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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 (< 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives.
• One (1) 5 mL vial of Conjugate containing phycoervthrin conjugated murine . monoclonal anti-human IgM and phycoerythrin conjugated murine monoclonal anti-human FXIII in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with protein stabilizers (bovine), and ProClin 300 (< 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives.
• One (1) 10 mL vial of Sample Diluent containing buffer with protein stabilizers . (bovine and murine), and ProClin 300 (< 0.3%). sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives.

BioPlex® 2200 APLS IgM Calibrator set contains seven 0.5 mL vials of human antibodies to CL or B2GPI in a human serum matrix made from defibrinated plasma with ProClin 300 (≤ 0.3%), sodium benzoate (< 0.1%) and sodium azide (< 0.1%) as preservatives.

BioPlex® 2200 APLS [gM Control set contains four 1.5-mL vials of Positive controls of human antibodies to CL or ß2GPI and two vials of Negative Controls in a human serum matrix made from defibrinated plasma; and, in a human serum matrix made from defibrinated plasma with ProClin 300 (≤0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives.

Additional materials required but not supplied include BioPlex® 2200 Sheath Fluid containing Phosphate Buffered Saline (PBS) with ProClin® 300 (0.03%) and sodium azide (<0.1%) as preservatives; and BioPlex® 2200 Wash Solution containing Phosphate Buffered Saline (PBS) and Tween 20 with ProClin® 300 (<0.03%) and sodium azide (<0.1%) as preservatives.

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

Study Details

1. Sample size used for the test set and the data provenance:

   • Precision/Reproducibility (CLSI EP5-A2):
     • Serum and heparinized plasma panels: Assayed in replicate twice daily over 20 days (n=80) for most samples, and over 10 days (n=40) for mid-negative samples.
     • Data provenance: Not explicitly stated (e.g., country of origin). The study seems to be prospective in nature, conducted specifically for device validation.
   • Precision/Reproducibility (CLSI EP15-A2):
     • Serum panel: Assayed in 4 replicates per run, one run per day over 5 days (n=20).
     • Data provenance: Not explicitly stated. Prospective.
   • Lot-to-Lot Reproducibility:
     • Serum samples: Replicates of 10 for two runs. Total of 60 points for each patient serum sample.
     • Data provenance: Not explicitly stated. Prospective.
   • Linearity/Assay Reportable Range:
     • Six positive patient samples.
     • Data provenance: Not explicitly stated. Prospective.
   • Analytical Specificity (Interference):
     • Not specified how many samples were tested for each substance.
     • Data provenance: Not explicitly stated. Prospective.
   • Cross-Reactivity:
     • Number of samples varied by disease state (e.g., Systemic Lupus Erythematosus: 34, Scleroderma: 20, Syphilis: 15).
     • Data provenance: Samples from individuals with known disease states. Implies retrospective collection of known disease state samples.
   • Assay Cut-off Determination:
     • 103 samples from patients diagnosed as primary or secondary APS.
     • 123 samples from non-APS or other rheumatic disease control donors.
     • 208 samples from apparently healthy donors.
     • Data provenance: Implies retrospective collection for diagnosed patients and prospective for healthy donors.
   • Method Comparison with Predicate Device:
     • 199 patients diagnosed with primary or secondary APS.
     • 346 patients with other rheumatic or non-APS disease.
     • Data provenance: Implies retrospective collection of diagnosed patient samples and controls.
   • Matrix Comparison:
     • 38 matched sets of serum, heparin, and citrate plasma samples.
     • Data provenance: Samples drawn from the same donor. Prospective for matched samples.
   • Clinical Sensitivity and Specificity:
     • 199 diagnosed primary or secondary APS patients.
     • 346 non-APS disease control patients.
     • Data provenance: Implies retrospective collection of diagnosed patient samples and controls.
   • Expected Values/Reference Range:
     • 300 samples from apparently healthy donors (132 males, 168 females).
     • Data provenance: Apparently healthy donors are usually prospectively collected.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set.
   • For the clinical sensitivity and specificity studies, patients were "diagnosed primary or secondary APS patients" or "non-APS disease control patients." It's implied that these diagnoses were established through standard clinical practice, likely involving medical specialists, but specific details on the number or qualifications of clinicians involved in determining these diagnoses are not provided.
   • The assay cutoff determination references "clinical diagnosis as the standard" and the "International Consensus Statement on an Update of the Classification Criteria for Definite Antiphospholipid Syndrome (APS)" for establishing the 99th percentile of a normal healthy population. While this suggests reliance on expert consensus criteria, it doesn't specify experts involved in this specific study's ground truth establishment.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not mention an adjudication method for the test set, as this is a diagnostic assay measuring biomarkers, not an imaging device requiring human reader interpretation and consensus for ground truth. The "ground truth" for clinical performance is based on established clinical diagnoses.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in vitro diagnostic (IVD) immunoassay that directly detects antibodies, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the performance presented for the BioPlex® 2200 APLS IgM kit is its standalone performance. This device is a semi-quantitative immunoassay that produces a numerical result and a positive/negative interpretation based on a pre-defined cutoff. Its performance characteristics (precision, linearity, detection limits, clinical sensitivity/specificity) are evaluated for the device itself, without a "human-in-the-loop" component for result interpretation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The ground truth for most clinical performance evaluations (e.g., clinical sensitivity and specificity, assay cut-off) was based on clinical diagnosis (patients diagnosed with primary or secondary APS vs. non-APS disease controls / apparently healthy donors). This clinical diagnosis would inherently involve a combination of clinical findings, potentially other laboratory tests, and ultimately, a physician's or expert's determination.
   • For analytical performance characteristics (precision, linearity, detection limits, interference), ground truth is established through controlled laboratory experiments and reference methods, not clinical diagnosis in the same way.

7. The sample size for the training set:

   • The document does not explicitly describe a separate "training set" in the context of machine learning. For an IVD immunoassay, the concept of "training" typically refers to the process of developing and optimizing the assay parameters, including reagent concentrations, reaction conditions, and calibrator assignments. This process would use various samples, but they are not typically referred to as a "training set" in the same way as in AI/ML development. The text describes calibrator assignment, which is part of this assay optimization process.

8. How the ground truth for the training set was established:

   • As mentioned above, there isn't an explicit "training set" in the AI/ML sense. For the development and calibration of the assay:
     • Calibrator Assignment: "Calibrator assignment is established for matched lots of BioPlex® 2200 APLS IgM kit and calibrators using a master set of calibrators as reference and replicate analyses on multiple BioPlex® 2200 instruments." This implies a meticulous, data-driven process using a master reference.
     • Assay Cut-off: The cut-off was determined using "concordance testing and Receiver Operator Characteristic (ROC) analysis using the clinical diagnosis as the standard" on a clinical cohort (103 APS, 123 non-APS controls) and later confirmed with 208 apparently healthy donors. This establishment of the cutoff value aligns with how a "ground truth" might be used in an IVD context to define the diagnostic threshold.

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