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Imported platelets demonstrate decreased pH and glucose by reagent strip testing when compared to locally derived platelets.

The most common infectious risk from blood transfusion in the United States is bacterial contamination of platelet components. Although detection of bacterially contaminated platelet components is best achieved with a culture system, AABB standards permit alternatives including the use of staining methods or reagent strips. In this study, 13,216 consecutive platelet components were screened using reagent strips for evidence of the presence of bacteria. Testing was performed immediately prior to release of the platelet components for transfusion; 10,836 were collected locally and 2,380 were imported from other blood banks. A mix of whole-blood-derived and apheresis products was included. If either the glucose concentration was <250 mg/ml or the pH was <7.0, the platelet component was quarantined and a specimen was obtained for Gram's stain and culture. Every transfused platelet component that was associated with a reported transfusion reaction was also tested by Gram's stain and culture. Overall, 1.47% of imported platelet components were reactive while only 0.12% of locally collected platelets were reactive. Of 48 reactive platelet components, 44 were tested by Gram's stain and culture. None was found to be bacterially contaminated. In summary, imported platelet components were significantly more likely to be falsely reactive by reagent strip screening as compared to locally prepared platelet components.

Bacteria↗

Evaluation of the centrifuged and Gram-stained smear, urinalysis, and reagent strip testing to detect asymptomatic bacteriuria in obstetric patients.

OBJECTIVE: Our purpose was to compare the efficacy of the centrifuged and Gram-stained smear with the efficacy of both urinalysis and reagent strip testing for nitrites and leukocyte esterase in detecting asymptomatic bacteriuria in obstetric patients. STUDY DESIGN: A midstream urine specimen was evaluated in 528 patients either at the initial prenatal visit or at a visit because of possible preterm labor. Separate aliquots were tested by centrifugation (with a Cytospin Cytocentrifuge; Shandon, Inc, Pittsburgh, Pa) with Gram stain, by microscopic urinalysis for the presence of moderate to large numbers of bacteria or >10 leukocytes per high-power field, and by reagent strips for the presence of nitrites or leukocyte esterase activity. Results were compared with those of a quantitative urine culture obtained with blood and MacConkey agar plates. RESULTS: Thirty-six women (6.8%) had urine cultures showing 100,000 colony-forming units of a uropathogen per milliliter. The sensitivity and specificity of testing by centrifugation and Gram stain were 100% and 7.7%, respectively. Urinalysis and dipstick testing offered a sensitivity of 80.6% and 47.2%, respectively, with a specificity of 71.5% and 80.3%. No combination of tests, in series or in parallel, offered improved specificity over urinalysis alone. CONCLUSIONS: Centrifugation with Gram stain of a urine specimen offers excellent sensitivity but very poor specificity compared with microscopic urinalysis for the detection of asymptomatic bacteriuria and is not an acceptable screening test in an obstetric population. The false-negative rates of urinalysis (19.4%) and reagent strip testing (52.8%) preclude these from being excellent screening tests for asymptomatic bacteriuria. Given the potential sequelae of undiagnosed asymptomatic bacteriuria in an obstetric population, we conclude that urine cultures should be used for all pregnant patients to detect asymptomatic bacteriuria.

Adolescent↗

Accuracy of reagent strip testing for urinary tract infection in the elderly.

The accuracy of reagent strip testing for urinary tract infection (UTI) was assessed in 100 elderly patients (50 acute patients admitted to hospital and 50 attending the day hospital). Reagent strip sensitivities were: acute patients-urinary nitrite 83%, blood 67%, protein 72% and leucocytes 72%, and day hospital patients-urinary nitrite 90%, blood 65%, protein 30% and leucocytes 60%. Urinary nitrite specificities were 100% for both groups of patients. Only 28% of patients with a UTI had specific symptoms of the infection; pyrexia and a raised WBC also proved poor indicators. Urinary nitrite was thus the most accurate immediate indicator of UTI.

Aged↗

Diagnosis of spontaneous bacterial peritonitis in cirrhotic patients by use of two reagent strips.

OBJECTIVE: Spontaneous bacterial peritonitis (SBP) is one of the potentially life-threatening complications in ascitic cirrhotic patients with a mortality rate ranging between 30 and 50%. The improved survival might be explained by a more rapid diagnosis and treatment. The aim of our study was to assess the utility of two reagent strips, the Multistix test and the Combur(2) test LN, for the rapid diagnosis of SBP. METHODS: Thirty-one unselected consecutive cirrhotic patients with ascites were included and a total of 100 paracenteses were performed. All ascitic fluid was analysed with the two reagent strips, leucocyte and polymorphonuclear (PMN) leucocyte cell count and blood-bottle culture if the strips were positive. The strips were considered positive if the colour turned to purple: i.e. grade 3 or 4 for the Multistix test and 2 or 3 for the Combur(2) test LN on a colorimetric scale. RESULTS: We diagnosed nine infections of which four were SBP defined by PMN > or = 250 cells/mm(3) and a positive culture in ascitic fluid and five were culture negative neutrocytic ascites (PMN > or = 250 cells/mm(3) and a negative culture). The results of the two strips were concordant and were negative in only one SBP. The sensitivity, specificity, positive and negative predictive values of these two strips were 89%, 100%, 100% and 99%, respectively. CONCLUSIONS: These reagent strips are very sensitive and specific for the diagnosis of SBP, allowing immediate commencement of empirical antibiotic therapy. These strips should be used for the diagnosis of SBP, especially on an emergency basis.

Aged↗

Comparison of urine specific gravity values from total-solids refractometry and reagent strip method.

The comparison of specific gravity values of 561 urine samples from TS meter and reagent strip was made. The data were divided into two groups: group 1-less than 2+ protein contained urine samples and group 2--equal or more than 2+ protein contained urine samples. The results revealed that the specific gravity values from both methods in both groups were statistically different (p less than 0.01) but they were correlated at r = 0.84 (p less than 0.001) and r = 0.73 (p less than 0.001) in group 1 and group 2, respectively. It was concluded that the reagent strip is suitable for use as a screening test but it should not be considered when precise measurement is necessary.

Humans↗

An assessment of Stat Tek: a reagent-strip method for glucose determination.

Stat Tek, a reagent--strip method for glucose determination, has been evaluated. Aqueous solution of glucose standard is not recommended. The linearity of serum glucose is between 630 to 3,450 mg/l. The within run precision is between 0.7% to 3.0%. The day-to-day precision is between 2.8% to 5.6%. The recovery of glucose added to serum is between 95 to 101%. The correlation of glucose by Stat-Tek and SMA 6/60 show small proportional and constant errors. Stat-Tek is simple and easy to use; however, proper quality control and training of the user are essential for the correct measurement of glucose.

Blood Glucose↗

Urinalysis reagent strips in the screening of children for urinary schistosomiasis in the RSA.

The use of urinalysis reagent strips (Labstix; Ames) in screening for Schistosoma haematobium infection in various schistosomiasis-endemic areas of the RSA was assessed in 941 children. Sensitivity, specificity, false-positive and false-negative rates and the positive predictive value for haematuria and proteinuria were calculated. Both haematuria and proteinuria were positively correlated with the presence of S. haematobium eggs in the urine. Intensity of infection correlated positively with the degree of haematuria and proteinuria (P less than 0.001). The presence and intensity of S. haematobium infection were more closely related to the presence and degree of haematuria than to proteinuria. Screening for haematuria alone enabled 83.1% of S. haematobium-positive and 89.7% of negative subjects to be detected accurately. The false-positive rate was 2.7%. It was found that a single parameter, haematuria, could be used to identify infected children in endemic areas. It was also found to be possible to use the reagent strips to select out S. haematobium-infected children with egg counts greater than 200 ova/10 ml urine. The simple model developed allows rapid identification of moderately to heavily infected children and can be used by paramedical staff in field situations.

Adolescent↗

Evaluation of urinalysis reagent strips versus microscopical examination of urine for Schistosoma haematobium.

This study deals with the effectivecess of chemical reagent strips for detection of haematuria and proteinuria in selecting S. haematobium egg positive subjects as compared to microscopical examination of urine. Out of 222 students from primary and secondary rural schools, 191 were S. haematobium and 59 were parasitologically negative. 135 students had a count of less than 50 eggs/10 ml. urine and 56 had more than 50 eggs/10ml. The sensitivity of reagent strips in detecting haematuria was 10% and 36% for the groups with less than and more than 50 eggs/10 ml. of urine respectively. The correspondant microscope figures were 42% and 93% respectively. Proteinuria was detected in 11% and 29% of urines from the groups with less than and more than 50 eggs/10 ml. respectively. The specificity of strips and microscopical examination in detection of haematuria was 100%, while that for proteinuria was 97% as detected by strips. These results show that urinalysis strips cannot be used as an alternative to microscopic examination of urine for the presence of S. haematobium eggs.

Adolescent↗

Reagent strip diagnosis of UTI in a high-risk population.

A study was undertaken to determine the accuracy of reagent strip diagnosis of urinary tract infection (UTI) in patients seen in the ED who were subsequently admitted to hospital with this diagnosis. The reagent strip results of 100 patients were recorded and the sensitivity and specificity of various parameters in the diagnosis of UTI were calculated. Our results indicate that even in a group of patients with high clinical probability of UTI and with symptoms severe enough to be hospitalized, reliance on positivity of any single parameter alone gives unacceptably low sensitivity: 89%, 39%, 68%, and 63% for WBC, nitrite, RBC, and protein, respectively. We conclude that dipstick analysis is not sufficiently sensitive for diagnosis of UTI in high risk patients in whom missed diagnosis would have serious consequences.

Adult↗

The effect of the haematocrit value on the determination of glucose levels by reagent-strip methods.

Twenty-one patients' blood samples, each with modified haematocrit concentrations of about 20%, 30%, 40%, 50% and 60%, were assayed for the presence of glucose by two reagent-strip methods--the Ames Glucometer with BG reagent strips and the Reflolux reflectance meter with BM-test strips. The reference method was the YSI blood glucose analyser. Both Ames and BM systems were found to have good precision. Ames results were falsely high (mean, 15%) at a haematocrit value of 20% and falsely low (mean, 21%) at a haematocrit value of 60%. BM results also overestimated (mean, 4%) and underestimated (mean, 5%) at the corresponding haematocrit levels. The results showed good agreement between Ames and BM methods and the YSI method for normal haematocrit concentrations of 40% to 50%. Clinicians should be aware of inaccuracies in glucose results by test-strip methods in patients with abnormal haematocrit concentrations.

Blood Glucose↗

Determination of theophylline in serum with the Seralyzer Aris reagent strip test evaluated.

We evaluated a new Seralyzer Aris reagent strip test (Ames Div., Miles Labs.) for the determination of theophylline in human serum. The method is based on the monoclonal enzyme immunoassay with dry reagent chemistry. The analysis is rapid and simple to perform: results are available only 5-10 min after receipt of the sample. Intra-assay precision (CV) was 2.2-3.3% (n = 15) for theophylline concentrations of 5-25 mg/L; interassay CV was 5.9% (n = 19) at 15 mg/L. The results (y) agreed well with those by liquid chromatography (x): r = 0.949 (p less than 0.001), and y = 0.967x + 0.214. We conclude the method is useful for rapid evaluation of theophylline concentrations in asthmatic patients.

Antibodies, Monoclonal↗

Comparison between reagent strips used for detection of urinary tract infection in the elderly.

A comparison was made between the accuracy of Ames and Boehringer reagent strips for detecting urinary tract infections in 100 elderly patients (50 acutely ill patients admitted to hospital and 50 attending the day hospital). The results for urinary nitrite, blood and protein for both strips were documented. Nitrite provided the highest sensitivities and specificities. In the acute hospital patients, the sensitivities were 83% for the Ames and Boehringer strips respectively, while for the day hospital patients the sensitivities were 90% for both strips. Specificities were 100% for both strips in each group of patients. There was thus little difference between the accuracy of the Ames and Boehringer reagent strips in detecting urinary tract infection.

Aged↗

A clinical comparison of the performance of four blood glucose reagent strips.

The widespread use of visually read blood glucose reagent strips for initiation of emergent treatment of hypoglycemia and hyperglycemia has produced concern over the accuracy of this method. This study evaluated the accuracy of Chemstrip bG (Bio-Dynamics, Boehringer Mannheim, Indianapolis, IN), Dextrostix (Ames, Miles Laboratories, Elkhart, IN), Glucostix (Ames), and Visidex II (Ames) as compared with hospital laboratory values in an emergency department (ED) setting. Blood samples from 96 ED patients were tested for glucose concentration by each of the four strips and by the hospital laboratory. Each strip was evaluated for sensitivity, specificity, correlation coefficient (r), 95% confidence intervals, and kappa statistic (kappa, a measure of agreement between nonparametric data) using laboratory values as reference. In addition, six observers scored each strip for ease of interpretation using an ordinal scale of 1 (poor) to 4 (excellent). From the samples, no patients were hypoglycemic (less than or equal to 60 mg/dL), 83 were euglycemic (greater than 60 and less than 160 mg/dL), and 13 were hyperglycemic (greater than or equal to 160 mg/dL). Results suggest that over the range of glucose concentration sampled, there is good to excellent correlation with laboratory values for all strips except Dextrostix. The lower r value for Dextrostix is in part artifact due to limitation of its range of measurement to less than or equal to 250 mg/dL. Decreased accuracy for all strips in the hyperglycemic range may have been attributable to small sample size. Chemstrip bG and Visidex II were found to be subjectively easier to interpret.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Glucose↗

Dry-reagent strips used for determination of theophylline in serum.

A reagent strip for quantifying theophylline in serum or plasma has been developed for use with the Apoenzyme Reactivation Immunoassay System (ARIS) with the Ames Seralyzer reflectance photometer. The test takes 80 s and involves comparison with a two-point calibration line, which can validly be stored in the instrument for two weeks. Results for theophylline in clinical serum samples correlate well (r greater than 0.98) with results by liquid chromatography, fluoroimmunoassay, and enzyme immunoassay procedures. The within-run CV for four concentrations of controls ranged from 3.5 to 6%; the between-run CVs ranged from 3 to 5%. This assay for use in therapeutic drug monitoring is convenient, rapid, and simple, and thus is appropriate for use in emergency rooms, physician's offices, and small laboratories.

Chromatography, Liquid↗

A comparative study of a monoclonal immunoassay reagent strip test and high pressure liquid chromatography for theophylline.

Our experience with the determination of theophylline in serum using a monoclonal immunoassay reagent strip test is reported. The day-to-day precision of a series of drug assay controls (n = 74) was investigated with a mean theophylline value of 15,3 +/- 1,2 mg/l. Interference and/or cross reactivity of structurally related compounds and metabolites of theophylline was tested. Serum samples from 148 asthmatic patients who were treated with theophylline were analyzed by the SERALYZER ARIS*) reagent strip test and by high pressure liquid chromatography. A correlation coefficient of 0.99 was found between these techniques using a linear regression analysis.

Antibodies, Monoclonal↗

Correlation of leukocyte esterase detection by reagent strips and the presence of neutrophils: a study in BAL fluid.

STUDY OBJECTIVE: In the present study, we evaluated the leukocyte esterase (LE) area of a reagent strip designed for urinalysis for the semiquantitative measurement of the percentage of polymorphonuclear neutrophils (PMNs) in BAL fluid. DESIGN: Prospective. The relative PMN counts (obtained by conventional microscopy and expressed as a percentage of a 500 cell count) of consecutive BAL fluid samples were compared with the corresponding LE categories as read with a urine chemistry reader. LE categories were graded as follows: negative, trace, +, + +, and + + +. RESULTS: A total of 153 BAL fluid samples were included. The mean PMN counts of the negative LE category (4.1 +/- 4.3%; n = 43) and the + + + category (81.8 +/- 16.3%; n = 37) differed significantly from each other and from the mean PMN counts of the other categories. Within the trace, +, and + + categories, a considerable overlap of PMN counts was noted. Assignment of a BAL fluid to the negative LE category consistently predicted a PMN count < 20%. At a threshold value of 50% PMNs, the + + + LE category predicted the BAL fluid samples to the correct group (PMNs > 50% vs < 50%) with a sensitivity of 70.8% and a specificity of 97.1%. CONCLUSIONS: The reagent strips proved to be useful as a rapid test for semiquantitative measurement of the relative PMN counts in BAL fluid. However, the low predictive value for the exclusion of a high PMN count may limit their application.

Alveolitis, Extrinsic Allergic↗

Evaluation of two reagent strips and three reflectance meters for rapid determination of blood glucose concentrations.

We evaluated three reflectance meters (Accu-Chek II, Glucometer II, and Glucoscan 2000) and two reagent strips (Chemstrip bG and Glucostix) for accuracy and precision in determining blood glucose concentrations in the dog. To evaluate accuracy, we compared results of blood glucose determinations performed on 95 samples using the various strips and meters vs. the glucose concentrations obtained using the glucose-oxidase method on a Beckman Glucose Analyzer. Accuracy was evaluated statistically using least squares regression analysis. To evaluate precision, samples in various ranges of blood glucose concentration were tested repeatedly (20 times within a 1-hour period) on the same reflectance meter. Coefficient of variation (CV) was determined to evaluate reproducibility of results. Overall, there were significant correlations (P less than 0.001) between the laboratory glucose values and the blood glucose concentrations obtained with Chemstrip bG (r = 0.976), Glucostix (r = 0.904), Accu-Chek II (r = 0.986), Glucometer II (r = 0.911) and Glucoscan 2000 (r = 0.944). In the precision study, all three meters had excellent CVs in the normal range (3.6% to 4.9%). However, Accu-Chek II was found to be more precise in the hypoglycemic and hyperglycemic ranges (3.6% and 2.6%, respectively) than either Glucometer II (8.8% and 5.4%) or Glucoscan 2000 (7.8% and 8.2%). The results of this study indicate that all of the meters and reagent strips tested are highly accurate in determining blood glucose concentrations in the dog. However, both in terms of accuracy and reproducibility of results, Accu-Chek II and Chemstrip bG, gave the highest correlation coefficients and, as such, are probably of the greatest clinical value.

Animals↗

Evaluation of reagent strips in detecting asymptomatic bacteriuria in early pregnancy: prospective case series.

OBJECTIVE: To evaluate the performance of reagent test strips in screening pregnant women for asymptomatic bacteriuria at their first visit to an antenatal clinic. DESIGN: Prospective case series. SETTING: Antenatal clinic of a large inner city maternity hospital. SUBJECTS: All women attending for their first antenatal clinic. Patients taking antibiotics for any reason and those with urinary tract symptoms were excluded. INTERVENTION: A midstream urine specimen was divided; half was sent for microscopy and formal bacteriological culture and the other half was tested with a commercial reagent strip test for the presence of blood, protein, nitrite, and leucocyte esterase. MAIN OUTCOME MEASURES: Sensitivity, specificity, and positive and negative predictive values of the reagent strips in diagnosing asymptomatic bacteriuria (defined as 10(5) colony forming units/ml urine). RESULTS: Sensitivity was low, with a maximum of 33% when all four tests were used in combination. Specificity was high, with typical values of 99% or more. Positive predictive value reached a maximum of 69% and negative predictive value was typically 95% or more. CONCLUSION: Urine reagent strips are not sufficiently sensitive to be of use in the screening for asymptomatic bacteriuria and therefore many patients would be missed. In view of the potentially serious sequelae of this condition in pregnant women we recommend that formal bacteriological investigation remain the investigation of choice in this group of patients.

Bacteriuria↗