Search Results

Bionike Laboratories' AQ™ Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Bionike Laboratories' AQ™ Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.

Bionike Laboratories' AQ™ Barbiturate Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the cutoff level of 200 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Bionike AQ™ Barbiturate Test:

Acceptance Criteria and Device Performance Study

The Bionike AQ™ Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates in urine. The device's performance was evaluated against a predicate device (Syva EMIT® II) and confirmed by Gas Chromatography/Mass Spectrophotometry (GC/MS).

1. Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" but rather presents the "reported device performance" from a clinical trial, implying these values met the sponsor's internal criteria for submission.

2. Sample Size and Data Provenance

• Test Set Sample Size: 296 samples for the clinical trial.
• Data Provenance: Not explicitly stated, but the mention of a "clinical trial" generally implies prospective data collection from human subjects. The country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of experts to establish ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth was established by laboratory methods.

4. Adjudication Method for the Test Set

• Adjudication method not applicable in this context. The study primarily compares the device's output to laboratory-derived ground truth (GC/MS) rather than expert consensus on a diagnostic outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This device is a diagnostic assay, not an imaging device requiring human interpretation, so AI assistance for human readers is not relevant.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The reported performance metrics (sensitivity, specificity, accuracy) are for the Bionike AQ™ Barbiturate Test itself, operating without human-in-the-loop performance modifications for interpreting the test result. The device produces a qualitative result (presence or absence of a color band).

7. Type of Ground Truth Used

• Primary Ground Truth: Gas Chromatography/Mass Spectrophotometry (GC/MS). This is considered the "gold standard" for confirming the presence and concentration of drugs in biological samples.
• Initial Comparison: The device was also tested against Syva EMIT® II, a predicate screening method, but GC/MS served as the definitive confirmation for all positive samples.

8. Sample Size for the Training Set

• The document does not specify a separate "training set" sample size. The product description implies an in-house testing phase before the clinical trial, but no details on sample size or methodology for this phase are provided beyond stating, "In-house testing of Bionike Laboratories' AQ™ Barbiturate Test yielded a relative sensitivity or agreement within positives and relative specificity or agreement within negatives of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS." This suggests that the device's development and initial calibration (what might be considered "training") were based on internal data, potentially including samples confirmed by GC/MS, but the specific sample size for this internal "training" is not given.

9. How Ground Truth for the Training Set Was Established

• Based on the in-house testing description, the ground truth for samples used in development (training) would have been established by comparison to the Syva EMIT® II method, and critically, through confirmation by GC/MS for samples documented as positive. This is the same method used for the clinical trial's ground truth. However, specific details about the samples or the process for the "training set" are not provided.

Ask a specific question about this device

Ask a specific question about this device