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PubMedDate not supplied

[A new method for self assessment of the pH value of vaginal secretions using an indicator-coated panty liner--initial preliminary report].

BACKGROUND: The measurement of the pH-value in the secretions of the vagina is one of the most important early diagnostic methods to recognize disturbances of the vaginal milieu in order to prevent the very early premature deliveries. Up to now, within the framework of a prenatal care program, the acidity of the vagina was assessed by the women themselves "invasively" by introduction of a special indicator device (pH-strips or disposable pH-measuring gloves). Now we have developed a possibility to assess the pH-value just by simple inspection of an indicator coated panty liner, which is worn for a couple of hours. The results can be assessed by comparing the color of the indicator with a standard scale. RESULTS: It was possible to assess the pH in 77% of 133 parallel measurements comparing the pH of the vagina and of the indicator coated panty liner in 19 pregnant women. An agreement of the two methods for pH-determination was found in 66%. CONCLUSIONS: These results are encouraging and further investigation in larger series of cases are in progress.

Acid-Base Equilibrium↗
PubMed1985

[Detection of hyperamylasuria. Value of a quick test].

A new reactive strip was used in a hospital admission unit, to detect amylasuria in the urine of 76 patients consulting for abdominal pain (population A) and of 68 unselected patients (population B). Detection on admission by this method was concordant with subsequent laboratory detection in 93% of the cases. The fast test was positive for amylasuria in 17 patients: 13 (17.1%) in population A and 4 (5.9%) in population B. The 8 patients recorded as "+" had moderate amylasuria with multiple but ill-defined symptoms mostly abdominal. The 9 patients recorded as "++" had marked amylasuria highly suggestive of an abdominal disease, including 4 cases of chronic pancreatitis.

Acute Disease↗
PubMed1992

Effect of time and storage conditions of Chemstrip bG on estimating blood glucose aboard ambulances.

This study tested the hypothesis that the age of Chemstrip bG aboard ambulances is not associated with decline of accuracy. This was accomplished by removing and testing Chemstrips bG from ambulances in Salt Lake City, Utah, U.S.A. Chemstrips were developed with three concentrations of glucose (2.0, 3.8, 12.4 mmol/L; 35, 68, 223 mg/dL, respectively) in a blinded manner by three different researchers and compared with fresh controls and with the Dimension Analyzer-derived glucose. Results showed that older Chemstrips read significantly higher than fresh strips at each value of glucose tested (p less than 0.05). Increased age was associated with higher readings. Therefore, it is possible that cases of hypoglycemia may be missed by reliance on older Chemstrips. While fresh strips tended to underestimate glucose at 12.4 mmol/L, age and storage aboard ambulances tended to reverse this underestimation; older Chemstrips were associated with a more accurate reading at 12.4 mmol/L. Older age was also associated with increased standard deviation of Chemstrips. Unless this bias is considered in clinical practice, it might result in a failure to detect and treat a patient with hypoglycemia. Chemstrips aboard ambulances should be interpreted with caution when evaluating a patient on the threshold of hypoglycemia. Meanwhile, institution of a quality control program is indicated. This would include periodic testing, but might also include storage of Chemstrips, when not in use, in a climate-controlled area either on or off the ambulance.

Ambulances↗
PubMed1983

The utility of overnight urine collections in assessing compliance with a low sodium intake diet.

To develop methods of estimating sodium intake in free-living persons, we gave normal volunteers mean sodium intakes of 65, 110, and 200 mEq/day. The intake was randomly varied about each mean by an SD of 12.5% daily. Twenty-four-hour and night urinary sodium excretion were measured. Night urinary sodium excretion was also estimated by means of inexpensive quantitative and qualitative chloride titrator strips. The latter required no timed urine collection. A total of three 24-hour urine collections were necessary to differentiate the regimens with 95% accuracy. Three night urinary sodium excretory estimates by the quantitative chloride titrator provided 79% accuracy in identifying the level of dietary sodium intake. By applying the qualitative chloride titrator every other day, the dietary regimens could be differentiated with 95% accuracy. These techniques were not only useful in estimating sodium intake, but also provided a simple means of documenting compliance to sodium restriction. Patients should have no difficulty in applying these methods themselves in a home setting.

Adult↗
PubMed1982

[Self-control of blood sugar (author's transl)].

Nine well-trained insulin-dependent diabetics checked their blood sugar using a test strip (Haemo-Glukotest 20-800) and three reflectometers (Reflomat, Dextrometer, Glucosemeter) in order to compare the accuracy of the three instruments with that of the test strip. 227 single checks were carried out, and the blood sugar was checked by means of the hexokinase method. The correlation of the four methods with the hexokinase method was comparable: Reflomat r = 0.95, Dextrometer r = 0.94, Haemo-Glukotest 20-800 r = 0.93, Glucosemeter r = 0.91. Classification of the results into various measuring ranges yielded a comparable accuracy of all four methods between 40 and 250 mg/dl; above 250 mg/dl, there was a considerable decrease in accuracy even of the reflectometers. Hence, the reflectometers do not offer any significant advantages over the visual Haemo-Glukotest 20-800 readings as far as self-control of blood sugar by the diabetic is concerned.

Adult↗
PubMed1986

Laboratory assessment of three new monitors of blood glucose: Accu-Chek II, Glucometer II, and Glucoscan 2000.

We describe a laboratory assessment of three new monitors of blood glucose concentrations: the Boehringer "Accu-Chek II" (B), the Ames "Glucometer II" (A), and the Lifescan "Glucoscan 2000" (L). Inherent imprecision (CV) of each monitor was less than 2%. Maximum difference between individual monitors of the same type was less than or equal to 0.5 mmol/L. The volume of blood applied to the test strips is not critical, but duration of blood incubation or color development should be precise. Two types of test strips retained sufficient color 48 h after development to allow checking of the original measurement, and would be suitable as quality-control "spot" checks. Correlation coefficients for results for whole-blood glucose vs those for serum glucose (measured with the Beckman ASTRA-8) were: 0.992 (B), 0.967 (A), and 0.988 (L). Bias plots of these data showed positive bias for A (0.45 mmol/L) and L (0.17 mmol/L) in relation to serum-glucose measurements, but a negative bias of 0.32 mmol/L for B. Calibration solutions are not interchangeable. Although these versions of the monitors are probably not analytically superior to earlier models, they are easier to use.

Blood Glucose↗
PubMed2005

Measurement strategy and instrumental performance of a computer screen photo-assisted technique for the evaluation of a multi-parameter colorimetric test strip.

A measuring strategy for the evaluation of a seven parameters colorimetric test using a computer screen photo-assisted technique (CSPT) is demonstrated. CSPT is a versatile approach aimed at point of care or home tests that uses regular computer sets and web cameras as the whole instrument. Issues such as the stability and the equivalency on different platforms of the determinations have been addressed in the present work. The method uses an embedded local reference simultaneously measured with the tests and solves the evaluation as a classification problem. The achieved performance tested along 580 classifications covering all the ranges of the assay, using synthetic samples, yielded 97.2% correct determinations compared with 89.7% for the case of colorimetric determinations. The errors were concentrated in only two parameters that show a significant correlation with a set of quality indices used to assess the performance of the classification.

Colorimetry↗
PubMed1978

Home-testing for recurrent bacteriuria, using nitrite strips.

Follow-up of children with recurrent urinary infections would be simplified by an accurate home-testing program for detection of infection. We provided nitrite test strips to the parents of 30 girls with recurrent urinary infection to determine if twice weekly home testing of first-voided urine could reliably detect infection. Infections were documented by dip slides or colony counts indicating more than 10(5) bacteria per milliliter of urine. Twenty-four families (80%) complied over a mean study period of 11 months, detecting 28 of 30 episodes of bacteriuria (93%). No false-positive tests occurred. Urinary nitrate, the substrate for nitrite production by bacteria, was universally present (greater than 100 microgram/ml) in 80 children. The nitrite test is useful for home follow-up observation of children at high risk of bacteriuria if applied repeatedly by motivated parents.

Adolescent↗
PubMed1987

Isoamylase measurements with monoclonal antibody test strips.

A test strip with fixed monoclonal antibodies binding human salivary amylase (5) was used for the measurement of pancreatic amylase in human sera. The amount of salivary isoamylase adsorbed by the test strip increased with the amount of enzyme in the test solution, reaching a maximum absorption capacity of 620 mU at a test quantity of 900 mU. At about 160 U/l of pancreatic isoamylase (in a mixture containing 214 U/l of total alpha-amylase, both enzymes with 4-nitrophenyl-alpha-D-maltoheptaoside at 25 degrees C) imprecision within-run (and day-to-day) was 2.8% (and 6.8%) at this level of clinical importance. The preliminary 95%-reference interval from 33 healthy adults was calculated to be 16.6-44.2 U/l. The method proved valuable for the interpretation of slightly elevated alpha-amylase levels (up to twice the upper reference limit) and unusual lipase/amylase ratios.

Adult↗
PubMed1980

Elevated meconium lactase activity. Its use as a screening test for cystic fibrosis.

Screening of newborn infants could provide information needed to evaluate the effects of early treatment on the course and prognosis of cystic fibrosis (CF). Two procedures of screening meconium for CF were compared: increased albumin levels, detected by a commercial test strip; and increased lactase activity, detected by glucose production after incubation of meconium with lactose. Specimens positive by the lactase test were retested for albumin. Low-birth-weight infants accounted for more than half the positive test results with both procedures. Sweat chloride measurements were carried out only on infants whose meconium specimens had albumin concentration greater than 12 mg/g (wet weight), measured by radial immunodiffusion. Twelve infants with CF were identified through screening, six while testing 44,816 specimens by lactase activity test. Three additional infants with CF were missed because meconium specimens were negative to both tests.

Albumins↗
PubMed1984

A simple screening test for acute pancreatitis.

A urinary test strip for amylase (Rapignost-Amylase) was compared with plasma amylase assay in samples of urine and plasma collected on the day of admission to hospital from 23 patients with acute pancreatitis and 38 patients with other causes of acute abdominal pain. Plasma amylase was greater than 1200 IU/l in 24 patients (23 with pancreatitis and 1 with a perforated duodenal ulcer) and all were Rapignost-Amylase positive. Twenty-nine of the remaining patients were Rapignost-Amylase negative, but there were eight "false positives' with plasma amylase levels of 86-474 IU/l. The Rapignost-Amylase test is of potential value to screen for clinically occult acute pancreatitis.

Acute Disease↗
PubMed1981

Evaluation of home glucose measuring devices.

A large number of glucose-monitoring systems suitable for home use are now available. The Glucochek, an early model (Mk I) and a later (Mk II), the Stan Clark RAHC, the Glucometer, and 20-800 BM glycemie strips were evaluated with regard to accuracy, precision, model variability and operator variability before a particular system was recommended for patient use. Whole blood glucose, on samples samples taken in the Diabetic Clinic of The Royal Melbourne Hospital, Melbourne, was measured with the system under test and in the Biochemistry Department. Accuracy was indicated by the mean of the differences between the two results, and precision by the standard deviation of these differences-the closer these results to zero, the better the system. The 20-800 BM Glycemia strips gave the best results in the hands of an experienced operator, but showed the greatest interoperator differences. These differences decreased when a machine-based system was employed. The Glucochek Mk I did not perform satisfactorily. All the systems tested showed a marked decrease in accuracy and precision when blood glucose levels were greater than 15.0 mmol/L. These results show that a machine is not a necessary part of a home glucose-monitoring system; that patients on home glucose-monitoring must be trained and their results checked against a reference method initially and, ideally, at regular intervals; that home glucose-monitoring in patients with marked hyperglycaemia unreliable.

Blood Glucose↗
PubMed1992

New-generation RIBA hepatitis C strip immunoblot assays.

Second-generation hepatitis C virus (HCV) ELISAs are currently in use in Europe and have been submitted for approval in the United States. These new assays contain additional antigens from the putative nucleocapsid and NS-3 regions of the HCV genome in addition to the c100-3 antigen present in first-generation ELISAs. A supplementary test, the second-generation RIBA HCV strip immunoblot assay (2-RIBA HCV SIA) has also been developed. The strip immunoblot assay uses four recombinant HCV antigens [5-1-1 (NS-4), c100-3 (NS-4), c33c (NS-3), and c22-3 (NS-3) (nucleocapsid)] slot blotted on nitrocellulose. Screening of random volunteer blood donors with the Ortho second-generation HCV ELISA (ORTHO HCV 2.0 ELISA) indicates that a substantial change in the repeat reactive donor population is observed with the new test. Two notable features of this change are: (1) A large number of samples reactive in the 2-RIBA HCV SIA for the second-generation antigens, c33c and c22-3, are detected by the ORTHO HCV 2.0 ELISA; (2) the percentage of ORTHO HCV 2.0 ELISA reactive specimens found indeterminate (reactive for only one HCV antigen) by the 2-RIBA HCV SIA is higher than in first-generation HCV ELISAs (approximately 25 vs. 5%). In addition, ORTHO HCV 2.0 ELISA repeat reactive, 2-RIBA HCV SIA indeterminate samples are dominated by reactivity to c22-3 instead of c100-3, which is the case for first-generation HCV ELISA repeat reactive samples. Resolution of 2-RIBA HCV SIA indeterminate samples as either containing anti-HCV antibodies or not, is important in both diagnostic and blood screening environments, especially where donor notification is required. Our approach to resolution of these troublesome samples evolved from initial work with HCV peptides. Early studies with an experimental strip immunoblot assay containing 5 peptides from the nucleocapsid, E2 (NS-1), NS-4, and NS-5 regions of the viral genome indicated that peptides from the nucleocapsid and NS-4 regions of the genome could provide additional evidence for the presence of anti-HCV antibodies with good specificity, but other peptides suffered from poor specificity. In addition, no immunoreactive peptide from the NS-3 (c33c) region of the virus is available, presumably because the major epitope(s) of this key second-generation antigen is a conformational determinant.(ABSTRACT TRUNCATED AT 400 WORDS)

Blood Transfusion↗
PubMed2006

[Are blood glucose analyzers safe? Experiences of the BfArM based on all notifications received until end of 2005].

Since implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices (IVD Directive), issues and field corrective actions on in vitro diagnostic medical devices (IVDMD) have to be reported to the national competent authorities. In Germany these are the BfArM and the Paul Ehrlich Institute; the latter is responsible for Annex II products used for immune hematology, tissue typing and infectiology testing. Between the beginning of 1999 and the end of 2005 BfArM received n=653 notifications on IVDMD. From these n=128 concerned analyzers and sensors (test strips) for self monitoring of blood glucose. A similar quantity of cases was reported by users and manufacturers (44.5%). In n=31 of these cases a product defect was not confirmed after the investigation of the products by the manufacturers. Product failures were confirmed in n=35 cases. The remaining cases were caused by user errors (n=29) or the data were inconclusive (n=33), predominantly because the products were not or only partly available for investigation by the manufacturers. In those cases where product failure had been verified n=24 affected the sensors (test strips) and n=11 the analyzers. Corrective actions were performed by the manufacturers in n=34 cases. From these n=27 were cases in which a product failure had been detected. However, in n=7 cases the investigations of the manufacturers were followed by preventive corrective actions because the manufacturers became aware of potential causes of future product failures. The obtained results and experiences since 1999 show that the governmental system for post-marketing surveillance of products for self testing of blood glucose is an established tool to ensure product safety. Regarding the proportion of notifications concerning these over the counter (OTC) products, it becomes obvious that they are a focus for action for the competent surveillance authorities.

Blood Glucose Self-Monitoring↗
PubMed1986

Bedside capillary glucose measurement by staff nurses in a general hospital.

The accuracy of capillary blood glucose monitoring has been well demonstrated when applied by patients in the outpatient setting or by specially trained nurses on inpatient diabetes units. In order to determine the applicability of this technique in the more general hospital setting, a program was initiated for instructing general staff nurses in the use of Chemstrips bG strips and the Accu-Chek bG meter. As a pilot study, nurses on four general medical and surgical hospital floors performed capillary glucose determinations within 15 minutes of the drawing of venous blood samples for determination of plasma glucose in the hospital's Chemistry Laboratory. Two hundred ten paired measurements were made by 31 nurses. Linear regression analysis yielded a Pearson correlation coefficient of 0.96 between bedside and laboratory glucose measurements. The mean percent deviation between the two values was 7.9 percent. Acceptance by both nurses and patients was high. Properly supervised capillary glucose monitoring can provide a valuable adjunct to the care of hospitalized patients with diabetes.

Blood Glucose↗
PubMed2003

Schirmer tear test results in normal horses and ponies: effect of age, season, environment, sex, time of day and placement of strips.

Tear production was evaluated in 39 horses and 29 ponies using Schirmer tear test strips to determine whether diurnal or weekly fluctuations occur, whether location of strip placement has an effect, if values are the same for both eyes in an animal and whether sex, age, stabling vs. pasture and winter vs. summer had an effect. There was no test in which the raw score was less than 10 mm, although there were many occasions where tear wetting exceeded 35 mm. Analysis of the raw (continuous) scores by linear regression provided no evidence that signalment, housing or season or location of strip placement affected results. The distribution of tear test scores for a 'population' of eyes did not differ when the right eye was compared with the left eye or when the same eye was compared at different times on the same day. Individual test wetting values for opposing eyes measured at the same time, and also wetting values for the same eye measured at different times on the same day sometimes differed substantially. In winter maximum tear wetting exceeded 35 mm more frequently in the STT I than in the STT II even in housed horses and ponies, but there was no consistent significant difference. There appears to be wide variability in the STT I in normal horses and ponies.

Animals↗
PubMed2002

European Concerted Action on Anticoagulation. Evaluation of a method for International Sensitivity Index calibration of two point-of-care prothrombin time (PT) monitoring systems (CoaguChek Mini and TAS PT-NC) with fresh plasmas based on whole-blood equivalent PT.

BACKGROUND: The International Sensitivity Index (ISI) calibration of whole-blood prothrombin time (PT) monitors for point-of-care testing (POCT) described by Tripodi et al. (Thromb Haemost 1993;70:921-4) has been shown to be dependable but is too complex and demanding. The use of plasma would simplify calibration of whole-blood POCT PT monitors, but important differences may exist between the ISI for whole blood and plasma calibrations. METHODS: In a 10-center calibration study of two POCT whole-blood monitoring systems (CoaguChek Mini and TAS PT-NC), we characterized the relationship between the log PT for whole blood and fresh plasma with use of single lots of test strips/cards. This relationship (linear) was used to correct the difference between the whole-blood and plasma ISI. The reliability of the correction with different lots of test strips/cards was assessed at three centers. The linear relationship was used to correct the difference in the whole-blood and plasma ISI with four other lots of TAS PT-NC cards and with two additional lots of CoaguChek Mini test strips. RESULTS: The correction decreased the ISI difference from 13.3% to 0.9% for the TAS PT-NC and from 5.7% to 0.6% for the CoaguChek Mini. In assessments at three centers, which included different lots of test strips/cards, the mean ISI difference was markedly decreased with the TAS PT-NC but not with the CoaguChek Mini, for which the mean ISI difference increased slightly. CONCLUSIONS: The proposed correction resolves the discrepancy between whole-blood and fresh plasma ISI calibrations with TAS PT-NC test cards. The CoaguChek Mini systems could be calibrated without this correction.

Animals↗
PubMed1977

[Experiences with the API 20A system in routine species identification of anaerobes (author's transl)].

The API 20A System was tested in three modifications: a) The microtubes were inoculated with the API anaerobe basal medium, filled up completely with sterile mineral oil and incubated aerobically. b) The test strips were inoculated with the basal medium and incubated in an anaerobic chamber. c) The strips were inoculated with a modified Viande-Levure medium containing Tween 80, vitamin K3 and hemin. The microtubes were covered with sterile mineral oil and incubated in an anaerobic chamber. Each procedure was compared with the conventional method (PRAS) of the Virginia Polytechnic Institute. The overall agreement between the three modifications of the API System and the conventional method was 83.2, 91.7, and 98.5% related to the number of tests performed. The advantage of the modified medium was also demonstrated by measuring the growth rate of some anaerobes in thioglycolate broth, API basal medium and VL-medium, modified as mentioned above, nephelometrically. So the micromethod is more accurate and reliable when inoculated with an improved medium.

Anaerobiosis↗