• Title/Summary/Keyword: test specificity

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Detection of Methicillin-resistant Staphylococcs aureus from the Anterior Nares of Healthcare Workers in a Intensive Care Unit by Using PBP2a Rapid Kit and Direct Coagulase Test (중환자실에 근무하는 의료인의 전비강에서 PBP2a Rapid Kit와 직접 Coagulase 검사를 이용한 Methicillin-resistant Staphylococcus aureus의 검출)

  • Hong, Seung-Bok;Shin, Kyung-A;Son, Jae-Cheol;Shin, Seob-Kyeong
    • Korean Journal of Clinical Laboratory Science
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    • v.42 no.2
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    • pp.86-91
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    • 2010
  • We evaluated the performance of a novel screening test, PBP2a MRSA rapid kit (Dinona Inc., Iksan, Korea), for methicillin-resistant Staphylococcus aureus (MRSA) based on a immunochromatographic assay. The test is able to detect penicillin-binding protein 2a (PBP2a) using the nasal specimens from health care workers. The nasal specimens were obtained from 69 healthcare workers and were incubated in enrichment broth followed eight hours incubatin in BHI with cefoxitin $4{\mu}g/mL$. These broth were tested by PBP2a Rapid Kit. The enrichment broths were also directly tested for tube coagulase using the conventional identification method. 19 of 22 MRSA showed positive results by PBP2a rapid test and direct coagulase test (the sensitivity for detection of MRSA, 86.36%). While, 8 of 47 non-MRSA showed false positive results for the two tests. All of the 8 non-MRSA which showed false positive were co-colonizing isolates with MRCNS and MSSA. In addition, 46 of 49 methicillin-resistant staphylococci (MRS) showed positive results for PBP2a MRSA rapid kit (the sensitivity for detection of MRS, 93.8%), and all of 20 non-MRS showed negative results (specificity, 100%). The combination of PBP2a MRSA rapid kit and direct coagulase test showed the good sensitivity for detection of MRSA from anterior nares but frequently showed false positive results from the co-colonizing carrier with MRCNS and MSSA.

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Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex (고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발)

  • Lee, Tae-Woong;Jeong, Rae-Seok;Jeong, Seung-A;Kim, Jeong-Hyun;Shim, Young-Hun;Kim, In-Kyu;Park, Chang-Won
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.226-233
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    • 2013
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC). So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tablets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Ministry of Food and Drug Safety (MFDS). The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to establish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.

Effects of Visual Perception Skills on Driving Performance of Patients With Stroke (뇌졸중 환자의 시지각 능력이 운전수행에 미치는 영향)

  • Kwak, Ho-Soung
    • Therapeutic Science for Rehabilitation
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    • v.9 no.1
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    • pp.45-55
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    • 2020
  • Objective : The purpose of this study was to investigate the effects of visual perception on driving performance and the importance of visual training for improving driving performance in patients with stroke. Methods : The evaluations, using MVPT(Motor-free Visual Perception Test), TMT A&B(Trail Making Test A & B), UFOV(Useful Field Of View test), and a driving simulator, were carried out with patients in department of physical medicine and rehabilitation in a rehabilitation hospital from October 2014 to November 2014. Results : Driving performance was related to the ability of various visual perceptions of patients with stroke, and the highest correlation was found in the UFOV subtest 2, TMT B, and MVPT. The results of discriminant analysis indicated a sensitivity of 100.0%, specificity of 80.0%, and predicted the results of the driving simulator with 89.5% accuracy. Conclusion : This study found that visual-perception skills influence driving performance and suggested the importance of visual-perception skill training for driving.

Resazurin Reduction Time Test to Determine Post-pasteurization Contamination and Shelf Life of Market Milk (시유의 2차오염과 저장가능기간을 결정하기 위한 Resazurin 환원시간검사)

  • Choi, S,H.;Choi, J.J.;Lee, S.B.;Yoon, Y.H.
    • Journal of Animal Science and Technology
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    • v.46 no.6
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    • pp.999-1006
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    • 2004
  • The selective media including NPC agar, DHL agar, MacConkey agar, and Cetrimide desoxycholate agar were compared to determine selectivity for the growth of bacteria Cetrimide desoxycholate agar was better than NPC agar, DHL agar, and MacConkey agar for the growth of psychrotrophic grarn-negatve bacteria including Pseudomonas. and for the inhibition of gram positive bacteria The specificity of resazurin reduction time test was investigated to determine post-pasteurization contamination of market milk. Equal volume of Cetrimide desoxycholate broth was added to market milk, which was then incubated at $21^{\circ}C$ for 18 hours. The growth of bacteria in the incubated milk was detected in resazurin reduction time test. The results in resazurin reduction time test and total bacteria number count of market milk after storage at $7^{\circ}C$ were relatively correlated each other. Pseudomonas was isolated most frequently from the market milk stored at $7^{\circ}C$ for 10 days, and Acinetobacter and Aeromonas followed. Acinetobacter, Pseudomonas and Enterobacter were frequently isolated from the mixture of market milk and Cetrimide desoxycholate broth incubated at $21^{\circ}C$ for 18hours in resazurin reduction time test.

A CLINICAL STUDY FOR CARIES ACTIVITY OF PRESCHOOL CHILDREN USING CARIOSTAT (Cariostat를 이용한 아동의 우식활동에 관한 임상적 연구)

  • Baik, Byeong-Ju;Yang, Jeong-Suk;Lee, Young-Su;Yang, Yeon-Mi;Kim, Jae-Gon
    • Journal of the korean academy of Pediatric Dentistry
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    • v.25 no.3
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    • pp.576-582
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    • 1998
  • The purpose of the study was to determine the ability of the caries activity test, 'Cariostat' to identify preschool children with dental caries. The subjects of this study were 76 children of 3 to 5 years of age. Oral examination was carried out to assess the caries experience using a mirror and explorer. In all subjects buccal plaque samples were obtained, incubated, and scored as the manufacturer's instructions for the Cariostat test. Statistical analyses were used with the Crosstabulation. The test group exhibited mean dft index 5.21, while 27.63% of subjects were caries free and had no restorations. The sensitivity of the Cariostat test was found to be 98.8% while the specificity was found to be 19.05% The results showed that caries activity measured by visual reading was highly significant to the Cariostat score and dft index(P<0.001). The Cariostat method has indicated the future possible occurrence of caries. The use of this method is meant to require in the caries prevention program.

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Evaluation of Eye Irritation Potential of Solid Substance with New 3D Reconstructed Human Cornea Model, MCTT HCETM

  • Jang, Won-hee;Jung, Kyoung-mi;Yang, Hye-ri;Lee, Miri;Jung, Haeng-Sun;Lee, Su-Hyon;Park, Miyoung;Lim, Kyung-Min
    • Biomolecules & Therapeutics
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    • v.23 no.4
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    • pp.379-385
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    • 2015
  • The eye irritation potential of drug candidates or pharmaceutical ingredients should be evaluated if there is a possibility of ocular exposure. Traditionally, the ocular irritation has been evaluated by the rabbit Draize test. However, rabbit eyes are more sensitive to irritants than human eyes, therefore substantial level of false positives are unavoidable. To resolve this species difference, several three-dimensional human corneal epithelial (HCE) models have been developed as alternative eye irritation test methods. Recently, we introduced a new HCE model, MCTT HCE$^{TM}$ which is reconstructed with non-transformed human corneal cells from limbal tissues. Here, we examined if MCTT HCE$^{TM}$ can be employed to evaluate eye irritation potential of solid substances. Through optimization of washing method and exposure time, treatment time was established as 10 min and washing procedure was set up as 4 times of washing with 10 mL of PBS and shaking in 30 mL of PBS in a beaker. With the established eye irritation test protocol, 11 solid substances (5 non-irritants, 6 irritants) were evaluated which demonstrated an excellent predictive capacity (100% accuracy, 100% specificity and 100% sensitivity). We also compared the performance of our test method with rabbit Draize test results and in vitro cytotoxicity test with 2D human corneal epithelial cell lines.

Location and Urban Network Hierarchy Analysis of the Seven Major Test and Certification Institutions in Korea (시험인증 기관의 입지 및 도시 네트워크 위계 분석: 국내 7대 시험인증기관을 대상으로)

  • Hong, Sung-Ho;Kim, Jung-Eun
    • Journal of the Economic Geographical Society of Korea
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    • v.25 no.3
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    • pp.380-396
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    • 2022
  • In this study, the location and network hierarchy of the seven major test and certification institutions in Korea were analyzed. First, like other APS, the test and certification institutions are concentrated in the metropolitan area, and the spatial spread of the branch is developing. Second, unlike other APS, branches do not accumulate in large cities. It is deeply related to regional economic geography characteristics such as proximity to manufacturers and specificity of regional strategic industries. Third, despite the spatial spread, workers are concentrated in the metropolitan area. Fourth, urban-regions are mainly formed between the metropolitan area of test certification and the Chungbuk(Cheong) area.

Are Accuracy Studies for Periprosthetic Joint Infection Diagnosis Inherently Flawed? And What to Do with Schrödinger's Hips? A Prospective Analysis of the Alpha Defensin Lateral-Flow Test in Chronic Painful Hip Arthroplasties

  • Jesse W.P. Kuiper;Steven J. Verberne;Pim W. van Egmond;Karin Slot;Olivier P.P. Temmerman;Constantijn J. Vos
    • Hip & pelvis
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    • v.34 no.4
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    • pp.236-244
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    • 2022
  • Purpose: The most recent diagnostic criteria for periprosthetic joint infection (PJI) include the use of the alpha-defensin (AD) lateral-flow (LF) test, but hip and knee arthroplasties were usually combined in previous studies. This prospective study was designed to examine the accuracy of the AD-LF test for diagnosis of PJI in chronic painful total hip arthroplasties (THA). Materials and Methods: Patients with chronic painful hip arthroplasties were prospectively enrolled between March 2018 and May 2020. Exclusion criteria included acute PJI or an insufficient amount of synovial fluid. The modified Musculoskeletal Infection Society (MSIS) criteria were primarily used for PJI diagnosis. Fifty-seven patients were included in the analysis group. Revision surgery was not performed in 38 patients, for different reasons (clinical group); these patients remain "Schrödinger's hips": in such cases PJI cannot be excluded nor confirmed until you "open the box". Results: The result of the AD-LF test was positive in nine patients and negative in 48 patients. Six patients were diagnosed with PJI. AD-LF sensitivity (MSIS criteria) was 83% (95% confidence interval [CI] 36-100%) and specificity was 92% (95% CI 81-98%). The positive and negative predictive value were 56% and 98%, respectively. Conclusion: The AD test is useful in addition to the existing arsenal of diagnostic tools, and can be helpful in the decision-making process. Not all patients with chronical painful THA will undergo revision surgery. Consequently, in order to determine the reliable diagnostic accuracy of this test, future PJI diagnostic studies should include a second arm of "Schrödinger's hips".

The Role of Serum Pepsinogen in Detection of Gastric Cancer (위암 검출에서 혈중 Pepsinogen검사의 의의)

  • Ryu, Hyong-Kyun;Park, Jeon-Woo;Lee, Keon-Ho;Jeon, Chang-Ho;Lee, Ho-Joon;Chae, Hyun-Dong
    • Journal of Gastric Cancer
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    • v.9 no.4
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    • pp.167-171
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    • 2009
  • Purpose: This study was done to determine the usefulness of serum pepsinogen (PG) levels as a screening method for gastric cancer, and to assess the relationships between serum PG and clinicopathologic factors of gastric adenocarcinoma. Materials and Methods: Serum PG concentrations were measured in 94 subjects who were classified into (a) a control group (50 subjects) without abnormal endoscopic finding on a health checkup, or (b) a gastric cancer group (44 subjects) who had surgery at Daegu Catholic University Hospital between Nov. 2008 and May 2009. Receiver operator characteristic curves were utilized to select the most suitable test. Using different cutoff points, sensitivity and specificity were calculated. We compared preoperative serum PG levels with several clinicopathologic findings for patients with gastric adenocarcinoma. Results: The Serum PG I:II ratio was the most useful as a screening test. The sensitivity and specificity of PG screening for gastric cancer were, respectively, 81.8% and 82%. The cut off point correlated with the type of intestinal cancer (Lauren classification; P=0.003), tumor stage (P=0.001), and gastric adenocarcinoma with peritumoral chronic atrophic gastritis (P=0.036). Conclusion: Serum PG levels were found to be a potentially useful screening test and to correlate with clinicopathologic factors in gastric cancer patients. But, in order to use serum PG found in a health checkup for gastric cancer as a clinical application a large scale study is recommended.

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Analytical method validation of oxiracetam using HPLC (HPLC를 이용한 의약품 주성분인 옥시라세탐의 Analytical Method Validation)

  • Kim, Yoo-Gon;Seo, Houng-Seok;Won, Chan-Hee
    • Analytical Science and Technology
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    • v.23 no.6
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    • pp.587-594
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    • 2010
  • This study aims to determine that the test of medicines containing oxiracetam as their main ingredient was properly performed according to protocol. Furthermore, the study is to provide the written form of protocol in order to examine the validity of the HPLC analytical method for the quantitative analysis of oxiracetam in the finished products. In this experiment, system suitability, precision, linearity, range, accuracy, specificity, quantitative limit, and detection limit of the analytical method which was used to determine the contained quality of oxiracetam, were examined. The result shows that system suitability indicates 0.127% RSD, plate number 15081, tailing factor 0.49, and resolution 32.41. The experiment of precision reveals the result of below 0.359% for repetitiveness and among the subjects. In the linearity experiment, a coefficient of correlation ($R^2$) indicates that it is 1. The accuracy experiment satisfies the standards of the recovery test, which is minimum 98.4% and maximum 99.6%. Detection limit is 0.1 mg/L and quantitative limit was found to be 0.5 mg/L. The experiment to check the specificity also satisfies the standards, so the finished product using oxiracetam as the main ingredient is verified as suitable.