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William Sause - One of the best experts on this subject based on the ideXlab platform.
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Variable Specimen Handling Affects Hormone Receptor Test Results in Women With Breast Cancer: A Large Multihospital Retrospective Study
Archives of Pathology & Laboratory Medicine, 2010Co-Authors: Flory L. Nkoy, M. Elizabeth H. Hammond, William Rees, Tom Belnap, Braden Rowley, Steve Catmull, William SauseAbstract:Abstract Context.—Intermountain Healthcare hospitals use a single, standardized laboratory and automated testing process for estrogen receptor/progesterone receptor (ER/PR) tests to minimize testing errors. Objectives.—To test the (1) variability in ER/PR negativity among hospitals and (2) association between Specimen Handling conditions and ER/PR negativity. Design.—Retrospective study of women who had breast cancer surgery at 7 Intermountain hospitals and ER/PR tests ordered between 1997 and 2003. Data were extracted from cancer registry. Frequency of ER/PR negativity was calculated for each surgery day and compared among hospitals and between 2 groups: regular (Specimens obtained Sunday through Thursday, more likely to be tested within 24 hours of surgery) and prolonged (Specimens obtained on Friday and Saturday, more likely to be tested more than 24 hours after surgery) Specimen Handling conditions. Results.—Five thousand seventy-seven women were tested for ER/PR. The frequency of ER and PR negativity was 20.9% and 27.9%, respectively. It increased with each day of the week for both ER (P = .03) and PR (P = .059) and tended to be higher for prolonged Specimens for ER (23.6% versus 20.4%; P = .03) and for PR (30.1% versus 27.4%; P = .11) compared with regular Specimens. After controlling for age and tumor size, both ER (P = .02) and PR (P = .02) negativity was significantly different among the hospitals and was associated with prolonged Specimens for ER (P = .04) but not for PR (P = .09). Conclusions.—Estrogen receptor and PR negativity remained highly variable among hospitals despite use of a single laboratory and tended to be significantly associated with prolonged Specimen Handling. More studies are needed to confirm these findings.
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Variable Specimen Handling Affects Hormone Receptor Test Results in Women With Breast Cancer: A Large Multihospital Retrospective Study
Archives of pathology & laboratory medicine, 2010Co-Authors: Flory L. Nkoy, Braden D. Rowley, M. Elizabeth H. Hammond, William Rees, Tom Belnap, Steve Catmull, William SauseAbstract:Abstract Context.—Intermountain Healthcare hospitals use a single, standardized laboratory and automated testing process for estrogen receptor/progesterone receptor (ER/PR) tests to minimize testin...
Puiyuen Wong - One of the best experts on this subject based on the ideXlab platform.
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evaluation of the architect urine ngal assay assay performance Specimen Handling requirements and biological variability
Clinical Biochemistry, 2010Co-Authors: Frank C Grenier, Salman Ali, Hina N Syed, Ryan F Workman, Frans Martens, Ming Liao, Y Wang, Puiyuen WongAbstract:Abstract Objectives: NGAL (Neutrophil Gelatinase-Associated Lipocalin) has emerged as a new biomarker for the identification of acute kidney injury. Reliable clinical evaluations require a simple, robust test method for NGAL, and knowledge of Specimen Handling and Specimen stability characteristics. We evaluated the performance of a new urine NGAL assay on the ARCHITECT analyzer. Methods: Assay performance characteristics were evaluated using standard protocols. Urine Specimen storage requirements were determined and biological variability was assessed in a self-declared apparently healthy population. Results: Assay performance data showed good precision, sensitivity and lot-to-lot reproducibility. There was good short term 2–8 °C sample stability, however, long term storage samples must be kept at − 70 °C or colder. The largest variance component in a biological variance study was within-day. Conclusions: The ARCHITECT NGAL assay proved to be a precise and reproducible assay for the determination of urine NGAL.
Flory L. Nkoy - One of the best experts on this subject based on the ideXlab platform.
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Variable Specimen Handling Affects Hormone Receptor Test Results in Women With Breast Cancer: A Large Multihospital Retrospective Study
Archives of Pathology & Laboratory Medicine, 2010Co-Authors: Flory L. Nkoy, M. Elizabeth H. Hammond, William Rees, Tom Belnap, Braden Rowley, Steve Catmull, William SauseAbstract:Abstract Context.—Intermountain Healthcare hospitals use a single, standardized laboratory and automated testing process for estrogen receptor/progesterone receptor (ER/PR) tests to minimize testing errors. Objectives.—To test the (1) variability in ER/PR negativity among hospitals and (2) association between Specimen Handling conditions and ER/PR negativity. Design.—Retrospective study of women who had breast cancer surgery at 7 Intermountain hospitals and ER/PR tests ordered between 1997 and 2003. Data were extracted from cancer registry. Frequency of ER/PR negativity was calculated for each surgery day and compared among hospitals and between 2 groups: regular (Specimens obtained Sunday through Thursday, more likely to be tested within 24 hours of surgery) and prolonged (Specimens obtained on Friday and Saturday, more likely to be tested more than 24 hours after surgery) Specimen Handling conditions. Results.—Five thousand seventy-seven women were tested for ER/PR. The frequency of ER and PR negativity was 20.9% and 27.9%, respectively. It increased with each day of the week for both ER (P = .03) and PR (P = .059) and tended to be higher for prolonged Specimens for ER (23.6% versus 20.4%; P = .03) and for PR (30.1% versus 27.4%; P = .11) compared with regular Specimens. After controlling for age and tumor size, both ER (P = .02) and PR (P = .02) negativity was significantly different among the hospitals and was associated with prolonged Specimens for ER (P = .04) but not for PR (P = .09). Conclusions.—Estrogen receptor and PR negativity remained highly variable among hospitals despite use of a single laboratory and tended to be significantly associated with prolonged Specimen Handling. More studies are needed to confirm these findings.
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Variable Specimen Handling Affects Hormone Receptor Test Results in Women With Breast Cancer: A Large Multihospital Retrospective Study
Archives of pathology & laboratory medicine, 2010Co-Authors: Flory L. Nkoy, Braden D. Rowley, M. Elizabeth H. Hammond, William Rees, Tom Belnap, Steve Catmull, William SauseAbstract:Abstract Context.—Intermountain Healthcare hospitals use a single, standardized laboratory and automated testing process for estrogen receptor/progesterone receptor (ER/PR) tests to minimize testin...
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Impact of Recording of Pre-Analytical Specimen Handling Conditions for ER and PR Testing in Women with Breast Cancer.
Poster Session Abstracts, 2009Co-Authors: Elizabeth H. Hammond, J. Fetzer, T. Belnap, Braden D. Rowley, C. Hall, Flory L. NkoyAbstract:Background : Hormone receptor testing is important in the management of women with breast cancer. We previously reported potential adverse effects of variable Specimen and prolonged Specimen Handling conditions on ER (estrogen receptor) test results (2005 SABCS, abstract#5107). Objective : To compare prevalence of ER and PR (progesterone receptor) negative test results following standardization of pre-analytical Specimen Handling conditions at Intermountain facilities. Methods : Prospective, quasi-experimental study design of 6 Intermountain facilities. Facilities were separated into 2 categories: experimental (2 facilities) and control (4 facilities) groups. Pre-analytical Specimen Handling conditions (including recording of time to fixative and duration of fixation in neutral buffered formalin) were standardized at experimental facilities but not at control facilities. Standardization consisted of educating operating and grossing room staff about appropriate Specimen Handling and the value of recording time to fixation and fixative duration as a way to improve pre-analytic standardization. OR staff was called in any cases where times were not recorded. Study population includes women undergoing breast cancer surgery and who were tested for ER/PR status between January 2008 and January 2009. Specimen Handling conditions and ER/PR test results were collected manually. Covariates were retrieved from cancer registry and included age, grade, positive lymph nodes, Specimen type, and tumor stage. Multivariate logistic regression was used to compare prevalence of ER and PR negativity between experimental and control facilities after controlling for covariates. Results : 1054 women with breast cancer were tested for ER/PR status during the study period. The average age was 60.2 years (59.2 years for control cases and 61.1 years for the experimental group). The overall prevalence of ER and PR negative tests was respectively 18.5% and 27.3%. Average time to fixative at experimental facilities was 18.4 minutes (SE=3.1; 95% CI, 12.2-25.6) and average time in fixative was 18.0 hours (SE=0.4; 95% CI, 17.2-18.8). Compared to experimental facilities, both the prevalence of ER and PR negativity was higher (16.9% vs 19.7%) and (23.9% vs 30.0%) at control facilities. After controlling for covariates there was no difference in prevalence of ER negativity (p=0.13) between the two groups. However, the prevalence of PR negativity remains significantly higher (p Conclusions: The prevalence of ER and PR negative results was lower following staff education and recording of pre-analytical Specimen Handling conditions. Our data suggest that staff education and recording of pre-analytical Specimen Handling conditions has the potential to optimize hormone receptor test results. It also shows the feasibility of fixing tissue routinely after less than an hour interval between time of breast cancer tissue removal and fixation and underscores the value of standardization of pre-analytic Handling as a method to improve ER and PR testing on breast cancer Specimens. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4154.
Bas L.a.m. Weusten - One of the best experts on this subject based on the ideXlab platform.
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optimizing histopathologic evaluation of emr Specimens of barrett s esophagus related neoplasia a randomized study of 3 Specimen Handling methods
Gastrointestinal Endoscopy, 2019Co-Authors: Anouk Overwater, Kim Van Der Meulen, Hannah T. Künzli, Erik J. Schoon, Jacques J. Bergman, Kees A. Seldenrijk, Mihaela G Raicu, Bas L.a.m. WeustenAbstract:Background and Aims Endoscopic resection is the cornerstone of treatment of Barrett’s esophagus (BE)-related neoplasia. However, accurate histopathologic evaluation of endoscopic resection Specimens can be challenging, and the preferred Specimen Handling method remains unknown. Therefore, the aim of our study was to compare 3 different Specimen Handling methods for assessment of all clinically relevant histopathologic parameters and time required for Specimen Handling. Methods In this multicenter, randomized study EMR Specimens of BE-related neoplasia with no suspicion of submucosal invasion during endoscopy were randomized to 3 Specimen Handling methods: pinning on paraffin using needles, direct fixation in formalin without prior tissue Handling, and the cassette technique (small box for enclosing Specimens). The histopathologic evaluation scores were assessed by 2 dedicated GI pathologists blinded to the Handling method. Results Of the 126 randomized EMR Specimens, 45 were assigned to pinning on paraffin, 41 to direct fixation in formalin, and 40 to the cassette technique. The percentages of Specimens with overall optimal histopathologic evaluation scores were similar for the pinning method (98%; 95% confidence interval [CI], 88.0-99.9) and for no Handling (90%; 95% CI, 76.9-97.3) but were significantly lower (64%; 95% CI, 47.2-78.8) for the cassette technique (P Conclusions Both pinning on paraffin and direct fixation in formalin resulted in optimal histopathologic evaluation scores in a high proportion of Specimens, whereas the cassette technique performs significantly worse, and its use in clinical daily practice should be discouraged. Given the significantly shorter Handling time, direct fixation in formalin appears to be the preferred method over pinning on paraffin. However, the latter needs to be confirmed in larger studies with inclusion of all EMR Specimens. (Clinical trial registration number: ISRCTN50525266.)
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Optimizing histopathologic evaluation of EMR Specimens of Barrett’s esophagus–related neoplasia: a randomized study of 3 Specimen Handling methods
Gastrointestinal endoscopy, 2019Co-Authors: Anouk Overwater, Kim Van Der Meulen, Hannah T. Künzli, Erik J. Schoon, Jacques J. Bergman, G. Mihaela Raicu, Kees A. Seldenrijk, Bas L.a.m. WeustenAbstract:Background and Aims Endoscopic resection is the cornerstone of treatment of Barrett’s esophagus (BE)-related neoplasia. However, accurate histopathologic evaluation of endoscopic resection Specimens can be challenging, and the preferred Specimen Handling method remains unknown. Therefore, the aim of our study was to compare 3 different Specimen Handling methods for assessment of all clinically relevant histopathologic parameters and time required for Specimen Handling. Methods In this multicenter, randomized study EMR Specimens of BE-related neoplasia with no suspicion of submucosal invasion during endoscopy were randomized to 3 Specimen Handling methods: pinning on paraffin using needles, direct fixation in formalin without prior tissue Handling, and the cassette technique (small box for enclosing Specimens). The histopathologic evaluation scores were assessed by 2 dedicated GI pathologists blinded to the Handling method. Results Of the 126 randomized EMR Specimens, 45 were assigned to pinning on paraffin, 41 to direct fixation in formalin, and 40 to the cassette technique. The percentages of Specimens with overall optimal histopathologic evaluation scores were similar for the pinning method (98%; 95% confidence interval [CI], 88.0-99.9) and for no Handling (90%; 95% CI, 76.9-97.3) but were significantly lower (64%; 95% CI, 47.2-78.8) for the cassette technique (P Conclusions Both pinning on paraffin and direct fixation in formalin resulted in optimal histopathologic evaluation scores in a high proportion of Specimens, whereas the cassette technique performs significantly worse, and its use in clinical daily practice should be discouraged. Given the significantly shorter Handling time, direct fixation in formalin appears to be the preferred method over pinning on paraffin. However, the latter needs to be confirmed in larger studies with inclusion of all EMR Specimens. (Clinical trial registration number: ISRCTN50525266.)
C.s. Evans - One of the best experts on this subject based on the ideXlab platform.
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Impact of Specimen Handling and storage on detection of hepatitis C virus RNA.
Transfusion, 1992Co-Authors: M.p. Busch, J Wilber, P. Johnson, Leslie H. Tobler, C.s. EvansAbstract:Direct detection of hepatitis C virus (HCV) RNA in serum or plasma is useful for validating the performance of anti-HCV assays and for the discrimination of persons with persistent HCV infections from those with resolved infections. Quantitation of HCV RNA may also be useful for disease prognosis and therapeutic monitoring. Previous studies have reported detection of HCV RNA in 50 to 70 percent of blood donors who were positive on anti-HCV supplemental tests. There is concern that Specimen processing and storage conditions might influence the stability, and hence the detectability, of HCV RNA. To address this concern, the rate of detection of HCV RNA by the polymerase chain reaction (PCR) using donor pilot tube sera (PTS) previously subjected to routine donor screening and supplemental testing was compared with HCV PCR results obtained with fresh-frozen plasma (FFP) derived from the same donations. All 16 anti-HCV supplemental test-positive donations evaluated were HCV RNA positive with FFP, whereas only 10 (62.5%) were positive with PTS (p = 0.024). None of 11 FFP or PTS samples from HCV enzyme immunoassay-reactive donations not confirmed by supplemental anti-HCV assays tested positive for HCV RNA. Direct comparison of sample type (serum vs. plasma) and various storage conditions using Specimens from two seropositive donors showed that room-temperature storage results in marked reduction in HCV RNA signal, while replicate freezing and thawing caused a moderate reduction. These data indicate that well-controlled sample processing and storage conditions are critical to the sensitive and potentially quantitative analysis of HCV RNA.