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PubMed1997

Evaluation of the 13C-methacetin breath test for quantitative liver function testing.

Noninvasive 13C-breath tests are used for the assessment of hepatocellular dysfunction. 13C-methacetin is metabolized in the liver by O-demethylation to 13CO2 and acetaminophen. The aim of the study was to evaluate the 13C-methacetin breath test in comparison to the Child-Pugh score and other quantitative liver function tests (MEGX-test and indocyanin green-clearance). 2 mg/kg 13C-methacetin were orally given to 31 patients with histologically proven liver cirrhosis of different etiology and severity (nine Child A, 13 Child B, nine Child C), ten patients with chronic viral hepatitis and ten healthy volunteers. The increase of exhaled 13CO2 was expressed as delta over baseline (DOB; delta /1000). Different DOB-values were compared as parameters for assessing hepatocellular dysfunction. All breath test parameters analyzed provided an excellent discrimination between cirrhotic and noncirrhotic individuals. The DOB-value at 20 min showed a superior correlation with the Child-Pugh score (r = 0.67) than did MEGX-test or indocyanine green clearance results (r = 0.39 and r = 0.43, respectively). With a cut-off value of < or = 25 delta /1000 at 20 min, sensitivity and specificity to discriminate between cirrhotic and noncirrhotic individuals was 93.5% and 95%, respectively. The 13C-methacetin breath test is a safe and precise quantitative liver function test. Using one single breath sample 20 min after substrate administration, the test discriminates well between cirrhotic and noncirrhotic patients. Its prognostic value remains to be established.

Acetamides↗
PubMed2006

Accuracy of B-type natriuretic peptide tests to exclude congestive heart failure: systematic review of test accuracy studies.

BACKGROUND: Congestive heart failure (CHF) is a major public health problem. The use of B-type natriuretic peptide (BNP) tests shows promising diagnostic accuracy. Herein, we summarize the evidence on the accuracy of BNP tests in the diagnosis of CHF and compare the performance of rapid enzyme-linked immunosorbent assay (ELISA) and standard radioimmunosorbent assay (RIA) tests. METHODS: We searched electronic databases and the reference lists of included studies, and we contacted experts. Data were extracted on the study population, the type of test used, and methods. Receiver operating characteristic (ROC) plots and summary ROC curves were produced and negative likelihood ratios pooled. Random-effect meta-analysis and metaregression were used to combine data and explore sources of between-study heterogeneity. RESULTS: Nineteen studies describing 22 patient populations (9 ELISA and 13 RIA) and 9093 patients were included. The diagnosis of CHF was verified by echocardiography, radionuclide scan, or echocardiography combined with clinical criteria. The pooled negative likelihood ratio overall from random-effect meta-analysis was 0.18 (95% confidence interval [CI], 0.13-0.23). It was lower for the ELISA test (0.12; 95% CI, 0.09-0.16) than for the RIA test (0.23; 95% CI, 0.16-0.32). For a pretest probability of 20%, which is typical for patients with suspected CHF in primary care, a negative result of the ELISA test would produce a posttest probability of 2.9%; a negative RIA test, a posttest probability of 5.4%. CONCLUSIONS: The use of BNP tests to rule out CHF in primary care settings could reduce demand for echocardiography. The advantages of rapid ELISA tests need to be balanced against their higher cost.

Biomarkers↗
PubMed1997

A descriptive study of BRCA1 testing and reactions to disclosure of test results.

BACKGROUND: The identification of the BRCA1 gene is a powerful tool for predicting a patient's lifetime risk for carcinoma of the breast and ovary when she has hereditary breast/ovarian carcinoma (HBOC) syndrome. The process of BRCA1 testing and genetic counseling and participants' reactions to test results, are described. METHODS: Education about the natural history of HBOC syndrome and the pros and cons of genetic testing was provided to 14 HBOC families comprised of 2549 bloodline relatives. Of these, 388 underwent DNA testing. After informed consent was given by participants, formal linkage analysis and gene mutation studies were performed on the families. Qualitative data on intentions and emotional reactions were collected by physicians/counselors during the genetic counseling sessions. RESULTS: Of those tested, 181 received their results after further genetic counseling. Seventy-eight of them were positive and 100 were negative for BRCA1 gene mutation. Three had ambiguous findings. The most common reasons given for seeking DNA testing were concern about risk to children and concern about surveillance and prevention. Prophylactic mastectomy was considered by 35% of women who tested positive, whereas prophylactic oophorectomy was considered an important option by 76%. Twenty-five percent of both BRCA1 positive and negative individuals were concerned about discrimination by insurance companies. Eighty percent of those who tested negative reported emotional relief, whereas over one-third of those who tested positive reported sadness, anger, or guilt. CONCLUSIONS: DNA testing of patients with HBOC syndrome must be performed in the context of genetic counseling. The authors' results demonstrate the many complex clinical and nonclinical issues that are important in this process.

Adult↗
PubMed2000

Test characteristics of immunofluorescence and ELISA tests in 856 consecutive patients with possible ANCA-associated conditions.

OBJECTIVE: To examine the test characteristics of immunofluorescence (IF) and enzyme-linked immunosorbent assays (ELISA) in a consecutive series of patients under evaluation for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). METHODS: Using stored sera, we performed a cross-sectional study on 856 consecutive patients tested prospectively for ANCA by IF, Based on guidelines from the 1994 Chapel Hill Consensus Conference (CHCC), we determined each patient's underlying diagnosis by a medical records review without regard to their ANCA status (the CHCC guidelines do not require ANCA as a prerequisite for diagnosis). We grouped patients with forms of vasculitis commonly associated with ANCA into one of 4 types of AAV: Wegener's granulomatosis (n = 45), microscopic polyangiitis (n = 12), Churg-Strauss syndrome (n = 4), and pauci-immune glomerulonephritis (n = 8). We also classified patients without clinical evidence of AAV (92% of all patients tested) into 5 predefined categories of disease (including "other") and an additional category for no identifiable disease. In a blinded fashion, we then performed ELISAs on the stored serum for antibodies to proteinase-3 (PR3) and myeloperoxidase (MPO) and calculated the test characteristics for both ANCA assay techniques. RESULTS: Sixty-nine of the 856 patients (8.1%) had clinical diagnoses of AAV based on CHCC guidelines. The positive predictive value (PPV) of ELISA for AAV was superior to that of IF, 83% versus 45%. For patients with both positive IF tests and positive ELISA tests, the PPV increased to 88%. Both IF and ELISA had high negative predictive values (97% and 96%, respectively). Positive ELISA tests were associated with higher likelihood ratios (LR) than IF (54.2 [95% CI = 26.3, 111.5] versus 9.4 [95% CI = 6.9, 12.7]). The LR of both a positive IF and a positive ELISA was 82.1 (95% CI = 33.3, 202.5). CONCLUSIONS: Compared with IF, an ELISA test fo ANCA was associated with a substantially higher PPV and LR for AAV. This fact, combined with the greater sensitivity of IF, suggests that an effective testing strategy is to perform ELISA tests only on samples that are positive for ANCA by IF.

Antibodies, Antineutrophil Cytoplasmic↗
PubMed2006

The "Consecutive Combined Test"--using double test from week 8 + 0 and nuchal translucency scan, for first trimester screening for Down syndrome.

OBJECTIVE: To test the performance of the "Consecutive Combined Test", applied on a high-risk population. The classic "Combined Test" (Double test (DT) and Nuchal Translucency (NT) measurement on the same day at app. week 12) gives detection rates (DR) for Down syndrome (DS) of 80-90% for false positive rates (FPR) of 5%. In affected pregnancies, however, the low PAPP-A level is more pronounced, the earlier in pregnancy. Thus, we hypothesized that the Double Test could be taken as early as from week 8 + 0, without compromising the excellent performance of the Combined Test. This "Consecutive Combined Test" allows for a centralised laboratory function. METHODS: Inclusion criteria were maternal age > 35 years (80%) or a family history (20%). Double test was taken at a median gestational age (GA) = 10 weeks. NT was measured at GA = 11 + 0 - 13 + 6. A combined risk estimate of > 1:400 at birth was used as cut-off. RESULTS: 881 had the full test. Screen positive = 34. CVS with aneuploidy = 11 (6 trisomy-21, 5 others). FPR = 3.2%. Positive Predictive Value (PPV) = 17.6% for T-21. CONCLUSION: The "Consecutive Combined Test" applied on a high-risk population seems to be highly efficient with a remarkably high PPV.

Adult↗
PubMed1996

Determination of the intra- and interlaboratory reproducibility of the low volume eye test and its statistical relationship to the Draize eye test.

The reproducibility of toxicologic test methods, including alternative tests, is a key scientific and regulatory concern. In the present work, historic rabbit eye irritation data were used to determine the intra- and interlaboratory reproducibility of the low volume eye test (LVET). The standard Draize eye irritation test was used as the basis for comparison. The LVET and Draize tests had similar degrees of intra- and interlaboratory reproducibility as determined by examination of their coefficients of variation, although the variability in LVET results was directionally lower. Results from 70 parallel Draize and LVET tests indicated a strong positive association between results from the two tests, for corneal, iridial, conjunctival, and maximum average scores (MAS). Correlation coefficients were 0.60, 0.73, 0.69, and 0.73, respectively (P </= 0.0001). The linear relationship between LVET and Draize MAS values was examined by regression analysis and found to follow the relationship LVET MAS = 0.522 (Draize MAS). Thus, the LVET is at least as reproducible as the Draize test and gives responses that are (linearly) correlated to the Draize. The previous findings that the LVET is more predictive of human eye responses than the Draize test lends additional support for its use as a refined alternative to the Draize test.

Alcohols↗
PubMed1984

Validity of various function tests performed in Japan as a screening test for vibration syndrome.

In Japan, various function tests on the upper extremities are widely performed for the early diagnosis of vibration syndrome. The validity of these function tests was investigated by discriminant function analysis. The correct classification rate of the 120 workers exposed to vibration and the 40 control workers was 83.1%, when including the exposure-to-cold test. Therefore, the function tests were confirmed to be of diagnostic significance as a screening test for vibration syndrome. However, the rate is not sufficient to make a diagnosis only with the function tests. When not including the exposure-to-cold test, the rate was reduced by 10% because insidious functional disorders were missed in the early stage. For the early diagnosis of vibration syndrome, the exposure-to-cold test should be included in the function tests. Furthermore, to enhance the validity of the diagnosis, the results of the function tests should be evaluated together with subjective symptoms and the findings on bones and joints, the central nervous system and the endocrine system.

Adult↗
PubMed1998

[Diagnosis of anterior knee instability. Comparison between the Lachman test, the KT-1,000 arthrometer and the ultrasound Lachman test].

We reviewed 45 patients on average 14.7 years after surgery for rupture of the anterior cruciate ligament. The aim of the study was to compare the reliability of the Lachman test to evaluation of knee laxity with the KT 1000 arthrometer and the ultrasound-assisted Lachman test. Forty-five knees were examined with the Lachman test: 12 knees showed no sign of instability; 20 had a + positive Lachman test with a hard end point; 6 with a + positive test had no end point and were rated as unstable; a +2 Lachman test was found in 7 knees. With the KT 1000 Arthrometer 44 knees were examined: 30 knees were graded as stable according to the criteria of Daniel; 14 knees were unstable. We used the ultrasound-guided Lachman test in 44 knees. Taking only the side-to-side difference into account, 37 knees were stable and 7 unstable. According to Gruber, a single translation greater than 4 mm is also a sign of instability. Therefore, 12 knees were unstable, although 6 of these knees were rated as stable, taking the side-to-side difference into account. Comparing the two instrument measurements, all knees with ultrasound-rated instability on the basis of side-to-side measurements were also rated as unstable with the KT 1000 arthrometer. Only half of the knees rated as unstable because of a single translation greater than 4 mm with the ultrasound technique were rated as unstable with the KT 1000 arthrometer. Our results show that the accuracy of the Lachman test is as good as the instrument evaluation if the end point is taken into consideration. A positive Lachman test indicating anterior knee laxity is one where the soft end point is as described by Torg et al. Both instrument measurements are accurate in indicating anterior knee laxity, but only if they are used by an experienced examiner. Using the side-to-side measurements, the sensitivity of the KT 1000 arthrometer is higher. If only single translations greater than 4 mm without a significant side-to-side difference with the ultrasound technique are interpreted as anterior knee instability, then some knees will be rated as unstable, although both the clinical and KT 1000 arthrometer examinations prove them to be stable. We believe that only a side-to-side difference with the instrument techniques should be interpreted as knee laxity. Borderline positive measurements should only be used together with the clinical findings. Both instrument measurements can help to improve the quality of the clinical examination if the examiners are inexperienced. If instrument measurements are required, we believe that the ultrasound technique is easy and cheap to perform. Nevertheless, we believe that instrument measurements of anterior knee laxity are not necessary if a thorough clinical examination is performed, taking the end point of the Lachman test into consideration.

Anterior Cruciate Ligament↗
PubMed2005

A selective test for antidepressant treatments using rats bred for stress-induced reduction of motor activity in the swim test.

RATIONALE AND OBJECTIVE: This paper describes a new procedure for detecting effective antidepressant treatments. The procedure uses the swim-test susceptible (Susceptible) rat which has been selectively bred to show decreased struggling behavior in a swim test after exposure to a mild stressor. The ability of treatments to block this decrease in swim-test activity was assessed as a method for detecting effective antidepressants. RESULTS: In both male and female Susceptible rats, chronic (14-day) treatment with different antidepressant drugs delivered via osmotic minipump [i.e., three tricyclics (desmethylimipramine, imipramine, amitriptyline), two selective serotonin reuptake inhibitors (fluoxetine and sertraline), a monoamine oxidase inhibitor (phenelzine), and two atypical antidepressants (venlafaxine and bupropion)] all prevented the stress-induced decrease in swim-test struggling normally shown by these rats. Electroconvulsive shock had a similar effect. Unlike antidepressant drugs, 14-day treatment with various non-antidepressant drugs [i.e., a stimulant (amphetamine), an anxiolytic (chlordiazepoxide), an antihistamine (chlorpheniramine), and an anticholinergic (scopolamine)] did not have this effect. Antidepressant drug treatment for 1 day (i.e., acute treatment) was also ineffective in this test. The procedure described above requires use of the Susceptible rat--swim test resistant rats (i.e., rats selectively bred to be resistant to decreased swim-test activity after exposure to stressful conditions) showed no significant differences in swim-test behavior between stress and nonstress conditions after 14-day drug treatment, and randomly bred Sprague-Dawley rats did not show a decrease in swim-test activity following exposure to the mild stressor that is the basis for the test. CONCLUSION: These results suggest that the procedure described here, which uses a rat subject that has been bred for vulnerability to stressful conditions, may be a selective screening technique for effective antidepressant treatments.

Animals↗
PubMed2006

Analysis of the results of a proficiency test in screening mammography at the CSPO of Florence: review of 705 tests.

PURPOSE: The aim of this study was to evaluate the performance of a sample of Italian radiologists undergoing a proficiency test of screening mammography. MATERIALS AND METHODS: We retrospectively analysed the results of 705 tests (537 first tests, 168 repeat tests) taken during 1997-2005 by 537 Italian radiologists. The test, consisting of 17 screen-detected cancer cases and 133 negative controls, was validated by a panel of expert readers defining a minimum standard as to sensitivity for cancer and recall rate of negative controls. Success rates were assessed as a function of previous experience in mammography (years of experience, total mammograms read, mammograms read in the last year). RESULTS: A total of 176 radiologists successfully passed the test at their first attempt (32.7%). Success correlated with experience, measured in terms of years of experience (5-year cutoff: chi(2) for trend=4.17, p=0.04), total mammograms read (chi(2) for trend =11.8, p=0.002) or mammograms read in the last year (chi(2) for trend=6.27, p=0.04). Training improves performance at repeat testing: after a first negative attempt, a second attempt was successful in 50.6% of cases (74/146) and a third in 68.1% (15/22). CONCLUSIONS: A substantial proportion of Italian radiologists taking the test showed limited proficiency in screening mammography. This finding is consistent with several reports of poor performance of service screening compared with reference standards. As expected, test performance is associated with experience, suggesting that the current policy of employing non-dedicated, untrained, general radiologists in screening should be reconsidered. Test performance improves with training (courses, consultation of teaching atlases). Several screening programmes in Italy have been implemented without prior adequate radiologist training. Radiologist training needs to be considered a priority, at least in those screening programmes that are still to be implemented in one third of the country.

Aged↗
PubMed1983

The superiority of the metyrapone test versus the high-dose dexamethasone test in the differential diagnosis of Cushing's syndrome.

Differentiating the cause of Cushing's syndrome traditionally has depended upon measuring the response of 24-hour urine samples of cortisol or glucocorticoid metabolites to the high-dose (8 mg per day) dexamethasone test. The metyrapone test, however, is more convenient because it is a shorter test and requires the obtainment of serum samples, which can be collected more simply and more reliably than 24-hour urine samples. The usefulness of these two tests has not been adequately evaluated in a large series of patients with Cushing's syndrome. This study prospectively evaluated the accuracy of the dexamethasone and metyrapone tests in determining the cause of Cushing's syndrome in a series of 25 unselected patients. The diagnostic accuracy of these tests was calculated as follows: diagnostic accuracy = true positives and true negatives/study population X 100. Results of this study demonstrated that the metyrapone test was more accurate than the dexamethasone test in differentiating Cushing's disease from adrenocortical neoplasm (diagnostic accuracy, 100 percent versus 81 percent). All patients with Cushing's disease had a normal postmetyrapone 11-deoxycortisol concentration (greater than 10 micrograms/dl), while all patients with adrenocortical neoplasm had a suppressed 11-deoxycortisol concentration (less than 10 micrograms/dl). Thus, this study demonstrates that the metyrapone test is superior to the high-dose dexamethasone test in the differential diagnosis of Cushing's syndrome.

Adolescent↗
PubMed1980

Antepartum fetal heart rate testing. V. The nonstress test--an outpatient approach.

A total of 567 tests were performed in a 1 year period on 399 patients in an outpatient clinic setting to test the feasibility of an office approach to antepartum heart rate testing. Of these tests, 510 were reactive and 57 were nonreactive (NR); 15 NR tests had associated spontaneous CST's; 39 NR tests and one reactive test with an equivocal spontaneous CST were repeated in 2 to 4 hours; 30 tests were reactive and nine tests remained NR. An oxytocin-induced CST was needed to clarify fetal status in only nine of 607 tests. With this approach, the NST may be quite appropriate for office use.

Female↗
PubMed1987

Comparative diagnostic value of the calcium-pentagastrin test versus the tolbutamide test in a patient with a somatostatinoma.

We describe a patient with a small somatostatinoma of the papilla of Vater without clinical evidence for diabetes mellitus, diarrhea, steatorrhea, or cholelithiasis, showing normal plasma basal levels for somatostatinlike immunoreactivity. The diagnosis was based on histologic and immunohistochemical analysis of tumor tissue and hypersomatostatinemia induced by the calcium-pentagastrin test. Before removal of the tumor both diagnostic tests recommended for the detection of a somatostatinoma, a tolbutamide test and a calcium-pentagastrin test, were performed. Whereas the calcium-pentagastrin test provoked a markedly elevated plasma somatostatin level in association with a depressed plasma neurotensin level, the tolbutamide test surprisingly did not. After removal of the tumor the calcium-pentagastrin test no longer induced hypersomatostatinemia. Further studies are needed to determine whether the calcium-pentagastrin test is a more reliable diagnostic test than the tolbutamide test in somatostatinomas with normal plasma basal levels.

Adenoma, Islet Cell↗
PubMed1992

Micral-Test: a qualitative dipstick test for micro-albuminuria.

Micro-albuminuria is a very sensitive predictor of the development of renal disease in insulin- and non-insulin-dependent diabetes mellitus. A reliable dipstick test for routine screening for micro-albuminuria is, therefore, desirable. Such a test has been developed by Boehringer Mannheim, Germany, and marketed as Micral-Test. It is an immunological slide-test with semi-quantitative properties. To evaluate its performance as a screening test we compared it with a turbidimetric immuno-assay. In 396 urine specimens from 132 patients, sensitivity was 91% and specificity 96% for a discriminating albumin level of 20 mg/l. Correlation with quantitative values was reasonable (r = 0.73). We also tested for micro-albuminuria, defined as mean albumin excretion rate of > or = 20 micrograms/min, determined with the turbidimetric immuno-assay in timed overnight urines on three consecutive days, whereas Micral-Test was considered to be positive for micro-albuminuria if the albumin concentration in one of the three urine samples was > or = 20 mg/ml. In 132 patients, the sensitivity of Micral-Test was 82% and the specificity 86%. Albumin excretion rate in all false-negative results was < 50 micrograms/min. We therefore concluded that Micral-Test is a useful qualitative screening test for micro-albuminuria in diabetic patients.

Albuminuria↗
PubMed2005

Safety testing for neurovirulence of novel live, attenuated flavivirus vaccines: infant mice provide an accurate surrogate for the test in monkeys.

Current requirements for control of live viral vaccines, including yellow fever 17D, produced from potentially neurotropic wild-type viruses include tests for neurovirulence in nonhuman primates. We have used yellow fever 17D virus as a live vector for novel flavivirus vaccines (designated ChimeriVax) against dengue, Japanese encephalitis (JE), and West Nile (WN) viruses. For control of these vaccines, it would be preferable to substitute a test in mice for the test in a higher species (monkeys). In this study, we compare the neurovirulence of ChimeriVax vaccine candidates in suckling mice inoculated by the intracerebral (IC) route with graded doses of the test article or yellow fever 17D vaccine as a reference control. Mortality ratio and survival distribution are the outcome measures. The monkey safety test is performed as described for control of yellow fever vaccines. In both mice and monkeys, all chimeric vaccines were significantly less neurovirulent than yellow fever 17D vaccine. The test in suckling mice discriminated between strains of two different vaccines (ChimeriVax-JE and ChimeriVax-DEN1) differing by a single amino acid change, and was more sensitive for detecting virulence differences than the test in monkeys. The results indicate that the suckling mouse test is simple to perform, highly sensitive and, with appropriate validation, could complement or possibly even replace the neurovirulence component of the monkey safety test. The test in infant mice is particularly useful as a means of demonstrating biological consistency across seed virus and vaccine lots.

Animal Use Alternatives↗
PubMed2005

Development of rearing and testing protocols for a new freshwater sediment test species: the gastropod Valvata piscinalis.

This paper aimed at proposing rearing and testing protocols for Valvata piscinalis, a new potential species for sediment toxicity testing. Such tests were developed since this species reliably represents the bio/ecological characteristics of other gastropods. It may thus be representative of their sensitivity to chemicals. V. piscinalis was successfully cultured in our laboratory for six generations. Cultures provided a high productivity for a low working time and low costs. The tests conditions we proposed seemed to be relevant for the development of reliable tests with this species. Indeed, hatching probability of egg-capsules, as well as embryo, newborn and juvenile survival rates, were close to 100%. Moreover, growth rates and fecundity were significantly higher than in field and in other laboratory studies. Partial life-cycle tests on clean sediments were achieved for various feeding levels to determine survival, growth and reproduction patterns, ad libitum feeding level and life cycle parameters values. Ad libitum feeding levels for newborn, juveniles and adults were 0.1, 0.4 and 0.8 mg Tetramin/individual/working day. Growth tests with zinc-spiked sediments provided a no-effect concentration and a lowest effect concentration of respectively 200 and 624 mg zinc/kg dry sediment. Other growth tests on spiked sediments we ran at our laboratory with second, third and fourth instars larvae of Chironomus riparius pointed out that V. piscinalis was more sensible to zinc than the chironomid, which is a routine test species in ecotoxicology. According to these results, V. piscinalis is a promising candidate species for sediment toxicity testing.

Animals↗
PubMed2005

[Development of an olfactory screening test based on the Connecticut test (CCCRC)].

OBJECTIVE: To create a screening olfactory test based on the CCCRC (Connecticut Chemosen-sory Clinical Research Center). MATERIAL AND METHODS: We compare the screening test based on CCCRC with PST (Pocket Smell Test) based on UPSIT in 40 patients with nasal poliposis, in order to de-termine the specificity, sensitivity, positive predictive and negative predictive value. The validity index was 95% and accuracy rate was 10%. We determine unit cost, the time required to perform the test in outpatients office and how difficult it is to do the test. RESULTS: Sensibility was 88%, specificity was 77%. The positive predictive value was 34% and the negative predictive value was 94%. The unitary cost of our screening test was 0.57 euros when it is performed by a nurse. The unitary cost of PST is 1.76 euros. To perform our screening test took 2.8 +/- 0.4 minutes. The 96% of the patients thought the test was easy to do. CONCLUSION: Our test is a valid screening test to be used in patients with nasal poliposis.

Adolescent↗
PubMed1989

Nonstress testing with acoustic stimulation and amniotic fluid volume assessment: 5973 tests without unexpected fetal death.

In a 36-month period antepartum testing was performed 5973 times in 2628 women with singleton high-risk pregnancies. The testing scheme involved a modified nonstress test with sound stimulation. Testing was performed twice weekly for patients with diabetes (classes B through R), gestational age exceeding 42 weeks, and documented intrauterine growth retardation, and weekly for other indications. If no spontaneous acceleration was observed within 5 minutes, a single 1- to 2-second sound stimulus was applied to the lower maternal abdomen with an artificial larynx. If necessary, a second sound stimulation was applied within 10 minutes. In addition all patients received ultrasonographic four-quadrant assessment of amniotic fluid volume. The mean testing time was 10 minutes. Only 2% of tests were nonreactive with sound stimulation. Seventeen percent of nonstress tests that were nonreactive with sound stimulation were followed by positive results of a contraction stress test or a biophysical profile score less than or equal to 4. The overall intervention rate was 3%. All fetuses with a single acceleration only eventually met criteria for negative results to a contraction stress test or had a biophysical profile score greater than or equal to 8. There were no unexpected antepartum fetal deaths. Sound-induced accelerations appear to be valid in the prediction of fetal well being, and the use of sound stimulation results in a significant shortening of testing time. Simultaneous assessment of amniotic fluid volume may reduce the risk of fetal death to a negligible level.

Acoustic Stimulation↗