Labmedicine最新文献_第8页

Hematology and Immunology: Quality in Laboratory Diagnosis 血液学和免疫学:实验室诊断的质量

4区医学

Labmedicine Pub Date : 2015-05-01 DOI: 10.1309/LM3C3EOK8UFALQOV

Cynthia S. Johns

引用次数: 0

Laboratory Management: Quality in Laboratory Diagnosis 实验室管理:实验室诊断的质量

4区医学

Labmedicine Pub Date : 2015-02-01 DOI: 10.1309/LMH0BBLXMPLLR8NQ

A. Kurec

引用次数: 2

Cases in Medical Microbiology and Infectious Diseases, Fourth Edition 医学微生物学和传染病案例，第四版

4区医学

Labmedicine Pub Date : 2015-02-01 DOI: 10.1309/LMHKL8HWSPZK1UE3

Lori D. Racsa

引用次数: 0

Neoplastic Lesions of the Skin 皮肤的肿瘤病变

4区医学

Labmedicine Pub Date : 2014-11-01 DOI: 10.1309/LMWLIB7MJOEHQ7F5

C. Shea

引用次数: 2

Transfusion Medicine: Quality in Laboratory Diagnosis 输血医学:实验室诊断的质量

4区医学

Labmedicine Pub Date : 2014-08-01 DOI: 10.1309/LMH50MK9NSEYFQUM

Kathy J. Kaherl

引用次数: 0

Clinical Chemistry: Quality in Laboratory Diagnosis 临床化学:实验室诊断的质量

4区医学

Labmedicine Pub Date : 2014-08-01 DOI: 10.1309/LMULTEZPIYM6B06B

M. Mayo

引用次数: 2

Creating a Molecular Atmosphere: Phase 2 创造分子氛围:第二阶段

4区医学

Labmedicine Pub Date : 2014-05-01 DOI: 10.1309/LMGGQP14B4MNIIZX

S. Wallace

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引用次数: 1

Creating a Molecular Atmosphere: Phase 3 创造分子氛围:第三阶段

4区医学

Labmedicine Pub Date : 2014-05-01 DOI: 10.1309/LM63S2LECGCGAZJD

S. Wallace

{"title":"Creating a Molecular Atmosphere: Phase 3","authors":"S. Wallace","doi":"10.1309/LM63S2LECGCGAZJD","DOIUrl":"https://doi.org/10.1309/LM63S2LECGCGAZJD","url":null,"abstract":"The use of laboratory-developed tests (LDT) was unfamiliar to me before I started to create this molecular atmosphere within our microbiology department at the System Laboratory of OSF Saint Francis Medical Center. My experience with diagnostic testing had usually included using a kit containing a product insert with step-by-step instructions on how to perform the test in question. However, the herpes simplex virus (HSV) assay and Bordetella pertussis/parapertussis (hereafter, Bordetella) test performed via real-time PCR needed to be developed, validated, and verified; protocols needed to be written based on the steps that we found to be successful.\u0000\u0000LDTs, also known as home-brew tests, are developed in-house and used for research or diagnostic purposes. LDTs are not frequently encountered in certified clinical laboratories; they are more commonly found in research-based facilities. This type of assay has not been approved by the United States Food and Drug Administration (FDA), so no commercial kits are available. Laboratories that create home-brew assays can make the reagents themselves or buy reagents from outside vendors and develop their own protocol for testing. The validation … \u0000\u0000[↵][1]* To whom correspondence should be addressed. E-mail: stephanie.e.wallace{at}osfhealthcare.org\u0000\u0000 [1]: #xref-corresp-1-1","PeriodicalId":54328,"journal":{"name":"Labmedicine","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2014-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89772125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Creating a Molecular Atmosphere, Phase 5 创造分子气氛，第五阶段

4区医学

Labmedicine Pub Date : 2014-05-01 DOI: 10.1309/LMEREIQGW1CSZZA4

S. Wallace

{"title":"Creating a Molecular Atmosphere, Phase 5","authors":"S. Wallace","doi":"10.1309/LMEREIQGW1CSZZA4","DOIUrl":"https://doi.org/10.1309/LMEREIQGW1CSZZA4","url":null,"abstract":"As mentioned in previous articles in this series, product inserts are available with most FDA-approved assays. These product inserts contain information about the product as well as explain processes and procedures approved by the manufacturer of the assay. Included in these procedures are quality control (QC) recommendations. Some FDA-approved assays have QC material included in the packaging of test materials; others suggest from whom to purchase the quality control material and provide recommendations on how to use it.\u0000\u0000For all of the assays that we perform on the Infinity (Thermo Fisher Scientific, Waltham, MA) instrument, we routinely perform external QC on new lots and new shipments. All of these assays are FDA-approved, qualitative, and include a built-in internal control for every patient test that is performed. Because the internal control is present, we are not required to perform external QC procedures with every patient specimen. The external controls used for these assays are purchased from a manufacturer and can be used directly or after a simple dilution is made.\u0000\u0000The assays we perform on the SmartCycler (Cepheid, Sunnyvale, CA) are laboratory developed; therefore, control materials are not commercially available in ready-to-use form. Clinical Laboratory Standards Institute (CLSI) and College of American Pathologist (CAP) guidelines suggest that laboratorians ensure that a control is present throughout the entirety of a patient testing procedure. If an internal control cannot be present from start to finish, external-control material must be included in every patient-testing procedure.\u0000\u0000For herpes simplex virus (HSV) external control, we purchase stock virus from a manufacturer. We grow the virus in shell vials, in a similar manner that we would use for controls when setting up HSV cultures. This growth of virus in shell vials takes anywhere from 3 to 5 days to yield a 90% or greater cytopathic effect (CPE). … \u0000\u0000[↵][1]* To whom correspondence should be addressed. E-mail: stephanie.e.wallace{at}osfhealthcare.org\u0000\u0000 [1]: #xref-corresp-1-1","PeriodicalId":54328,"journal":{"name":"Labmedicine","volume":"2010 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2014-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86316387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Medically Important Fungi: A Guide to Identification – 5th Edition 医学上重要的真菌:鉴定指南第5版

4区医学

Labmedicine Pub Date : 2014-05-01 DOI: 10.1309/LMW8AT6W4EUIXYBP

G. Procop

引用次数: 3