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Feasibility of the Routine Clinical Use of a Multiplex Virus Polymerase Chain Reaction Assay Based on Blood Virus Detection in Hematopoietic Stem Cell-Transplanted Patients

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International Journal of Clinical Medicine 2022年第2期13卷 67-81页

作者： Hiroko Tsunemine Miho Sasaki Yuriko Zushi Toshiharu Saitoh Norio Shimizu Yasuhiro Tomaru Yumi Aoyama Ryusuke Yamamoto Tomomi Sakai Nobuyoshi Arima Taiichi Kodaka Takayuki Takahashi Departments of Hematology Shinko Hospital Kobe Japan Cell Therapy Shinko Hospital Kobe Japan Center for Stem Cell and Regenerative Medicine Tokyo Medical and Dental University Tokyo Japan Akasaka Hematology & Oncology Clinic Kobe Japan

Background: Multiplex virus assays are useful in immunocompromised hosts but still challenging in routine clinical settings in terms of their sensitivity, specificity, reproducibility, and time and cost performances. In recent years, we developed a qualitative multiplex virus PCR assay capable of the simultaneous detection of 13 virus species within 3 h. However, because of the multiple and concomitant nature of this virus assay, it should be validated for qualitative reliability. Materials and Methods: As a preclinical examination, this multiplex PCR was able to detect 1.25 × 103 copies/mL of 13 synthesized virus genomes and preserved same virus DNAs by the serial dilution method. Blood samples from 40 patients who underwent hematopoietic stem cell transplantation were then examined by multiplex PCR for 13 virus species, followed by quantitative real-time PCR for all 13 virus species as reference PCR when these patients developed symptoms suggestive of viral infection. Results: In 421 cumulative qualitative-quantitative tests, the multiplex PCR certainly detected 1.0 × 103 copies/mL of 5 viruses (CMV, JCV, BKV, HHV-6, ADV) that were frequently detected and thus reasonably analyzed. The positive and negative predictive values of multiplex PCR were 84.2% - 93.3% and 90.7% - 99.0%, respectively, and sensitivity and specificity were 59.0% - 83.3% and 97.2% - 99.2%, respectively, for these 5 viruses. Conclusion: From these performances, the multiplex PCR assay may be acceptable in a routine clinical laboratory setting.

关键词： Multiplex Virus PCR Assay Routine Laboratory Use positive predictive value Negative predictive value Sensitivity Specificity

Evaluation of the immunochromatographic strip test for the rapid diagnosis of antenatal syphilis in women in Eldoret,Kenya

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Journal of Nanjing Medical University 2009年第5期23卷 317-321页

作者： Lydia B. Nyamwamu Michael M. Gicheru Rekha R. Sharma lbert Kimutai Willy K.Tonui Peter Kamau Ngure Department of Zoological Sciences Kenyatta University P.O.BOX 43844 NairobiKenya Department of Zoological Sciences Kenyatta University P.O.BOX 43844 NairobiKeny Centre for Biotechnology Research and Development Kenya Medical Research Institute P.O.Box 54844-00200NairobiKenya Centre for Biotechnology Research and Development Kenya Medical Research Institute P.O.Box 54844-00200NairobiKeny Science Department Daystar UniversityP.O.Box 44400-00100NairobiKenya

Objective： This study compared the performance of the immunochromatographic strip （ICS） to the Venereal Disease Research Laboratory （VDRL） test and Treponema pallidum haemagglutination assay （TPHA） at a primary health care setting. Methods： The study group was comprised of 150 females randomly drawn from a population of pregnant women attending their first antenatal visit or follow-up visits at West Maternity Hospital in Eldoret Kenya, but without a previous syphilis test during that pregnancy. On-site VDRL, ICS and TPHA tests were performed and immediate treatment provided where appropriate. The performance of the three tests was compared, Results： The sero-prevalence of syphilis as determined by the VDRL test was 3%. There was no significant difference between the ICS and the VDRL test （P 〉 0.05）. The sensitivity and specificity of the ICS test were 80% and 98.6% respectively, while the negative predictive value （NPV） and positive predictive value （PPV） were both 100%. On the other hand, the sensitivity and specificity of the VDRL test were 66.7% and 99.3%, while the NPV and PPV were 80% and 98.6% respectively. The Treponema pallidum haemagglutination assay was used as a reference test and had sensitivity, specificity, NPV and PPV of 100%. Conclusion： The diagnostic accuracy of the ICS compared favorably with theVDRL gold standard. The use of the ICS in Kenya can improve the diagnosis of syphilis in health facilities both with and without laboratories and allow community health care workers to make a rapid diagnosis of the disease, and consequently make immediate therapeutic decisions.

关键词： Syphilis Immunochromatographic strip test Venereal Disease Research Laboratory Treponema Pa//idum haemagglutinationAssay Specificity Sensitivity positive predictive value Negative predictive value antenatal syphilis

predictive power of statistical significance

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World Journal of Methodology 2017年第4期7卷 112-116页

作者： Thomas F Heston Jackson M King Department of Family Medicine University of Washington Department of Medical Education and Clinical Sciences Elson S. Floyd College of Medicine Washington State University

A statistically significant research finding should not be defined as a P-value of 0.05 or less, because this definition does not take into account study power. Statistical significance was originally defined by Fisher RA as a P-value of 0.05 or less. According to Fisher, any finding that is likely to occur by random variation no more than 1 in 20 times is considered significant. Neyman J and Pearson ES subsequently argued that Fisher's definition was incomplete. They proposed that statistical significance could only be determined by analyzing the chance of incorrectly considering a study finding was significant(a Type Ⅰ?error) or incorrectly considering a study finding was insignificant(a Type Ⅱ error). Their definition of statistical significance is also incomplete because the error rates are considered separately, not together. A better definition of statistical significance is the positive predictive value of a P-value, which is equal to the power divided by the sum of power and the P-value. This definition is more complete and relevant than Fisher's or Neyman-Peason's definitions, because it takes into account both concepts of statistical significance. Using this definition, a statistically significant finding requires a P-value of 0.05 or less when the power is at least 95%, and a P-value of 0.032 or less when the power is 60%. To achieve statistical significance, P-values must be adjusted downward as the study power decreases.

关键词： Statistical significance positive predictive value Biostatistics Clinical significance Power

Evaluation of Sensitivity and positive predictive values of Cytopathologic Diagnosis of Solid Masses in Dogs

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Open Journal of Veterinary Medicine 2016年第6期6卷 95-98页

作者： Richard M. Kabuusu Tracy Volger Sachin Kumthekar Keshaw Tiwari Alfred Chikweto Muhammad I. Bhaiyat Claude De Allie Ruth Alexander Carla Richards Ravindra N. Sharma Department of Pathobiology School of Veterinary Medicine St. George’s University St. George’s West Indies

In this retrospective study, a total of 275 solid masses were examined for cytopathologic diagnosis. Twenty four percent (67/275) of these cytologic samples were followed by surgical biopsy and histopathologic diagnosis, allowing for comparisons. On average, the cutaneous and subcutaneous solid masses were recognized when the dogs were aged between 6 and 9 years old. The origins of the solid masses included connective tissue tumors 37.1% (23/62), epithelial tissue tumors 33.9% (21/62), round cell tumors 19.4% (12/62), masses of inflammatory lesions 4.8% (3/62) and lesions due to other causes 4.8% (3/62). The sensitivity and positive predictive value (PPV) of cytopathology in the diagnosis of solid masses were 93% (62/67) and 97% (62/64), respectively. Generally, neo-plasms were over diagnosed by cytopathology as was indicated by the positive predictive value. Both the sensitivity and the PPV of cytopathology comparative to histopathology in the diagnosis of inflammatory processes were 100% (3/3). The inflammatory lesions were eventually confirmed as necrotizing myositis, necro-suppurative cystitis and endocrine inflammatory dermatopathy based on histopathology. Less than 8% (5/67) of samples were incorrectly diagnosed by cytology. The study showed high accuracy between cytological and histopathological examination of solid masses in dogs, and thus a reliable diagnostic tool in patient care.

关键词： Cytopathology Histopathology Dog Sensitivity positive predictive value Solid Masses

A new likelihood approach to inference about predictive values of diagnostic tests in paired designs

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A new likelihood approach to inference about predictive valu...