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The exact test result depends on the integrity of the urine test paper. Regardless of the brand, improper handling of the strips can lead to erroneous results, which can lead to possible misdiagnosis. An improperly tightened or recapped peel bottle exposes the contents to the humid environment in the indoor air, which may affect the integrity of the peel, cause degradation of the reagent, and ultimately lead to erroneous results.
Crolla et al.1 conducted a study in which the test strips were exposed to indoor air, and the instruments and reagent strips of three manufacturers were compared. The strip container should be sealed according to the manufacturer’s recommendations after use, otherwise it will cause indoor air exposure. This article reports the results of the study, comparing the MULTISTIX® 10SG urine test strip and Siemens CLINITEK Status®+ analyzer with products from two other manufacturers.
Siemens MULTISTIX® series urine reagent strips (Figure 1) have a new identification (ID) band. When combined with the CLINITEK Status range⒜ urine chemistry analyzer shown in the figure, a series of automatic quality checks (Auto- Checks) 2.
Figure 2. CLINITEK Status series analyzers use an algorithm to detect moisture-damaged reagent strips to help ensure quality results.
Krolla et al. The study evaluated the results produced by the combination of test strips and analyzers from three manufacturers:
For each manufacturer, two sets of reagent strips are prepared. The first group of bottles was opened and exposed to indoor air (22oC to 26oC) and indoor humidity (26% to 56%) for more than 40 days. This is done to simulate the exposure that the reagent strip may be exposed to when the operator does not properly close the reagent strip container (pressure strip). In the second group, the bottle was kept sealed until the urine sample was tested (no pressure bar).
Approximately 200 patient urine samples were tested in all three brand combinations. Errors or insufficient volume during the test will cause the sample to be slightly different. The total number of samples tested by the manufacturer is detailed in Table 1. Reagent strip tests were performed on the following given analytes using patient samples:
The urine sample test is completed within three months. For each set of strips, stressed and unstressed, test samples are repeated on all instrument systems. For each combination of strip and analyzer, run these replicate samples continuously.
The outpatient treatment center located in the urban area is the research environment. Most tests are performed by medical assistants and nursing staff, and intermittent tests are performed by trained (ASCP) laboratory personnel.
This combination of operators replicates the precise test conditions in the treatment center. Before collecting data, all operators were trained and their capabilities were evaluated on all three analyzers.
In the study conducted by Crolla et al., the consistency of the analyte performance between the unstressed and stressed reagent strips was evaluated by checking the first repeat of each test set, and then the consistency was compared with the unstressed (control) Compare the consistency between the results obtained)-Copy 1 and Copy 2.
The MULTISTIX 10 SG test strip read by CLINITEK Status+ Analyzer is designed to return an error flag instead of the actual result as soon as the system detects that the test strip is potentially affected by excessive exposure to environmental humidity.
When testing on CLINITEK Status+ Analyzer, more than 95% (95% confidence interval: 95.9% to 99.7%) of the stressed MULTISTIX 10 SG test strips return an error flag, which accurately indicates that the test strips have been affected and are therefore not suitable for use (Table 1) .
Table 1. Error marking results of uncompressed and compressed (humidity damaged) test strips, classified by manufacturer
The percentage agreement between two replicates of stress-free reagent strips from all three manufacturers’ materials (accurate and ±1 set) is the performance of the stress-free strips (control conditions). The authors used a scale of ±1 because this is the usual acceptable variance for urine test paper.
Table 2 and Table 3 show the summary results. Using precision or ±1 scale, there is no significant difference in the repeat consistency between the three manufacturers’ reagent strips under no stress conditions (p>0.05).
According to the repetition consistency rate of the stress-free strips of other manufacturers, it was observed that for the two repetitions of the stress-free reagent strips, there are only two distinct examples of percent consistency. These examples are highlighted.
For the Roche and diagnostic test groups, determine the percentage agreement between the first repetition of the stressed bar and the first repetition of the unstressed bar to evaluate the performance of the environmental stress test strip.
Tables 4 and 5 summarize the results for each analyte. The percentage of agreement for these analytes under stress conditions is very different from the percentage of agreement for control conditions, and is marked as “significant” in these tables (p<0.05).
Since nitrate tests return binary (negative/positive) results, they are considered candidates for analysis using ±1 set of criteria. Regarding nitrate, compared with the consistency of 96.5% to 98%, the stress test strips of Diagnostic Test Group and Roche have only 11.3% to 14.1 between the nitrate results obtained for repetition 1 under stress-free conditions and repetition 1 under stress conditions. The agreement of% was observed between repetitions of the unstressed condition (control).
For digital or non-binary analyte responses, the ketone, glucose, urobilinogen, and white blood cell tests performed on the Roche and diagnostic test strips had the highest percentage of difference in the output of the precise block between the pressure and the unstressed test strips.
When the consistency standard was extended to ±1 group, in addition to protein (91.5% consistency) and white blood cells (79.2% consistency), the divergence of Roche test strips was significantly reduced, and the two consistency rates and no pressure (Contrast) There are very different agreements.
In the case of test strips in the diagnostic test group, the percentage consistency of urobilinogen (11.3%), white blood cells (27.7%), and glucose (57.5%) continued to decrease significantly compared to their respective stress-free conditions.
Based on the data obtained with the Roche and Diagnostic Test Group reagent strip and analyzer combination, a significant difference between uncompressed and compressed results was observed due to exposure to humidity and room air. Therefore, based on erroneous results from the exposed strips, inaccurate diagnosis and treatment may occur.
The automatic warning mechanism in the Siemens analyzer prevents the results from being reported when humidity exposure is detected. In a controlled study, the analyzer can prevent false reports and produce error messages instead of producing results.
The CLINITEK Status+ analyzer and Siemens MULTISTIX 10 SG urine analysis test strips combined with Auto-Checks technology can automatically detect test strips that may be affected by excessive humidity.
The CLINITEK Status+ Analyzer not only detects MULTISTIX 10 SG test strips that are affected by excessive humidity, but it also prevents the reporting of potentially inaccurate results.
Roche and Diagnostic Test Group analyzers do not have a humidity detection system. Although the test strip is affected by excessive humidity, these two instruments report the results of the patient sample. The reported results may be wrong, because even for the same patient sample, the analyte results will differ between unexposed (unstressed) and exposed (stressed) test strips.
In various evaluations of the laboratory, Crolla and his team observed that most of the time the cap of the urine strip bottle was partially or completely removed. The analysis emphasizes the necessity of testing entities so that the individual manufacturer’s recommendations can be strongly implemented to keep the tape container covered when the tape is not removed for further analysis.
In situations where there are many operators (which makes establishing compliance quite complicated), it is also beneficial to use a system to notify the tester of an affected stripe so that the test cannot be performed.
Made from materials originally created by Lawrence Crolla, Cindy Jiménez, and Pallavi Patel from Northwest Community Hospital in Arlington Heights, Illinois.
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Siemens Healthineers Point of Care diagnosis. (2020, March 13). A comparative study of three urine analyzers, used to evaluate the automatic humidity check of the urine analyzer strips read by the instrument. News-Medical. Retrieved on July 13, 2021 from https://www.news-medical.net/whitepaper/20180123/A-Comparative-Study-of-Three-Urinalysis-Analyzers-for-Evaluation-of-Automated-Humidity-Check- for -Instrument-Read-Urinalysis-Strips.aspx.
Siemens Healthineers Point of Care diagnosis. “Comparative study of three urine analyzers used to evaluate the automatic humidity check of the urine analysis strip by the instrument reading”. News-Medical. July 13, 2021. .
Siemens Healthineers Point of Care diagnosis. “Comparative study of three urine analyzers used to evaluate the automatic humidity check of the urine analysis strip by the instrument reading”. News-Medical. https://www.news-medical.net/whitepaper/20180123/A-Comparative-Study-of-Three-Urinalysis-Analyzers-for-Evaluation-of-Automated-Humidity-Check-for-Instrument-Read-Urinalysis- Strip .aspx. (Accessed July 13, 2021).
Siemens Healthineers Point of Care diagnosis. 2020. A comparative study of three urine analyzers used to evaluate the automatic humidity check of the urine analysis strip by the instrument reading. News-Medical, viewed July 13, 2021, https://www.news-medical.net/whitepaper/20180123/A-Comparative-Study-of-Three-Urinalysis-Analyzers-for-Evaluation-of-Automated- Humidity-Check -for-Instrument-Read-Urinalysis-Strips.aspx.
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Post time: Jul-14-2021