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  • Archives of Pathology and Laboratory Medicine  (4)
  • 1
    Online Resource
    Online Resource
    Screening for Down Syndrome in the United States: Results of Surveys in 2011 and 2012
    Archives of Pathology and Laboratory Medicine ; 2013
    In:  Archives of Pathology & Laboratory Medicine Vol. 137, No. 7 ( 2013-07-01), p. 921-926
    Details
    In: Archives of Pathology & Laboratory Medicine, Archives of Pathology and Laboratory Medicine, Vol. 137, No. 7 ( 2013-07-01), p. 921-926
    Abstract: Context.—Participants in a College of American Pathologists external proficiency testing program for first and second trimester Down syndrome screening. Objectives.—To determine the number of women screened for Down syndrome in the United States, along with the type of test received and to compare those results to earlier surveys in 1988 and 1992. Design.—Questionnaires regarding the type and number of Down syndrome tests performed per month were completed by participants in early 2011 and again in early 2012. Results.—After accounting for some of the missing responses, data from up to 131 laboratories indicated that 67% (2 764 020 of 4 130 000) to 72% (2012: 2 963 592 of 4 130 000) of US pregnancies received prenatal screening for Down syndrome. Second trimester tests were most common (2012: 60%; 1 770 024 of 2 963 592), followed by integrated (2012: 21%; 627 876 of 2 963 592), and first trimester (2012: 19%; 565 692 of 2 963 592). The 6 largest laboratories tested 61% of screened pregnancies and offered the widest array of tests, while the smallest 32 tested 1% and almost always offered only second trimester tests. Conclusions.—The current population estimate of 72% pregnancies screened annually is higher than estimates from 1988 (25%) and 1992 (50%). Available testing choices are also more varied, and all testing methods perform better than those methods available 10 years ago. Clinicians should ensure that women are offered tests that follow recommended best-practice testing protocols, and screening laboratories should assess whether patient needs are being met.
    Type of Medium: Online Resource
    ISSN: 1543-2165 , 0003-9985
    URL: Article
    DOI: 10.5858/arpa.2012-0319-CP
    RVK:
    XA 10000
    RVK:
    XA 29700
    Language: English
    Publisher: Archives of Pathology and Laboratory Medicine
    Publication Date: 2013
    detail.hit.zdb_id: 2028916-9
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  • 2
    Online Resource
    Online Resource
    A Comparison of Human Chorionic Gonadotropin– Related Components in Fresh Frozen Serum With the Proficiency Testing Material Used by the College of American Pathologists
    Archives of Pathology and Laboratory Medicine ; 2005
    In:  Archives of Pathology & Laboratory Medicine Vol. 129, No. 3 ( 2005-03-01), p. 328-330
    Details
    In: Archives of Pathology & Laboratory Medicine, Archives of Pathology and Laboratory Medicine, Vol. 129, No. 3 ( 2005-03-01), p. 328-330
    Abstract: Context.—As part of a College of American Pathologists (CAP) proficiency testing survey, a comparison is made between human chorionic gonadotropin (hCG) results from an actual patient pool and a similarly targeted artificial sample. The goal is to gain insight into the possible source(s) of bias attributable to the proficiency testing material (PTM) with a view toward creating more appropriate survey materials. Objective.—To compare hCG and related variants in a pool of fresh frozen sera (FFS) with that found in PTM. Design.—The 2003 CAP K/KN-A Survey included a FFS specimen along with admixtures of PTM. The FFS (K-02) and 1 PTM admixture (K-01) had similar mean hCG values. Five hCG-related analytes were measured on these 2 samples by a reference laboratory. Participants.—Approximately 1800 clinical laboratories and diagnostic test kit manufacturers participated in the K/ KN-A Survey. Main Outcome Measures.—Method imprecision (coefficient of variation) and method bias (relative difference between peer group mean and all-method median) were computed for the 2 samples. Differences were evaluated with respect to hCG-related analytes levels. Results.—All-method hCG results were 12.9 mIU/mL (12.9 IU/L) for the PTM material and 21.6 mIU/mL (21.6 IU/L) for the FFS material. Method biases for 14 manufacturers were greater for PTM than for FFS (−40% to +35% and −16% to +23%). Twelve of 14 methods had higher coefficients of variation on PTM. Total hCG and free β hCG measurements by the reference laboratory were 14.1 mIU/ mL (14.1 IU/L) for the PTM material and 18.5 mIU/mL (18.5 U/L) for the FFS material (FFS), and 2.4 (PTM) and 0.7 (FFS) mIU/mL (2.4 and 0.7 IU/L), respectively. On a molar basis, free β represented 17% and 4% of the total hCG, respectively. Levels of hyperglycosylated hCG, nicked hCG, and β core fragment were not measurable in either sample. Conclusions.—It is unlikely that the hCG added to the PTM is the source of the increased bias and variability. The main difference is a 3-fold increase in free β found in the PTM, but methods previously found to strongly react with free β were not systematically elevated. The biases between manufacturers found for the FFS specimen are likely attributable to calibration differences.
    Type of Medium: Online Resource
    ISSN: 1543-2165 , 0003-9985
    URL: Article
    DOI: 10.5858/2005-129-328-ACOHCG
    RVK:
    XA 10000
    RVK:
    XA 29700
    Language: English
    Publisher: Archives of Pathology and Laboratory Medicine
    Publication Date: 2005
    detail.hit.zdb_id: 2028916-9
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  • 3
    Online Resource
    Online Resource
    Comparison of Fresh Frozen Serum to Proficiency Testing Material in College of American Pathologists Surveys: α-Fetoprotein, Carcinoembryonic Antigen, Human Chorionic Gonadotropin, and Prostate-Specific Antigen
    Archives of Pathology and Laboratory Medicine ; 2005
    In:  Archives of Pathology & Laboratory Medicine Vol. 129, No. 3 ( 2005-03-01), p. 331-337
    Details
    In: Archives of Pathology & Laboratory Medicine, Archives of Pathology and Laboratory Medicine, Vol. 129, No. 3 ( 2005-03-01), p. 331-337
    Abstract: Context.—Most proficiency testing materials (PTM) contain an artificial matrix that may cause immunoassays to perform differently with this material than with clinical samples. We hypothesized that matrix effects would be reduced by using fresh frozen serum (FFS). Objective.—To compare the performance of an FFS pool to standard PTM for measurement of α-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin (hCG), and prostate-specific antigen (PSA). Design.—One FFS specimen and 4 different admixtures of PTM were distributed in the 2003 College of American Pathologists K/KN-A (for α-fetoprotein, carcinoembryonic antigen, hCG, and total and free PSA) and C-C (hCG only) Surveys. Participants.—The number of laboratories that participated in the surveys varied from a low of 288 (free PSA, K/KN-A Survey) to a high of 2659 (hCG, C-C Survey). Main Outcome Measures.—Method imprecision and method bias were compared between the FFS specimen and the standard PTM specimen with the closest value. Method imprecision was determined by calculating the coefficients of variation for each method and for all methods combined. Bias was defined as the proportional difference between peer-group mean and the median of all method means. Results.—The FFS specimen gave significantly higher imprecision than PTM for the analytes α-fetoprotein, carcinoembryonic antigen, total PSA, and free PSA. For hCG, no substantial imprecision differences were observed in both surveys. Bias was significantly greater for the α-fetoprotein, carcinoembryonic antigen, and total PSA assays and significantly lower for the hCG and free PSA assays when comparing the FFS with the PTM. Conclusions.—Fresh frozen serum did not provide consistently lower imprecision or bias than standard PTM in a survey of commonly ordered tumor markers.
    Type of Medium: Online Resource
    ISSN: 1543-2165 , 0003-9985
    URL: Article
    DOI: 10.5858/2005-129-331-COFFST
    RVK:
    XA 10000
    RVK:
    XA 29700
    Language: English
    Publisher: Archives of Pathology and Laboratory Medicine
    Publication Date: 2005
    detail.hit.zdb_id: 2028916-9
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  • 4
    Online Resource
    Online Resource
    An Evaluation of Analytic Goals for Assays of Drugs
    Archives of Pathology and Laboratory Medicine ; 2001
    In:  Archives of Pathology & Laboratory Medicine Vol. 125, No. 6 ( 2001-06-01), p. 729-735
    Details
    In: Archives of Pathology & Laboratory Medicine, Archives of Pathology and Laboratory Medicine, Vol. 125, No. 6 ( 2001-06-01), p. 729-735
    Abstract: Objective.—To determine if the levels of imprecision of the commonly used analytic methods for drug measurements are suitable for long-term therapeutic drug monitoring. Design.—In 1996, 4 identical lyophilized samples (2 in the first mailing and 2 in the second mailing 4 months later) were sent to laboratories participating in a nationwide proficiency testing program. Similarly, in 1999, replicates from a liquid pool of spiked sera were mailed 3 times, 4 months apart, to participating laboratories. For each of 11 drugs regulated under the Clinical Laboratory Improvement Amendments of 1988 and 1 metabolite, the total variance for each method was partitioned into within- and between-laboratory components. The total within-laboratory and the total survey coefficients of variation (CVs) for each method were then compared with the “acceptable” precision criteria of Glick, Burnett, and Fraser for each drug. Setting.—The first 2 mailings of the College of American Pathologists Therapeutic Drug Monitoring surveys for 1996, sets Z and ZM, and the 3 mailings of 1999, sets ZM, Z, and Z2. Main Outcome Measures.—For each drug studied, the CV of each method was compared with the various imprecision criteria, and if greater than any of the criteria, the method was then tabulated as not meeting that specific criterion. Participants.—The approximately 5000 participants of the survey. Results.—The number of methods deemed as not having acceptable total long-term within-laboratory precision by the various criteria ranged from 35% to 88% in 1996 and from 22% to 77% in 1999. Conclusion.—The number of failures possibly indicates that many of the reagent assays being utilized are not precise enough for long-term therapeutic drug monitoring of chronically administered drugs or that the published criteria used to evaluate the data in this study are too stringent.
    Type of Medium: Online Resource
    ISSN: 1543-2165 , 0003-9985
    URL: Article
    DOI: 10.5858/2001-125-0729-AEOAGF
    RVK:
    XA 10000
    RVK:
    XA 29700
    Language: English
    Publisher: Archives of Pathology and Laboratory Medicine
    Publication Date: 2001
    detail.hit.zdb_id: 2028916-9
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