(234 days)
The BioPlex®2200 Antiphospholipid Syndrome (APLS) IgM kit is a multiplex flow immunoassav intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (B2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders.
The BioPlex 2200 APLS IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Calibrator Set is intended for the calibration of the corresponding BioPlex 2200 APLS IgM Reagent Pack.
The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the corresponding BioPlex 2200 APLS IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 APLS IgM Control Set has not been established with any other Antiphospholipid assay.
BioPlex® 2200 APLS IgM kit includes the following components:
- o One (1) 10 mL vial of Bead Set containing two different populations of dyed beads coated with Cardiolipin (CL) and Beta-2-Glycoprotein I (B2GPI). an Internal Standard bead (ISB). a Serum Verification bead (SVB), and a Reagent Blank bead (RBB) in a MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with glycerol and protein stabilizers (porcine), and ProClin 300 (
Here's a summary of the acceptance criteria and study information for the BioPlex® 2200 Antiphospholipid Syndrome (APLS) IgM kit, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Total precision for Anti-Cardiolipin IgM (serum & heparin) | %CV ≤ 8.1% (High Positive serum) |
| Total precision for Anti-β2GPI IgM (serum & heparin) | %CV ≤ 8.0% (High Positive serum) | |
| Lot-to-Lot Reproducibility | Not explicitly stated but implied by detailed results. | For Anti-Cardiolipin IgM, Total %CV ranged from 5.6% to 11.8%. For Anti-β2GPI IgM, Total %CV ranged from 6.8% to 14.1%. |
| Linearity/Assay Reportable Range | Regression parameters (slope, intercept, r²) for linearity study. Reportable range. | Slopes near 1.00, intercepts near 0.00, r² > 0.99. Reportable range: Anti-Cardiolipin IgM (0.2 to 112 MPL-U/mL), Anti-β2GPI IgM (0.2 to 112 U/mL). |
| Detection Limit (LoQ, LoD, LoB) | Specific values for LoQ, LoD, LoB. | Anti-Cardiolipin IgM: LoQ: 0.2, LoD: 0.13, LoB: 0.0974 MPL-U/mL. Anti-β2GPI IgM: LoQ: 0.2, LoD: 0.13, LoB: 0.1044 U/mL. |
| Analytical Specificity (Interference) | No interference observed with specified substances at maximum levels. | No interference observed with: Hemoglobin (≤500 mg/dL), Bilirubin (unconjugated ≤20 mg/dL, conjugated ≤30 mg/dL), Triglycerides (≤3300 mg/dL), Total Protein (≤12 g/dL), Cholesterol (≤500 mg/dL), Red Blood Cells (≤0.4% (v/v)), Gamma-Globulin (≤6 g/dL), Beta-Carotene (≤0.6 mg/dL), Ascorbic Acid (≤3 mg/dL), Heparin Lithium (≤8000 units/dL), Heparin Sodium (≤8000 units/dL), Sodium Citrate ( |
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).