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  1. Article ; Online: Arc of the Milky Way.

    Grenache, David G

    Clinical chemistry

    2020  Volume 66, Issue 3, Page(s) 501

    Language English
    Publishing date 2020-03-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvz030
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Progress in understanding the use of human chorionic gonadotropin as a tumor marker.

    Grenache, David G

    Clinical chemistry and laboratory medicine

    2020  Volume 58, Issue 3, Page(s) 323–325

    MeSH term(s) Biomarkers, Tumor/blood ; Chorionic Gonadotropin/blood ; Humans ; Limit of Detection
    Chemical Substances Biomarkers, Tumor ; Chorionic Gonadotropin
    Language English
    Publishing date 2020-01-19
    Publishing country Germany
    Document type Editorial
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2019-1288
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Current Practices When Reporting Quantitative Human Chorionic Gonadotropin Test Results.

    Grenache, David G

    The journal of applied laboratory medicine

    2020  Volume 5, Issue 5, Page(s) 850–857

    Abstract: Background: Quantitative human chorionic gonadotropin (hCG) tests are commonly used to determine a woman's pregnancy status. Discrete results are evaluated and/or interpreted against a reference interval or cutoff. Reporting practices across ... ...

    Abstract Background: Quantitative human chorionic gonadotropin (hCG) tests are commonly used to determine a woman's pregnancy status. Discrete results are evaluated and/or interpreted against a reference interval or cutoff. Reporting practices across laboratories have not been investigated.
    Methods: A voluntary questionnaire was distributed to 6433 laboratories participating in a general chemistry proficiency testing survey.
    Results: Responses were received from 3568 (55%) laboratories. Overall, 31% used a single reference cutoff, with 42% and 14% using values of 5.0 and 25.0 IU/L, respectively. In total, 68% of laboratories provided result interpretations, most frequently "negative" and "positive." Reference intervals based on chronological age were offered by 9% of laboratories; 60% reported gestational age-based intervals. In addition, 25% provided male-specific reference intervals, with 2.0 IU/L being the most commonly used single-point cutoff. Only 12% of laboratories offered a separate, orderable test for hCG as a tumor marker, with 5.0 IU/L as the most frequently used reference threshold. Nearly half of laboratories used assay product insert data as the reference interval source.
    Conclusions: There is wide variation when reporting quantitative hCG results. Despite a well-established reference limit of <5.0 IU/L for nonpregnant women, fewer than half of laboratories used this cutoff. The reporting of gestational age-based reference intervals is more common than those based on chronological age despite greater clinical utility for the latter. Data-driven guidelines for reporting quantitative hCG test results could deliver more consistent result interpretation.
    MeSH term(s) Chorionic Gonadotropin ; Female ; Humans ; Male ; Pregnancy ; Pregnancy Tests ; Reference Values
    Chemical Substances Chorionic Gonadotropin
    Language English
    Publishing date 2020-08-03
    Publishing country England
    Document type Journal Article
    ISSN 2576-9456
    ISSN 2576-9456
    DOI 10.1093/jalm/jfaa082
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Six Reasons You Should Attend the AACC Annual Scientific Meeting and Clinical Lab Expo.

    Grenache, David G / Straseski, Joely A

    The journal of applied laboratory medicine

    2021  Volume 3, Issue 1, Page(s) 146–147

    Language English
    Publishing date 2021-02-25
    Publishing country England
    Document type Journal Article
    ISSN 2576-9456
    ISSN 2576-9456
    DOI 10.1373/jalm.2018.026880
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Performance Evaluation of a Serum S-100B ELISA for Use with Cerebrospinal Fluid.

    Erickson, J Alan / Grenache, David G

    The journal of applied laboratory medicine

    2021  Volume 2, Issue 5, Page(s) 811–813

    Language English
    Publishing date 2021-01-26
    Publishing country England
    Document type Journal Article
    ISSN 2576-9456
    ISSN 2576-9456
    DOI 10.1373/jalm.2017.024752
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Reference Intervals for Intestinal Disaccharidase Activities Determined from a Non-Reference Population.

    Hackenmueller, Sarah A / Grenache, David G

    The journal of applied laboratory medicine

    2021  Volume 1, Issue 2, Page(s) 172–180

    Abstract: ... determined to be 10, 100, 9, and 25 U/g protein, respectively. Applying these cutoffs to the data set, 61 ... should increase from 5 to 9 U/g protein, and the lactase cutoff should decrease from 15 to 10 U/g protein. ...

    Abstract Background: Cutoff activities for diagnosing disaccharidase deficiencies are historical and are difficult to verify from a reference population. The objectives of this study were to validate the utility of historical disaccharidase cutoffs using data from clinical samples and to evaluate the demographics of individuals for whom intestinal disaccharidase testing was performed.
    Methods: Results from 14,827 disaccharidase test samples were extracted from the laboratory information system. Data were analyzed by the Hoffman method to calculate a reference interval for each enzyme, and the lower limits were compared to historical cutoffs. The observed frequencies of disaccharidase deficiencies were determined using historic and calculated cutoffs.
    Results: The median patient age of the entire data set was 13 years (range <1-88 years), and 45% were male. The cutoffs for lactase, maltase, palatinase, and sucrase were determined to be 10, 100, 9, and 25 U/g protein, respectively. Applying these cutoffs to the data set, 61% had no enzyme deficiencies, 35% were lactase deficient, 11% were maltase deficient, 13% were palatinase deficient, and 13% were sucrase deficient. Pandisaccharidase deficiency was present in 8%.
    Conclusions: Disaccharidase testing is most commonly performed in patients <18 years. Lactase deficiency is the most frequently observed single-disaccharidase deficiency. The historical cutoffs for maltase and sucrase were validated. To align with calculated reference intervals, the palatinase cutoff should increase from 5 to 9 U/g protein, and the lactase cutoff should decrease from 15 to 10 U/g protein.
    Language English
    Publishing date 2021-02-25
    Publishing country England
    Document type Journal Article
    ISSN 2576-9456
    ISSN 2576-9456
    DOI 10.1373/jalm.2016.020388
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Commentary.

    Grenache, David G

    Clinical chemistry

    2017  Volume 63, Issue 7, Page(s) 1202

    MeSH term(s) Ascites ; Cholecystectomy, Laparoscopic ; Humans ; Male
    Language English
    Publishing date 2017-06-26
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1373/clinchem.2016.268474
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Development of an Automated Enzymatic Method to Quantify Pyruvate Kinase in Red Blood Cells.

    Lu, Jun / Grenache, David G

    The journal of applied laboratory medicine

    2020  Volume 5, Issue 1, Page(s) 54–61

    Abstract: ... was 4.0% and 5.6% at 14.0 and 8.1 U/g Hb, respectively. The limit of blank was 0.0, and the limit ... were all <10% when compared with t0. The current PK reference interval of 4.6 to 11.2 U/g Hb was ...

    Abstract Background: Pyruvate kinase (PK) deficiency is the most common cause of nonspherocytic hemolytic anemia owing to defective glycolysis. This study developed and validated an automated method to measure PK activity in red blood cells (RBCs).
    Methods: PK catalyzes the reaction of phosphoenolpyruvate with ADP to form pyruvate and ATP. The pyruvate is reduced in the presence of lactate dehydrogenase and NADH to produce lactate and NAD+. The rate of absorbance decrease at 340 nm is proportional to PK activity. PK and hemoglobin (Hb) measurements were performed on a Roche cobas c501 analyzer. After establishing a k-factor, accuracy, linearity, imprecision, sensitivity, and stability were validated and the reference interval was verified.
    Results: The k-factor was -9477. Accuracy was evaluated by method comparison (n = 56). Linear regression yielded y = 1.0x - 0.57, and R2 of 0.93. Linearity was determined by combining a high sample with hemolyzing solution in 6 different ratios. Linear regression analysis yielded y = 1.02x - 2.68, and R2 of 1.0. The assay was linear to 87 U/dL. Precision was evaluated by testing hemolysates in 3 replicates/day for 10 days. Within-run imprecision was 1.9% and 2.5% and total imprecision was 4.0% and 5.6% at 14.0 and 8.1 U/g Hb, respectively. The limit of blank was 0.0, and the limit of detection was 1.0 U/dL. Stability was determined in 4 sample types at 3 different temperatures; the changes were all <10% when compared with t0. The current PK reference interval of 4.6 to 11.2 U/g Hb was verified.
    Conclusions: This automated assay for quantifying PK in RBCs has acceptable performance characteristics and is fit for intended use.
    MeSH term(s) Anemia, Hemolytic/diagnosis ; Anemia, Hemolytic/etiology ; Anemia, Hemolytic, Congenital Nonspherocytic/blood ; Anemia, Hemolytic, Congenital Nonspherocytic/complications ; Automation, Laboratory/methods ; Chemistry Techniques, Analytical ; Erythrocytes/enzymology ; Hemoglobins/analysis ; Humans ; Limit of Detection ; Pyruvate Kinase/analysis ; Pyruvate Kinase/blood ; Pyruvate Kinase/deficiency ; Pyruvate Metabolism, Inborn Errors/blood ; Pyruvate Metabolism, Inborn Errors/complications ; Reproducibility of Results
    Chemical Substances Hemoglobins ; Pyruvate Kinase (EC 2.7.1.40)
    Language English
    Publishing date 2020-05-20
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2576-9456
    ISSN 2576-9456
    DOI 10.1373/jalm.2019.029579
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Variable accuracy of home pregnancy tests: truth in advertising?

    Grenache, David G

    Clinical chemistry and laboratory medicine

    2015  Volume 53, Issue 3, Page(s) 339–341

    MeSH term(s) Advertising as Topic/standards ; Chorionic Gonadotropin/urine ; Female ; Humans ; Limit of Detection ; Pregnancy ; Pregnancy Tests/standards
    Chemical Substances Chorionic Gonadotropin
    Language English
    Publishing date 2015-02
    Publishing country Germany
    Document type Editorial
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2014-1033
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: Genotype-Phenotype Correlations of Glucose-6-Phosphate-Deficient Variants Throughout an Activity Distribution.

    Powers, Jennifer L / Best, D Hunter / Grenache, David G

    The journal of applied laboratory medicine

    2021  Volume 2, Issue 6, Page(s) 841–850

    Abstract: ... An activity cutoff of <7.85 U/g hemoglobin (Hb) was 100% sensitive and 94% specific for identifying a G6PD ... deficient male, and a cutoff of <8.95 U/g Hb was 90% sensitive and 82% specific for a deficient female ...

    Abstract Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an X-linked disorder that may manifest as neonatal jaundice or acute hemolytic anemia. Quantitative assessment of G6PD activity in erythrocytes is required to definitively diagnose a deficiency. Most males and homozygous females have low enzyme activities, whereas heterozygous females may have a range of activities. We sought to examine G6PD genotype-phenotype associations to identify an activity cutoff above which G6PD deficiency is unlikely.
    Methods: Ninety-five residual samples were randomly selected to represent the various regions of a G6PD activity distribution. DNA was isolated from the leukocyte fraction and sequenced using the Sanger method. ROC curves were used to establish cutoffs.
    Results: Thirteen variant alleles were identified, including 1 not previously reported. In the very deficient activity range, we found males and homozygous females of both class II and III variants. In the deficient category, we found predominantly class III males and heterozygous females. The presumed deficient category contained class III and IV variants and nonvariants. An activity cutoff of <7.85 U/g hemoglobin (Hb) was 100% sensitive and 94% specific for identifying a G6PD-deficient male, and a cutoff of <8.95 U/g Hb was 90% sensitive and 82% specific for a deficient female.
    Conclusions: The observed activity groupings were not because of a particular variant class. Cutoffs to identify the presence of a deficiency variant for males and females may be useful when trying to decide whether to recommend genetic analysis.
    Language English
    Publishing date 2021-01-26
    Publishing country England
    Document type Journal Article
    ISSN 2576-9456
    ISSN 2576-9456
    DOI 10.1373/jalm.2017.024935
    Database MEDical Literature Analysis and Retrieval System OnLINE

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