic neurones are involved in the anxiolytic activity of buspirone.

1. A two-compartment exploratory test was used to assess the role of central 5-hydroxytryptaminergic neurones in the anxiolytic activity of buspirone in rats. 2. Buspirone 0.1 mg kg-1, administered subcutaneously 15 min before testing, significantly increased black-white transitions (BWT) in control rats but had no effect in animals injected intracerebroventricularly one week before with 150 micrograms 5,7-dihydroxytryptamine (in 20 microliters). 3. Infusion of buspirone in the median raphe (but not in the dorsal raphe) significantly enhanced BWT, at doses from 1 micrograms to 10 micrograms (in 0.5 microliters). Buspirone 5 and 10 micrograms, but not 1 microgram, administered in the median raphe, significantly enhanced motor activity of rats during the first 10 min of testing in the activity cages. 4. The effect on BWT of 5 micrograms buspirone in the median raphe was completely antagonized in animals which had received either 5,7-dihydroxytryptamine intraventricularly, 150 micrograms (in 20 microliters), one week before or an infusion of 0.1 microgram (in 0.5 microliter) (-)-propranolol in the same area 5 min before. (-)-Propranolol infused in the median raphe did not modify the effect of buspirone on locomotion. 5. Infusion of 5 micrograms buspirone (in 0.5 microliter) in the median raphe significantly enhanced punished responses in a conflict test with no effect on unpunished responding. Buspirone infused in the dorsal raphe had no effect on punished or unpunished responding over a wide dose range. 6. The results indicate that at the relatively low dose used in the present study buspirone produces an anxiolytic effect by acting on central 5-hydroxytryptaminergic neurones. It is likely that activation of 5-hydroxytryptamine1A-receptors in the median raphe is involved.

8-Hydroxy-2-(di-n-propylamino)tetralin↗

External quality assurance of the carcinoembryonic antigen (CEA) assay: main findings in six years' experience.

In 1984 we initiated a national external quality assessment (EQA) program (supported by the Italian National Research Council, CNR) for the CEA assay; at present, about 200 Italian laboratories are participating in the program. The laboratories assayed the quality control (QC) samples according to their routine procedures and returned the results together with the name of the method/kit they used. The collected results were computer-processed and reports were sent back to the participants. A significant reduction of the CVt (mean between-laboratory agreement) of the CEA assay was observed throughout the EQA survey (from 35% in 1985 to 20-25% in the last cycles). In order to better clarify the differences in variability observed in the first QC cycles against the last ones, we used the ANOVA technique to evaluate the components of variability. The improvement in between-laboratory agreement was mainly due to the reduction of the between-kit component (from 30.5% to 15.2%), rather than to the smaller decrease observed for the within-kit variability (from 18.4% to 14.0%). The results reported for QC samples from different materials showed differences in the between-lab variability and substantial changes of the kit biases, thus suggesting a different specificity of the antibodies used in the various method/kits against different families of CEA molecules. Considerable uncertainty was also encountered in the clinical classification of low pathological samples, which seems mainly due to the variability in cut-off values used by the laboratories for the clinical assessment of the same analytical results. Our data indicate a progressive increase in the reliability of CEA determination during our study and confirm that EQA has improved the reliability of analysis carried out by the participating laboratories, thus stimulating the kit manufacturers to provide more reliable products.

Antibody Specificity↗

Serum preoperative vascular endothelial growth factor (VEGF) in epithelial ovarian cancer: relationship with prognostic variables and clinical outcome.

Substantial experimental and clinical evidence links tumor growth, progression and metastatic potential with neoangiogenesis. This process is modulated by several angiogenic growth factors, such as vascular endothelial growth factor (VEGF). Little data are currently available on serum VEGF levels in cancer patients. In the present retrospective investigation preoperative serum VEGF was higher in 53 patients with epithelial ovarian cancer than in 25 patients with benign ovarian disease as controls (median, range: 229.7, 23.5-1807.5 pg/ml versus 140.3, 14.7-1038.7 pg/ml, p = 0.034). With regard to FIGO stage, antigen values were significantly elevated in stage III-IV (p = 0.027) but not in stage I-II ovarian cancer patients when compared to controls. In patients with advanced disease preoperative serum VEGE was significantly related to the presence of ascites (p = 0.013), but not to common prognostic variables, response to chemotherapy and survival. In conclusion, preoperative serum VEGF assay reflects tumor progression and ascites generation in epithelial ovarian cancer, but it seems to have a limited predictive and prognostic value in patients with advanced disease.

Adult↗

CA 195: a new monoclonal antibody-defined Lea blood group-related tumor marker in patients with epithelial ovarian cancer.

The levels of CA 125 (reference values [RV]s = 35 U/mL and 65 U/mL), CA 19.9 (RV = 40 U/mL), CA 50 (RV = 20 U/mL) and CA 195 (RVs = 10.5 U/mL and 15 U/mL) were measured in blood samples collected before laparotomy from 71 patients with ovarian carcinoma and 204 patients with benign ovarian pathology as controls. CA 125 levels greater than 35 U/mL were observed in 53/61 patients with non-mucinous carcinomas and in 6/10 with mucinous ones, while antigen levels above 65 U/mL were detected in 50/61 patients with non-mucinous malignancies and in 6/10 with mucinous ones; therefore mucinous tumors expressed this antigen less frequently than non-mucinous ones. Elevated CA 19.9 levels were found in 15/61 patients with non-mucinous malignancies and in 8/10 with mucinous ones. Raised CA 50 levels were observed in 13/50 patients with non-mucinous cancers and in 7/8 with mucinous ones. CA 195 values were greater than 10.5 U/mL and 15 U/mL respectively in 20.0% and in 15.0% of 40 patients with non-mucinous tumors, while antigen levels were above 10.5 U/mL and 15 U/mL respectively in 75.0% and 62.5% of 8 patients with mucinous carcinomas. Therefore, CA 19.9, CA 50 and CA 195 highly correlated with mucinous histotype. The results of CA 195 and CA 19.9 determinations were very similar because of the closely related: structures of the two epitopes.(ABSTRACT TRUNCATED AT 250 WORDS)

Adenocarcinoma↗

Analytical and clinical assessment of a commercial kit for the simultaneous determination of free thyroxine and thyrotropin.

The SimulTRAC FT4/TSH kit (Becton Dickinson), allowing a simultaneous determination of free thyroxine (FT4) and thyrotropin (TSH), was assessed in terms of analytical quality and clinical performance. The results of a multicenter trial were included in this study to obtain a more complete and reliable information. The current validation procedures (ie evaluation of analytical imprecision and sensitivity, between-kit comparison of estimates and--limited to TSH--check of response linearity on dilution) demonstrated quite acceptable analytical characteristics for both the FT4 and the TSH tests. The diagnostic sensitivity and predictive value were derived for separate and combined tests from a relatively large number of cases (ie 401 euthyroids, 127 overt and 48 subclinical hypothyroids, 205 overt and 80 compensated hyperthyroids). The TSH test proved more effective than FT4 in discriminating both overt and subclinical dysfunctions, and, in this respect, the test association was found to add a little advantage--if any. However, the extension of the concepts of diagnostic efficiency to any combination of test results--favoured by their production in a single assay--provides a basis to establish diagnostic protocols and to predict costs and benefits of medical actions.

Evaluation Studies as Topic↗