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Bio flash

Manufactured by Inova Diagnostics
Sourced in United States

BIO-FLASH is an automated chemiluminescent analyzer developed by Inova Diagnostics. It is designed for the detection and quantification of various analytes in clinical laboratory settings.

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4 protocols using bio flash

1

Comprehensive Autoimmune Biomarker Panel Analysis

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For autoimmune biomarker analysis, frozen plasma was shipped on dry ice to Exagen, Inc., which has a clinical laboratory accredited by the College of American Pathologists and certified under the Clinical Laboratory Improvement Amendments. Thawed plasma was aliquoted and distributed for the following tests: antinuclear antibodies (ANA) were measured using enzyme-linked immunosorbent assays (ELISA) (QUANTA Lite; Inova Diagnostics) and indirect immunofluorescence (IFA) (NOVA Lite; Inova Diagnostics); anti-dsDNA antibodies were also measured by ELISA and were confirmed by IFA with Crithidia luciliae; extractable nuclear antigen autoantibodies (anti-Sm, anti-SS-B/La IgG, anti-Scl-70 IgG, anti-U1RNP IgG, anti-RNP70 IgG, anti-CENP IgG, anti-Jo-1 IgG and anti-CCP IgG) as well as RF IgA and IgM were measured using the EliA test on the Phadia 250 platform (ThermoFisher Scientific); IgG, IgM and IgA isotypes of anticardiolipin and anti-β2‐glycoprotein, as well as anti-Ro52, anti-Ro60, anti-GBM, anti-PR3 and anti-MPO, were measured using a chemiluminescence immunoassay (BIO-FLASH; Inova Diagnostics); anti-CarP, anti-RNA-pol-III, and the IgG and IgM isotypes of anti-PS/PT were measured by ELISA (QUANTA Lite; Inova Diagnostics), whereas C-ANCA and P-ANCA were measured by IFA (NOVA Lite; Inova Diagnostics). All assays were performed following the manufacturer’s instructions.
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2

Automated Quantification of Antiphospholipid Antibodies

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Semi-quantitative determination of IgG/IgM aCL and IgG/IgM aβ2GP1 antibodies in human serum was performed on the fully automated BIO-FLASH® instrument (Inova Diagnostics, San Diego, USA) with QUANTA Flash® APS-aCL family and aβ2GP1 family reagents (Inova Diagnostics, San Diego, USA). The QUANTA Flash aCL and aβ2GP1 assays are chemiluminescent two-step immunoassays consisting of magnetic particles coated with cardiolipin and human-purified β2GP1 proteins which capture, if present, aCL and aβ2GP1 anti-phospholipid antibodies from the sample. The emitted light is measured as relative light units (RLUs) by the BIO-FLASH optical system; RLUs are directly proportional to the aCL and aβ2GP1 concentration in samples: manufacturer’s recommended cut-off > 20 CU (chemiluminescent units).
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3

Celiac Serology Assays Comparison

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All diagnostic patient sera were tested with QUANTA Flash  h-tTG IgA from Inova Diagnostics (San Diego, USA) and with EliA Celikey  IgA from Thermo Fisher Scientific (Uppsala, Sweden). The latter analyses were performed in batch on stored serum samples (-18°C).
QUANTA Flash  h-tTG IgA analyses were performed on the BIO-FLASH  (Inova Diagnostics, San Diego, USA) fully automated chemiluminescent immunoassay (CLIA) analyzer. In this assay, purified recombinant human tTG (QUANTA Flash  h-tTG IgA) coated on paramagnetic beads is used as antigen and will react with antibodies from the patient's serum sample. The optical system of the analyzer measures the light induced by the antigen-antibody reaction in relative light units (RLU) and, after conversion, expresses results as chemiluminescent units (CU). The cut-off set by Inova Diagnostics for IgA anti-h-tTG antibody positivity is 20 CU.
The Phadia 250 analyzer (Thermo Fisher Scientific, Uppsala) was used to perform the EliA Celikey  IgA assays. Phadia 250 is an automated fluorescence enzyme immunoassay (FEIA) analyzer. Human recombinant tissue transglutaminase is used as antigen in this assay.
According to the manufacturer's instructions, the cut-off value of the EliA Celikey  IgA assay is 7 U/mL. Test result specific likelihood ratios were calculated using the Bézier method as described in Bossuyt et al. (26) (link).
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4

Automated Anti-DFS70 Antibody Detection

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All samples were tested for the presence of anti-DFS70 antibodies by CIA (QUANTA Flash, Inova Diagnostics Inc.). The assay used purified full length human recombinant DFS70 coated onto paramagnetic beads contained in a reagent cartridge which was loaded onto the analyzer (BioFlash, Inova Diagnostics Inc.). The principles and protocols of the assay have been previously described 4 . The established cut-off for positive anti-DFS70 antibodies was established by Receiver Operator Characteristic (ROC) by the manufacturer (Inova Diagnostics) and validated by the diagnostic laboratory (Mitogen) and set at >20 chemiluminescent units (CU). Monospecific anti-DFS70 autoantibodies was defined as the presence of anti-DFS70 antibodies in the absence of anti-double-stranded DNA (dsDNA) and other autoantibodies detected in the extractable nuclear antigen (ENA) panel described below. Confirmation of IIF DFS70 reactivity was by an absorption immunoassay (HEp-2 Select: Inova Diagnostics Inc.) wherein anti-DFS70 reactivity is specifically removed from positive sera using methods as previously described 23 .
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