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'RapidOne' - Opiates Test is a one-step, lateral flow immunoassay for the detection of morphine in urine. 'RapidOne' - Opiates Test is intended for use in the qualitative detection of morphine in human urine at 300 ng/ml.

'RapidOne' - Opiates Test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS) or HPLC.

'RapidOne' - Opiates Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The assay employed in the 'RapidOne' - Opiates Test is based on the same principle of highly specific reaction between antigens and antibodies.

Each assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal goldantibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the 'test' area. The formation of a visible line in the test area occurs when the test is negative.

When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-antibody complex. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the test area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of drug in the urine, and therefore, should be present in all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

Here's a breakdown of the acceptance criteria and study information for the 'RapidOne' - Opiates Test device, based on the provided text:

Acceptance Criteria and Device Performance

• 0 ng/ml: 40/40 negative (>99% precision)
• 225 ng/ml: 24/40 positive (40% precision)
• 300 ng/ml: 40/40 positive (>99% precision)
• 375 ng/ml: 40/40 positive (>99% precision) |

Study Details

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

   • Comparison Study: 90 samples were used in total.
     • 50 were drug-free.
     • 40 contained opiates.
   • Reproducibility Study: For each concentration level (0, 225, 300, 375 ng/ml), 40 tests were conducted (4 times daily for 5 days). This means 40 samples were used at each concentration for this specific test, but the provenance of these "control urines" is not specified beyond being "control urines."
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, laboratory-based evaluations using selected human urine samples.

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

   • The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth for the 40 positive samples was established by GC/MS (gas chromatography/mass spectrometry) and quantified. The 50 drug-free samples were found to be drug-free, implying a similar analytical method or pre-selection.

3. Adjudication method for the test set:

   • Not applicable. The study compares the device's results to a predicate device (Instacheck) and GC/MS results, not to adjudicated expert opinions.

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 MRMC comparative effectiveness study was done. This device is an immunoassay, not an AI-assisted diagnostic tool for human readers.

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

   • This was a standalone performance evaluation of the immunoassay device itself. The results are based on the device's output (presence or absence of a line). While a human interprets the line, the performance characteristics are for the device's ability to produce that visual result.

6. The type of ground truth used:

   • Analytical Testing:
     • For positive samples, Gas Chromatography/Mass Spectrometry (GC/MS) was used for confirmation and quantification.
     • For negative samples, they were "found to be drug-free," implying analytical confirmation.
     • For the reproducibility study, "control urines" with specified concentrations were used.

7. The sample size for the training set:

   • Not applicable. This is a chemical immunoassay, not a machine learning or AI device that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

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