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  1. Article ; Online: Remote support of an external quality assessment program in 10 laboratories in Bhutan, Uganda, and Malawi: Pathologists Overseas experience between 2009 and 2017.

    Harb, Roa / Tuggey, Robert / Ladenson, Jack H / Amukele, Timothy

    American journal of clinical pathology

    2024  

    Abstract: Objectives: This article describes Pathologists Overseas (PO) experience supporting external quality assessment (EQA) programs in 10 clinical laboratories across 3 countries between 2009 and 2017.: Methods: Laboratories were enrolled in the condensed ...

    Abstract Objectives: This article describes Pathologists Overseas (PO) experience supporting external quality assessment (EQA) programs in 10 clinical laboratories across 3 countries between 2009 and 2017.
    Methods: Laboratories were enrolled in the condensed chemical pathology EQA program provided by the Royal College of Pathologists of Australasia Quality Assurance Program. Participants were given an initial 2- to 4-day in-person training, followed by 1 year of active feedback on performance via emails or phone calls by a PO volunteer.
    Results: There were 2 performance metrics: percentage of reported results as a measure of compliance and percentage of acceptable reported results as a measure of accuracy. Laboratories demonstrated high compliance with result reporting, with medians of 69.9%, 71.7%, and 81.3% before, during, and after feedback, respectively. Concomitant medians for the percentage of acceptable reported results were 41.2%, 57.3%, and 53.5%, respectively. Six laboratories had low performance in terms of accuracy at baseline (<60%). Active feedback improved the percentage of acceptable reported results for these lower-performing laboratories.
    Conclusions: External quality assessment programs can be successfully adopted long term by laboratories in low-resource settings. Active feedback requires significant time and effort but could be especially beneficial for laboratories with poor baseline performance.
    Language English
    Publishing date 2024-02-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 2944-0
    ISSN 1943-7722 ; 0002-9173
    ISSN (online) 1943-7722
    ISSN 0002-9173
    DOI 10.1093/ajcp/aqae009
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  2. Article ; Online: Antibody response to SARS-CoV-2 booster vaccines.

    Loving, Hanna S / Sacks, David B / Harb, Roa

    Clinical biochemistry

    2022  Volume 107, Page(s) 80–82

    MeSH term(s) Antibodies, Viral ; Antibody Formation ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; SARS-CoV-2
    Chemical Substances Antibodies, Viral ; COVID-19 Vaccines
    Language English
    Publishing date 2022-06-15
    Publishing country United States
    Document type Letter
    ZDB-ID 390372-2
    ISSN 1873-2933 ; 0009-9120
    ISSN (online) 1873-2933
    ISSN 0009-9120
    DOI 10.1016/j.clinbiochem.2022.06.004
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  3. Article: Interpreting Anion Gap Values in Adult and Pediatric Patients: Examining the Reference Interval.

    Ayala-Lopez, Nadia / Harb, Roa

    The journal of applied laboratory medicine

    2020  Volume 5, Issue 1, Page(s) 126–135

    Abstract: Background: The anion gap is primarily used in the diagnosis of acid-base disorders. We conducted a study to determine the anion gap reference interval in our patient population, investigated the workup of abnormal vs normal anion gaps, and examined the ...

    Abstract Background: The anion gap is primarily used in the diagnosis of acid-base disorders. We conducted a study to determine the anion gap reference interval in our patient population, investigated the workup of abnormal vs normal anion gaps, and examined the anion gap variation upon repeated testing.
    Methods: A retrospective review was performed on 17137 adult and pediatric patients who presented to Yale-New Haven Hospital outpatient clinics, emergency department, or intensive care units between 2012 and 2017.
    Results: We derived a new reference interval of 7 to 18 mmol/L with a median of 13 mmol/L in healthy adults with no significant differences owing to partitioning by sex or age. Based on the new reference interval, 5%, 23%, and 18% of healthy, emergency department, and intensive care unit adult patients, respectively, were misclassified as having high values with the previous interval of 6 to 16 mmol/L. However, there were no significant differences in the number of tests ordered in patients with anion gaps above and below the upper limit of the previous reference interval. The majority of increased anion gaps that were repeated normalized by 12 h. In a subgroup of healthy adult patients with annual testing, the median percent change in each patient's anion gap from 2015 to 2016 was approximately 13%.
    Conclusions: The anion gap should be used with an appropriate reference interval to avoid misclassification. There may be a moderate degree of individuality that argues for comparing the anion gap with its baseline value in the same patient pending further studies that formally derive its biological variation.
    MeSH term(s) Acid-Base Equilibrium/physiology ; Acid-Base Imbalance/blood ; Acid-Base Imbalance/diagnosis ; Adult ; Age Factors ; Analysis of Variance ; Biological Variation, Population ; Child ; Female ; Humans ; Male ; Reference Values ; Retrospective Studies
    Language English
    Publishing date 2020-05-20
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ISSN 2576-9456
    ISSN 2576-9456
    DOI 10.1373/jalm.2019.029496
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  4. Article ; Online: Evaluation of Three Commercial Automated Assays for the Detection of Anti-SARS-CoV-2 Antibodies.

    Harb, Roa / Remaley, Alan T / Sacks, David B

    Clinical chemistry

    2020  Volume 66, Issue 10, Page(s) 1351–1353

    MeSH term(s) Betacoronavirus ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques ; Coronavirus Infections/diagnosis ; Humans ; Pandemics ; Pneumonia, Viral ; SARS-CoV-2 ; Severe Acute Respiratory Syndrome
    Keywords covid19
    Language English
    Publishing date 2020-08-06
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvaa193
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  5. Article: Pathologists Overseas: A volunteer-based model for building sustainable, high-quality pathology and laboratory medicine services in low- and middle-income countries.

    Glynn, Emily H / Nelson, Ann Marie / Tesfazghi, Merih / Harb, Roa / Amukele, Timothy

    Frontiers in medicine

    2022  Volume 9, Page(s) 977840

    Abstract: For thirty years Pathologists Overseas (PO) has worked in low- and middle-income countries (LMICs) to provide affordable, sustainable, and high-quality pathology and laboratory medicine (PALM) services through strategic partnerships and the efforts of ... ...

    Abstract For thirty years Pathologists Overseas (PO) has worked in low- and middle-income countries (LMICs) to provide affordable, sustainable, and high-quality pathology and laboratory medicine (PALM) services through strategic partnerships and the efforts of our large volunteer network. We address low quality diagnostic services by targeting the 3 pillars of PALM quality: human resources, systems, and quality and accreditation. To improve human resource capacity, PO and our partnering organizations provide virtual continuing education to pathologists and laboratory professionals in these countries. To improve systems, we provide laboratory information system installation and implementation support. Lastly, to improve quality and help laboratories progress toward accreditation, we support an external quality assurance program for laboratories in LMICs. As a relatively small organization, PO demonstrates that a network of dedicated volunteers, in partnership with corporations and professional organizations, can initiate sustainable change in the quality of PALM services in LMICs by focusing efforts on the core components of laboratory quality.
    Language English
    Publishing date 2022-08-30
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2022.977840
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  6. Article ; Online: Procalcitonin Correlates With but Is Not Superior to Other Diagnostic Markers of Bacterial Pneumonia.

    Ayala-Lopez, Nadia / Peaper, David R / Harb, Roa

    American journal of clinical pathology

    2020  Volume 155, Issue 4, Page(s) 537–546

    Abstract: Objectives: Despite extensive research on procalcitonin (PCT)-guided therapy in lower respiratory tract infections, the association between PCT and bacterial pneumonia remains unclear.: Methods: We evaluated retrospectively the performance of PCT in ... ...

    Abstract Objectives: Despite extensive research on procalcitonin (PCT)-guided therapy in lower respiratory tract infections, the association between PCT and bacterial pneumonia remains unclear.
    Methods: We evaluated retrospectively the performance of PCT in patients presenting with lower respiratory tract infection symptoms and grouped by seven diagnoses. All patients had microbial testing, chest imaging, and CBC counts within 1 day of PCT testing.
    Results: Median PCT level in patients diagnosed with bacterial pneumonia was significantly higher than in patients diagnosed with other sources of infections or those not diagnosed with infections. Median PCT levels were not different among patients grouped by type or quantity of pathogen detected. They were significantly higher in patients with higher pathogenicity scores for isolated bacteria, those with abnormal WBC count, and those with chest imaging consistent with bacterial pneumonia. A diagnostic workup that included imaging, WBC count, and Gram stain had an area under the receiver operating characteristic curve of 0.748, and the addition of PCT increased it to 0.778.
    Conclusions: PCT was higher in patients diagnosed with bacterial pneumonia. Less clear is its diagnostic ability to detect bacterial pneumonia over and above imaging and laboratory data routinely available to clinicians.
    MeSH term(s) Adult ; Aged ; Biomarkers/blood ; Female ; Humans ; Male ; Middle Aged ; Pneumonia, Bacterial/blood ; Pneumonia, Bacterial/diagnosis ; Procalcitonin/blood ; Retrospective Studies
    Chemical Substances Biomarkers ; Procalcitonin
    Language English
    Publishing date 2020-10-31
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2944-0
    ISSN 1943-7722 ; 0002-9173
    ISSN (online) 1943-7722
    ISSN 0002-9173
    DOI 10.1093/ajcp/aqaa148
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  7. Article ; Online: Pathologists Overseas

    Emily H. Glynn / Ann Marie Nelson / Merih Tesfazghi / Roa Harb / Timothy Amukele

    Frontiers in Medicine, Vol

    A volunteer-based model for building sustainable, high-quality pathology and laboratory medicine services in low- and middle-income countries

    2022  Volume 9

    Abstract: For thirty years Pathologists Overseas (PO) has worked in low- and middle-income countries (LMICs) to provide affordable, sustainable, and high-quality pathology and laboratory medicine (PALM) services through strategic partnerships and the efforts of ... ...

    Abstract For thirty years Pathologists Overseas (PO) has worked in low- and middle-income countries (LMICs) to provide affordable, sustainable, and high-quality pathology and laboratory medicine (PALM) services through strategic partnerships and the efforts of our large volunteer network. We address low quality diagnostic services by targeting the 3 pillars of PALM quality: human resources, systems, and quality and accreditation. To improve human resource capacity, PO and our partnering organizations provide virtual continuing education to pathologists and laboratory professionals in these countries. To improve systems, we provide laboratory information system installation and implementation support. Lastly, to improve quality and help laboratories progress toward accreditation, we support an external quality assurance program for laboratories in LMICs. As a relatively small organization, PO demonstrates that a network of dedicated volunteers, in partnership with corporations and professional organizations, can initiate sustainable change in the quality of PALM services in LMICs by focusing efforts on the core components of laboratory quality.
    Keywords global health ; health systems strengthening ; low- and middle-income countries (LMICs) ; pathology ; laboratory medicine ; Medicine (General) ; R5-920
    Language English
    Publishing date 2022-08-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Evaluation of Three Commercial Automated Assays for the Detection of Anti-SARS-CoV-2 Antibodies

    Harb, Roa / Remaley, Alan T / Sacks, David B

    Clinical Chemistry

    2020  Volume 66, Issue 10, Page(s) 1351–1353

    Keywords Clinical Biochemistry ; Biochemistry, medical ; covid19
    Language English
    Publisher Oxford University Press (OUP)
    Publishing country uk
    Document type Article ; Online
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvaa193
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  10. Article ; Online: First- and Second-Trimester Reference Intervals for Thyroid Function Testing in a US Population.

    Bunch, Dustin R / Firmender, Kyle / Harb, Roa / El-Khoury, Joe M

    American journal of clinical pathology

    2020  Volume 155, Issue 6, Page(s) 776–780

    Abstract: Objectives: Thyroid dysfunction in pregnancy is associated with increased risk of adverse outcomes to mother and child. Trimester-specific reference intervals for thyroid function tests are not routinely provided by clinical laboratories. In this study, ...

    Abstract Objectives: Thyroid dysfunction in pregnancy is associated with increased risk of adverse outcomes to mother and child. Trimester-specific reference intervals for thyroid function tests are not routinely provided by clinical laboratories. In this study, we present first- and second-trimester-specific reference intervals in a US population for thyroid-stimulating hormone (TSH), free thyroxine (FT4), total thyroxine (T4), and total triiodothyronine (T3) measured on Roche analyzers.
    Methods: We used patient samples from first- and second-trimester prenatal screening. Samples were limited to singleton pregnancies and negative screening results for thyroid peroxidase and thyroglobulin antibodies. Analytes (TSH, FT4, T4, and T3) were measured on a Roche Modular e170 then verified on a Roche cobas e801.
    Results: The reference intervals established on the e170 and verified on the e801 for the first trimester were 0.16 to 2.82 mIU/L for TSH, 12.0 to 18.5 pmol/L for FT4, 62.8 to 177.9 nmol/L for T4, and 1.5 to 3.4 nmol/L for T3. The reference intervals for the second trimester were 0.40 to 3.62 mIU/L for TSH, 10.2 to 16.6 pmol/L for FT4, 66.6 to 176.0 nmol/L for T4, and 1.56 to 3.6 nmol/L for T3.
    Conclusions: This is the first report of trimester-specific reference intervals for thyroid function tests on Roche analyzers in the United States, and it is consistent with worldwide reports.
    MeSH term(s) Adult ; Autoantibodies/blood ; Female ; Humans ; Pregnancy ; Pregnancy Trimester, First/blood ; Pregnancy Trimester, Second/physiology ; Prenatal Diagnosis/methods ; Reference Values ; Thyroid Function Tests/methods ; Thyroid Gland/physiology ; Thyrotropin/blood ; United States
    Chemical Substances Autoantibodies ; anti-thyroglobulin ; Thyrotropin (9002-71-5)
    Language English
    Publishing date 2020-11-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 2944-0
    ISSN 1943-7722 ; 0002-9173
    ISSN (online) 1943-7722
    ISSN 0002-9173
    DOI 10.1093/ajcp/aqaa165
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