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Quanta flash

Manufactured by Inova Diagnostics
Sourced in United States

The QUANTA Flash is an automated chemiluminescent immunoassay (CLIA) system designed for the detection and quantification of autoantibodies in patient samples. It provides a standardized and efficient method for analyzing a wide range of autoimmune biomarkers.

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11 protocols using quanta flash

1

Autoantibody Detection in Rheumatic Diseases

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All samples were also tested for the presence of anti-dsDNA antibodies by chemiluminescence immunoassay (QUANTA Flash, Inova Diagnostics) as previously described (27 (link)) using a cutoff of 70 IU/ml, established in accord with the SLICC classification criterion for anti-dsDNA positivity, which requires that the cutoff for the anti-dsDNA antibody level be above the laboratory reference range (or >2-fold the reference range if tested by enzyme-linked immunosorbent assay) (5 (link)).
Antibodies to proliferating cell nuclear antigen, ribosomal P, recombinant Ro 52/TRIM21, native SSA/Ro 60, SSB/La, Sm, and U1 RNP were detected using the extractable nuclear antigen FIDIS Connective Profile, kit 13 addressable laser bead immunoassay (TheraDiag) on a Luminex 200 flow luminometer, according to the manufacturer’s instructions, and using MLX-Booster software. Other autoantibodies, such as IgG anticardiolipin, IgG anti–β2-glycoprotein 1, and lupus anticoagulant, were measured in a central laboratory as previously described (28 (link)). ANA IIF patterns were classified according to the new ICAP standards (http://www.anapatterns.org/index.php) (9 (link)).
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2

Chemiluminescence Assay for aCL and aβ2GPI

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The study of IgG and IgM aCL and aβ2GPI was performed by chemiluminescence assay (CIA) (QUANTA Flash®, Inova Diagnostics, CA). The cut-off recommended by the manufacturer was 20 chemiluminescent units (CU). However, the low/medium cut-off point (the equivalent of < 40 GPL and MPL units) was defined as 95 CU for IgG aCL and 31 for IgM aCL as previously established (12 (link)).
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3

Serum Calprotectin Measurement for Diagnosis

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Peripheral blood samples were obtained from all participants and serum fraction was separated by centrifugation at 2000 x g for 15 min within an hour of blood extraction before storage at −20°C until use. All available samples from both cohorts were analysed in the Centre of Laboratory Medicine at the Bern University Hospital, Switzerland.
A commercially available enzyme-linked chemiluminescent immunoassay (CLIA) kit for faecal calprotectin (701350, QuantaFlash, INOVA Diagnostics, San Diego, California, USA) was adapted to measure circulating calprotectin in serum samples. Serum concentrations of calprotectin were converted from µg/g stool into µg/mL by multiplying the values by a factor of 0.023. Using a receiver operating characteristic (ROC) analysis in our Swiss cohort, a cut-off of 1.133 µg/mL calprotectin resulted in a sensitivity of 76.92% (95% CI 57.95% to 88.97%) and a specificity of 80.77% (95% CI 62.12% to 91.49%).
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4

Nationwide Children's Hospital's Celiac Disease Evaluation

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Nationwide Children’s Hospital (NCH) is a referral center for evaluation and management of CD in the US. Since July of 2014, patients with differential diagnosis of CD have undergone tTG testing using QUANTA Flash® chemiluminescence assay (INOVA Diagnostics, Inc., San Diego, CA) which has extended analytical range (see Additional file 1) and superior performance for CD [63 (link)–65 (link)]. In addition, all duodenal biopsies at NCH are evaluated by experience pathologists and subject to clinicopathological consensus review.
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5

Antiphospholipid Antibody Measurement

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aCL IgG/IgM/IgA and aβ2GPI IgG/IgM/IgA were measured using QUANTA Flash® (Inova Diagnostics Inc., San Diego, CA, USA) chemiluminescent immunoassays run on the BIO-FLASH® instrument (Biokit s.a., Barcelona, Spain). The cutoff values for the antibodies were defined as 20 chemiluminescent units (CU) as recommended by the manufacturer.
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6

Antiphospholipid Antibodies Testing Protocol

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Serum samples from two different blood draws separated by at least 12 weeks were collected from all patients.
The study of aCL and aβ2GPI IgG and IgM was performed by chemiluminescence assay (CIA) (QUANTA Flash®, Inova Diagnostics, CA). The cutoff recommended by the manufacturer is 20 CU. aPS/PT IgG and IgM determination were performed by ELISA (QUANTA Lite®, Inova Diagnostics, CA). The cutoff recommended by the manufacturer is 30 U/ml. LA was determined according to the International Society of Thrombosis and Hemostasis-Scientific Standardization Subcommittee (ISTH-SSC) guideline (6 (link)).
Triple aPL positivity was considered when the patient had a positive result for aCL and aβ2GPI of IgG/IgM isotype in addition to LA. GAPSS was calculated, taking into account arterial hypertension, hyperlipidemia, and LA, aCL, aβ2GPI, and aPS/PT results.
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7

Autoantibodies and Complement Levels in SLE

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IgG anti-dsDNA autoantibodies were quantified in serum samples by the commercial chemiluminescence immunoassay (CIA) (QUANTA Flash®; Inova Diagnostics, San Diego, CA, USA) in the BIO-FLASH® instrument (Biokit, Barcelona, Spain). The manufacturer’s recommended cut-off was used (20 IU/mL). Moreover, IgG anti-dsDNA autoantibodies were analysed by Crithidia luciliae indirect immunofluorescence test (CLIFT) (Inova Diagnostics, San Diego, CA, USA), with sera diluted 1:10. Results were reported as negative or positive (positive results were arbitrary ranged from 1 to 8 according to fluorescence intensity at fluorescence microscopy in comparison with a positive control (1:160) by trained personnel). The reference value is negative.
Complement (C3, C4) serum levels and activity (CH50) were measured by turbidimetric immunoassay (Atellica CH C3 and Atellica CH C4; Siemens, New York, NY, USA and Autokit CH50; Fujifilm Wako Chemicals, Neuss, Germany, all are tested in Atellica CH Solution, Siemens, New York, NY, USA). Reference values were: 0.870–1.700 g/L for C3, 0.110–0.540 g/L for C4 and 28–60 U/mL for CH50. Hypocomplementemia was considered when either CH50 activity or C3 or C4 levels were lower than reference values.
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8

Quantifying anti-aβ2GPI IgG

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aβ2GPI D1 IgG was measured using QUANTA Flash® (Inova Diagnostics Inc., San Diego, CA, USA) chemiluminescent immunoassay. The cutoff value was ≥ 20 CU as defined by the manufacturer.
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9

Quantification of Circulating Calprotectin

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All samples were analysed in the centre of laboratory medicine in Bern. A commercially available enzyme-linked chemiluminescent assay (CLIA) kit for circulating calprotectin was used (701,365, QuantaFlash, INOVA Diagnostics, San Diego, CA) according to the manufacturer’s instructions.
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10

Quantifying Anti-β2GPI-D1 Antibodies

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The QUANTA Flash b 2 GPI-D1 assay is a novel CIA (Inova Diagnostics, San Diego, USA; CE labelled and 510 k cleared assay) that uses recombinant b 2 GPI-D1 (based on human sequence) coated onto paramagnetic beads and is designed for the BIO-FLASH instrument (Biokit SA, Barcelona, Spain). The principle and protocol of the QUANTA Flash assay system has been previously described. [12] [13] [14] The relative light units (RLUs) are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which in turn is proportional to the amount of anti-b 2 GPI-D1 antibodies bound to the antigen on the beads. Samples above the analytical measuring range were diluted by auto-rerun feature to determine the exact concentration of antib 2 GPI-D1 antibodies. Anti-b 2 GPI antibodies were determined using the QUANTA Lite and the QUANTA Flash b 2 GPI assays (both Inova Diagnostics). Both assays used full-length human native b 2 GPI, obtained as previously described.
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