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The LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of carisoprodol metabolite (meprobamate) in human urine at a cutoff value of 100 ng/mL when calibrated against meprobamate. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for verification by a confirmatory method such as GC/MS, LC/MS or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative chemical confirmatory method (e.g., gas or liquid chromatography and mass spectrometry) must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment must be exercised with any drug of abuse test, particularly when the preliminary test result is positive.

The LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is a kit comprised of two reagents (antibody/substrate reagent R1 and enzyme-drug conjugate reagent R2), which are bottled separately but sold together within the kit. The Ri solution contains mouse monoclonal anti-meprobamate antibody, glucose-6- phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains meprobamate-labeled glucose-6-phosphate dehydrogenase (G6PDH) in buffer with sodium azide (0.09 %) as a preservative.

Here's a breakdown of the acceptance criteria and the study details for the LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay, based on the provided document:

Acceptance Criteria and Reported Device Performance

• Positive Agreement: 98.5%
• Negative Agreement: 96.6%
  *2 false positives in "Near Cutoff Negative" (92 and 98 ng/mL, both identified as Negative by GC/MS/LC/MS)
  *1 false negative in "Near Cutoff Positive" (103 ng/mL, identified as Positive by GC/MS/LC/MS) |
  | Accuracy (Semi-Quantitative Mode) | High agreement with confirmatory method (LC/MS or GC/MS) for positive and negative samples, particularly around the cutoff. | Semi-Quantitative Analysis Agreement:
• Positive Agreement: 98.5%
• Negative Agreement: 98.3%
  *1 false positive in "Near Cutoff Negative" (98 ng/mL, identified as Negative by GC/MS/LC/MS)
  *1 false negative in "Near Cutoff Positive" (103 ng/mL, identified as Positive by GC/MS/LC/MS) |
  | Reproducibility/Precision (Qualitative Mode) | Consistent results at specific concentrations, especially near the cutoff. | At cutoff (100 ng/mL, GC/MS confirmed 94.9 ng/mL): 40 Negative / 48 Positive out of 88 determinations.
  At -25% Cutoff (75 ng/mL, GC/MS confirmed 76.8 ng/mL): 88 Negative / 0 Positive.
  At +25% Cutoff (125 ng/mL, GC/MS confirmed 122.3 ng/mL): 0 Negative / 88 Positive. |
  | Reproducibility/Precision (Semi-Qualitative Mode) | Consistent results at specific concentrations, especially near the cutoff. | At cutoff (100 ng/mL, GC/MS confirmed 94.9 ng/mL): 60 Negative / 28 Positive out of 88 determinations.
  At -25% Cutoff (75 ng/mL, GC/MS confirmed 76.8 ng/mL): 88 Negative / 0 Positive.
  At +25% Cutoff (125 ng/mL, GC/MS confirmed 122.3 ng/mL): 0 Negative / 88 Positive. |
  | Linearity/Reportable Range | Acceptable recovery across a range of concentrations. | Mean Recovery: 66.6% to 109.2% for expected concentrations from 10 ng/mL to 400 ng/mL. (Note: 10 ng/mL showed lower recovery, but higher concentrations were generally good). |
  | Analytical Specificity (Endogenous Compounds) | No interference from common endogenous compounds at specified concentrations. | No positive or negative interference observed for the listed endogenous compounds when meprobamate was at -25% or +25% of the cutoff. |
  | Analytical Specificity (Urine Preservatives) | No significant interference from common urine preservatives. | Sodium azide and sodium fluoride: No interference.
  Boric acid: Caused false negative results at +25% cutoff (125 ng/mL) and up to +125% cutoff (225 ng/mL). Labeling mitigation required. |
  | Analytical Specificity (pH) | No interference across a physiological pH range. | No positive or negative interference observed at urine pH values ranging from 3 to 11. |
  | Analytical Specificity (Specific Gravity) | No interference across a physiological specific gravity range. | No positive or negative interference observed at urine specific gravities ranging from 1.002 to 1.029. |
  | Cross-Reactivity (Structurally Related Compounds) | Acceptable cross-reactivity profile. | Carisoprodol (90.9%), Felbamate (25.0%), Meprobamate-N-Glucuronide (0.5%), Hydroxymeprobamate (0.2%). Other listed compounds showed

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