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  1. Article ; Online: Instability of corticotropin during long-term storage - myth or reality?

    Hillebrand, Jacquelien J / Zhou, Li / Marcinkus, Marilee A / Datwyler, Maria / Gawel, Susan H / Martens, Frans / Davis, Gerard J / Heijboer, Annemieke C

    Clinical chemistry and laboratory medicine

    2021  Volume 60, Issue 1, Page(s) 60–65

    Abstract: Objectives: Corticotropin is notorious for its instability. Whereas several studies have investigated its short-term stability in plasma following venous blood sampling, studies on long-term stability are lacking. Here we investigated the long-term ... ...

    Abstract Objectives: Corticotropin is notorious for its instability. Whereas several studies have investigated its short-term stability in plasma following venous blood sampling, studies on long-term stability are lacking. Here we investigated the long-term storage stability of corticotropin in ethylenediaminetetraacetic acid containing plasma.
    Methods: Specimens from healthy volunteers (neat, spiked) were stored in polypropylene microcentrifuge tubes with socket screw-caps at -20 °C and -70 °C for up to one and a half years. Corticotropin in plasma was measured using an Abbott research only immunoassay. Separately, specimens from patients were collected during diagnostic routine testing and stored in polystyrene tubes with push-caps at -20 °C for up to 6 years. In these samples corticotropin hormone was measured using the Diasorin corticotropin immunoassay.
    Results: Storage of specimens at -20 °C or -70 °C for up to one and a half years showed minimal changes (<11%) in corticotropin levels, while storage of patient samples at -20 °C for up to 6 years showed a significant (54%) reduction in corticotropin levels.
    Conclusions: Corticotropin levels are stable in plasma when stored at -20 °C for one and a half years using the Abbott research only assay, but with longer storage time a significant reduction in corticotropin levels can be expected. Once specimens are stored for future corticotropin measurements, one should consider storage time, storage temperature and assay differences.
    MeSH term(s) Adrenocorticotropic Hormone/chemistry ; Edetic Acid ; Humans ; Plasma ; Protein Stability ; Specimen Handling ; Temperature
    Chemical Substances Adrenocorticotropic Hormone (9002-60-2) ; Edetic Acid (9G34HU7RV0)
    Language English
    Publishing date 2021-10-13
    Publishing country Germany
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2021-0818
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay.

    Hemken, Philip M / Israeli, Eitan / Taylor, Russell / Jacobson, Chris / Datwyler, Maria / Geissler, Rene / Hadji, Abbas / Jeanblanc, Nicolette / Pandya, Kinnari / Marcinkus, Marilee / Piktel, Ryan / Bogdan, M Felicia / Rodgers, Mary / Anderson, Mark / Ziemann, Robert / Tieman, Bryan C / Hawksworth, David / Moore, Jeffrey / Otis, Kathy S /
    Marohnic, Christopher C / Corby, Josie / Tu, Bailin / Lin, Zhihong / Kar, Alak / Hartnett, James / Strobel, Carolyn / Gregory, Svetoslava / Rae, Tracey / Muerhoff, A Scott / Brophy, Susan / Hackett, John R / Daghfal, David / Faron, Matthew L / Cruz, Amorina / Mohr, Phaedre / Sokoll, Lori / Davis, Gerard J

    Clinical chemistry and laboratory medicine

    2023  Volume 61, Issue 8, Page(s) 1511–1517

    Abstract: Objectives: To evaluate pre-analytical challenges related to high-volume central laboratory SARS-CoV-2 antigen testing with a prototype qualitative SARS-CoV-2 antigen immunoassay run on the automated Abbott ARCHITECT instrument.: Methods: Contrived ... ...

    Abstract Objectives: To evaluate pre-analytical challenges related to high-volume central laboratory SARS-CoV-2 antigen testing with a prototype qualitative SARS-CoV-2 antigen immunoassay run on the automated Abbott ARCHITECT instrument.
    Methods: Contrived positive and negative specimens and de-identified nasal and nasopharyngeal specimens in transport media were used to evaluate specimen and reagent on-board stability, assay analytical performance and interference, and clinical performance.
    Results: TCID50/mL values were similar for specimens in various transport media. Inactivated positive clinical specimens and viral lysate (USA-WA1/2020) were positive on the prototype immunoassay. Within-laboratory imprecision was ≤0.10 SD (<1.00 S/C) with a ≤10% CV (≥1.00 S/C). Assay reagents were stable on board the instrument for 14 days. No high-dose hook effect was observed with a SARS-CoV-2 stock of Ct 13.0 (RLU>1.0 × 10
    Conclusions: The prototype SARS-CoV-2 antigen ARCHITECT immunoassay is sensitive and specific for detection of SARS-CoV-2 in nasal and nasopharyngeal specimens. Endogenous proteases in mucus may degrade the target antigen, which limits specimen storage and transport times and complicates assay workflow.
    MeSH term(s) Humans ; SARS-CoV-2 ; COVID-19/diagnosis ; Sensitivity and Specificity ; COVID-19 Testing ; Immunoassay
    Language English
    Publishing date 2023-02-20
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2022-1292
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Discovery of a Novel Human Pegivirus in Blood Associated with Hepatitis C Virus Co-Infection.

    Berg, Michael G / Lee, Deanna / Coller, Kelly / Frankel, Matthew / Aronsohn, Andrew / Cheng, Kevin / Forberg, Kenn / Marcinkus, Marilee / Naccache, Samia N / Dawson, George / Brennan, Catherine / Jensen, Donald M / Hackett, John / Chiu, Charles Y

    PLoS pathogens

    2015  Volume 11, Issue 12, Page(s) e1005325

    Abstract: Hepatitis C virus (HCV) and human pegivirus (HPgV), formerly GBV-C, are the only known human viruses in the Hepacivirus and Pegivirus genera, respectively, of the family Flaviviridae. We present the discovery of a second pegivirus, provisionally ... ...

    Abstract Hepatitis C virus (HCV) and human pegivirus (HPgV), formerly GBV-C, are the only known human viruses in the Hepacivirus and Pegivirus genera, respectively, of the family Flaviviridae. We present the discovery of a second pegivirus, provisionally designated human pegivirus 2 (HPgV-2), by next-generation sequencing of plasma from an HCV-infected patient with multiple bloodborne exposures who died from sepsis of unknown etiology. HPgV-2 is highly divergent, situated on a deep phylogenetic branch in a clade that includes rodent and bat pegiviruses, with which it shares <32% amino acid identity. Molecular and serological tools were developed and validated for high-throughput screening of plasma samples, and a panel of 3 independent serological markers strongly correlated antibody responses with viral RNA positivity (99.9% negative predictive value). Discovery of 11 additional RNA-positive samples from a total of 2440 screened (0.45%) revealed 93-94% nucleotide identity between HPgV-2 strains. All 12 HPgV-2 RNA-positive cases were identified in individuals also testing positive for HCV RNA (12 of 983; 1.22%), including 2 samples co-infected with HIV, but HPgV-2 RNA was not detected in non-HCV-infected individuals (p<0.0001), including those singly infected by HIV (p = 0.0075) or HBV (p = 0.0077), nor in volunteer blood donors (p = 0.0082). Nine of the 12 (75%) HPgV-2 RNA positive samples were reactive for antibodies to viral serologic markers, whereas only 28 of 2,429 (1.15%) HPgV-2 RNA negative samples were seropositive. Longitudinal sampling in two individuals revealed that active HPgV-2 infection can persist in blood for at least 7 weeks, despite the presence of virus-specific antibodies. One individual harboring both HPgV-2 and HCV RNA was found to be seronegative for both viruses, suggesting a high likelihood of simultaneous acquisition of HCV and HPgV-2 infection from an acute co-transmission event. Taken together, our results indicate that HPgV-2 is a novel bloodborne infectious virus of humans and likely transmitted via the parenteral route.
    MeSH term(s) Base Sequence ; Coinfection/genetics ; Coinfection/virology ; Female ; Flaviviridae Infections/genetics ; Flaviviridae Infections/virology ; GB virus C/genetics ; Hepacivirus/genetics ; Hepatitis C/genetics ; Hepatitis C/virology ; Hepatitis, Viral, Human/genetics ; Hepatitis, Viral, Human/virology ; High-Throughput Nucleotide Sequencing ; Humans ; Molecular Sequence Data ; Phylogeny ; Real-Time Polymerase Chain Reaction ; Reverse Transcriptase Polymerase Chain Reaction
    Language English
    Publishing date 2015-12-11
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2205412-1
    ISSN 1553-7374 ; 1553-7366
    ISSN (online) 1553-7374
    ISSN 1553-7366
    DOI 10.1371/journal.ppat.1005325
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Performance Evaluation of a Prototype Architect Antibody Assay for Babesia microti.

    Cheng, Kevin / Coller, Kelly E / Marohnic, Christopher C / Pfeiffer, Zachary A / Fino, James R / Elsing, Randee R / Bergsma, Janet / Marcinkus, Marilee A / Kar, Alak K / Gumbs, Orlando H / Otis, Kathy S / Fishpaugh, Jeffrey / Schultz, Phillip W / Pope, Mark R / Narvaez, Alfredo R / Wong, Susan J / Madison-Antenucci, Susan / Leary, Thomas P / Dawson, George J

    Journal of clinical microbiology

    2018  Volume 56, Issue 8

    Abstract: The tick-borne ... ...

    Abstract The tick-borne protozoan
    MeSH term(s) Animals ; Antibodies, Protozoan/blood ; Antibodies, Protozoan/immunology ; Babesia microti/genetics ; Babesia microti/immunology ; Babesia microti/isolation & purification ; Babesiosis/diagnosis ; Disease Models, Animal ; Fluorescent Antibody Technique, Indirect/standards ; Humans ; Immunoassay/instrumentation ; Immunoassay/standards ; Immunoglobulin G/blood ; Immunoglobulin M/blood ; Macaca ; Mass Screening ; Parasitemia/diagnosis ; Polymerase Chain Reaction ; Sensitivity and Specificity ; Seroconversion ; Transfusion Reaction/prevention & control
    Chemical Substances Antibodies, Protozoan ; Immunoglobulin G ; Immunoglobulin M
    Language English
    Publishing date 2018-07-26
    Publishing country United States
    Document type Comparative Study ; Evaluation Studies ; Journal Article
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/JCM.00460-18
    Database MEDical Literature Analysis and Retrieval System OnLINE

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