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BACKGROUND: The existing respiratory fit test panels (RFTPs) are based on Bivariate and Principal Component Analysis (PCA) which utilise American and Chinese head and facial dimensions. As RFTPs based on local facial anthropometric data for Malaysia are not available, this study was conducted with the aim to develop new RFTPs using Malaysian data. METHODOLOGY: A cross-sectional study was conducted across Malaysia among 3,324 participants of the study of National Health and Morbidity Survey 2020 aged 18 and above. Ten head and facial dimensions were measured. Face length and face width were used to construct bivariate facial panel, whereas the scores from the first two PCA were used to develop the PCA panel. RESULTS: This study showed that Malaysians have the widest upper limit for facial width. It also found that three factors could be reduced from the PCA analysis. However only 2 factors were selected with PCA 1 representing head and facial size and PCA 2 representing facial shape. Our bivariate panel could accommodate 95.0% of population, while our PCA panel accommodated 95.6%. CONCLUSION: This was the first study to use Malaysian head and facial anthropometry data to create bivariate and PCA panels. Respirators constructed using these panels are likely to fit ≥ 95.0% of Malaysia's population.

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Objective:To develop a list of basic and expanded medical laboratory tests in community health service centers in Shanghai.Methods:The status quo of human and equipment resource allocation, the test items and quality control currently performed, the perspectives of various stakeholders, the capacity building of community clinical laboratory in community health service centers in Shanghai were investigated by quantitative survey and qualitative interview; and the rating scores of each test item were assessed by expert consultation using Delphi method. The expert focus discussion was conducted, and each test item was rated and classified. Finally a list of the basic tests and expanded tests in clinical laboratories of community health service center was developed.Results:A total of 247 questionnaires were distributed and 192 (77.7%) were answered. A list of 94 laboratory test items was screened out based on the questionnaire survey of the laboratories of the community health centers. Thirty one experts in the relevant areas were invited to rate the test items, the average authority coefficient of experts was 0.90, with which the weighted average of the expert ratings was made. There were 45 (47.9%) items scored 7 or higher, 38 (40.4%) scored between 5 and 7, and 11 (11.7%) scored less than 5. Based on the results of the expert focus discussion, 48 items were recommended as the basic tests and 46 items as the extended tests.Conclusion:In this study a list of tests recommended to clinical laboratories in Shanghai community health service centers has been developed, which contains 48 basic tests and 46 extended tests.

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Objectives: The use of specific test panels (STP) for heart failure (HF) could help improve the management of this condition. The purpose of this study is to gain an insight into the level of implementation of STPs in the management of HF in Spain and gather the opinions of experts, with a special focus on parameters related to iron metabolism. Methods: The opinions of experts in HF were gathered in three stages STAGE 1 as follows: level of implementation of STPs (n=40). STAGE 2: advantages and disadvantages of STPs (n=12). STAGE 3: level of agreement with the composition of three specific STPs for HF: initial evaluation panel, monitoring panel, and de novo panel (n=16). Results: In total, 62.5% of hospitals used STPs for the clinical management of HF, with no association found between the use of STPs and the level of health care (p=0.132) and location of the center (p=0.486) or the availability of a Heart Failure Unit in the center (p=0.737). According to experts, the use of STPs in clinical practice has more advantages than disadvantages (8 vs. 3), with a notable positive impact on diagnostics. Experts gave three motivations and found three limitations to the implementation of STPs. The composition of the three specific STPs for HF was viewed positively by experts. Conclusions: Although the experts interviewed advocate the use of diagnostic and monitoring STPs for HF, efforts are still necessary to achieve the standardization and homogenization of test panels for HF in Spanish hospitals.

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Currently, there is a constant expansion of the range of narcotic substances that differ from each other by a small structural fragment. The option of determining narcotic substances using test panels is widespread due to its rapidity and high specificity through the use of immunochemical reactions. The purpose of the study was to optimize the determination of morphine and amphetamine in bioobjects (synthetic and natural urine) using immunochromatographic analysis with new test panels and to select the optimal conditions for mass analysis. Test panels were used to detect the presence of amphetamine and morphine. For color recording of the results of analysis, colloidal gold nanoparticles were used. The principle of operation of these test panels is described. The sensitivity of the test panels is such that it is possible to avoid false-positive results. It was found that with the help of test panels it is possible to determine narcotic substances in a concentration lower than stated in the instructions (300 ng/ml). The actual detection limit for amphetamine was 75 ng/ml and morphine 100 ng/ml. The analytical characteristics of the developed metho-dology were determined: detection limit, precision, truth and specificity. The specificity was proved by conducting ICA to detect the presence of cross-reactions of test systems to amphetamine and morphine using structural analogues - adrenaline 1000 and codeine 300, respectively. The study did not receive false positive results for these molecules using the proposed test panels. Immunochromatographic test systems are optimal for drug detection, especially when conducting mass studies.

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PURPOSE: Several genes on hereditary breast and ovarian cancer susceptibility test panels have not been systematically examined for strength of association with disease. We employed the Clinical Genome Resource (ClinGen) clinical validity framework to assess the strength of evidence between selected genes and breast or ovarian cancer. METHODS: Thirty-one genes offered on cancer panel testing were selected for evaluation. The strength of gene-disease relationship was systematically evaluated and a clinical validity classification of either Definitive, Strong, Moderate, Limited, Refuted, Disputed, or No Reported Evidence was assigned. RESULTS: Definitive clinical validity classifications were made for 10/31 and 10/32 gene-disease pairs for breast and ovarian cancer respectively. Two genes had a Moderate classification whereas, 6/31 and 6/32 genes had Limited classifications for breast and ovarian cancer respectively. Contradictory evidence resulted in Disputed or Refuted assertions for 9/31 genes for breast and 4/32 genes for ovarian cancer. No Reported Evidence of disease association was asserted for 5/31 genes for breast and 11/32 for ovarian cancer. CONCLUSION: Evaluation of gene-disease association using the ClinGen clinical validity framework revealed a wide range of classifications. This information should aid laboratories in tailoring appropriate gene panels and assist health-care providers in interpreting results from panel testing.

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Objective:To investigate the skin irritation of essential oils(EOs) extracted from interior-warming medicines. Method:Three EOs from interior-warming medicines(Cinnamomi Cortex, Caryophylli Flos and Alpiniae Officinarum Rhizoma) were selected as research objects.The in vitro skin cytotoxicity and in vivo skin irritation of these EOs were determined and compared.Moreover, the skin irritation was also predicted by the novel skin test panels. Result:Toxicity of these three EOs to human skin fibroblasts(HSF) was significantly different, half-inhibitory concentration(IC50) values of EOs from Cinnamomi Cortex, Alpiniae Officinarum Rhizoma and Caryophylli Flos were (11.16±0.28), (53.33±1.71), (226.70±17.61) mg·L-1, respectively.However, in vivo skin irritation evaluation showed that the local toxicity of these three EOs was in the order of EO of Cinnamomi Cortex > EO of Caryophylli Flos > EO of Alpiniae Officinarum Rhizoma. The evaluation results of skin test panels for these three EOs were in accordance with the results of in vivo skin irritation evaluation. Conclusion:Toxicity of these three EOs against skin cells in vitro is inconsistent with their in vivo skin irritation. Skin test panels are expected to be able to accurately predict in vivo skin irritation of EOs instead of cytotoxicity evaluation.

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We considered the application of MALDI-TOF mass spectrometry for BSL-3 bacterial diagnostics, with a focus on the biosafety of live-culture direct-colony testing and the stability of stored extracts. Biosafety level 2 (BSL-2) bacterial species were used as surrogates for BSL-3 high-consequence pathogens in all live-culture MALDI-TOF experiments. Viable BSL-2 bacteria were isolated from MALDI-TOF mass spectrometry target plates after 'direct-colony' and 'on-plate' extraction testing, suggesting that the matrix chemicals alone cannot be considered sufficient to inactivate bacterial culture and spores in all samples. Sampling of the instrument interior after direct-colony analysis did not recover viable organisms, suggesting that any potential risks to the laboratory technician are associated with preparation of the MALDI-TOF target plate before or after testing. Secondly, a long-term stability study (3 years) of stored MALDI-TOF extracts showed that match scores can decrease below the threshold for reliable species identification (<1.7), which has implications for proficiency test panel item storage and distribution.

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This study aimed to quantify the variability between different anthropometric panels in determining the inward leakage (IL) of N95 filtering facepiece respirators (FFRs) and elastomeric half-mask respirators (EHRs). We enrolled 144 experienced and non-experienced users as subjects in this study. Each subject was assigned five randomly selected FFRs and five EHRs, and performed quantitative fit tests to measure IL. Based on the NIOSH bivariate fit test panel, we randomly sampled 10,000 pairs of anthropometric 35 and 25 member panels without replacement from the 144 study subjects. For each pair of the sampled panels, a Chi-Square test was used to test the hypothesis that the passing rates for the two panels were not different. The probability of passing the IL test for each respirator was also determined from the 20,000 panels and by using binomial calculation. We also randomly sampled 500,000 panels with replacement to estimate the coefficient of variation (CV) for inter-panel variability. For both 35 and 25 member panels, the probability that passing rates were not significantly different between two randomly sampled pairs of panels was higher than 95% for all respirators. All efficient (passing rate ≥80%) and inefficient (passing rate ≤60%) respirators yielded consistent results (probability >90%) for two randomly sampled panels. Somewhat efficient respirators (passing rate between 60% and 80%) yielded inconsistent results. The passing probabilities and error rates were found to be significantly different between the simulation and binomial calculation. The CV for the 35-member panel was 16.7%, which was slightly lower than that for the 25-member panel (19.8%). Our results suggested that IL inter-panel variability exists, but is relatively small. The variability may be affected by passing level and passing rate. Facial dimension-based fit test panel stratification was also found to have significant impact on inter-panel variability, i.e., it can reduce alpha and beta errors, and inter-panel variability.

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BACKGROUND: Laboratory tests in hospitals are among the most important diagnostic tools for medical decision making at the Emergency Department. They are often ordered as part of extended test panels, which, although helpful and convenient for doctors, may lead to overuse of tests and overdiagnosis. To improve the ordering process, we investigated which laboratory tests are essential for optimal decision making at the Emergency Department of our hospital. METHODS: Forty-nine doctors regularly involved with the Emergency Department filled in a questionnaire asking for their opinions on laboratory test ordering and use. RESULTS: A limited number of laboratory tests are considered indispensable for the Emergency Department: CRP and leukocytes, urea and creatinin, sodium and potassium, and haemoglobin. Glucose and troponin should probably also be included in this list, but were not mentioned as glucose is measured using portable point-of-care devices in our hospital, while cardiac patients are referred directly to the cardiac care unit. CONCLUSIONS: Only a limited number of laboratory tests are essential for early medical decision making at the Emergency Department. Ordering facilities should be arranged such that these tests are permanently available, easy to order, and performed with short turnaround times. Test panels for the ED should incorporate these essential tests, with additional other tests so as to prevent essential tests from being forgotten, maintain convenience for doctors and promote sensible and effective use of diagnostic testing. The outcome of these conflicting aims is a compromise, as is discussed.

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The test panels are combined for the clinical application according to the principle of the evidence-based medicine, which involves the strict evaluation for the technical performance, diagnostic performance, the result of patients and the economic properties. The guideline for the clinical application of the test panels is established in light of different diagnostic objectives and diseases, providing the best diagnostic service for the physicians and benefiting the patients the most.