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Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid Ekol of one of the more regioner in vitro diagnostic test kit for the qualitative detection of human phonic Gonadotropin (hCG) in urine.

Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid Ekol of one of the more regioner in vitro diagnostic test kit for the qualitative detection of human phonic Gonadotropin (hCG) in urine. Excel OneStep Urine hCG Pregnancy DipStick Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.

The Principle of Excel OneStep Urine hCG Pregnancy DipStick Test is as follows:

• Both the Excel OneStep Urine hCG Pregnancy DipStick and the QuikStrip (or E.Z. Strip) Pregnancy Home 1. tests are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the Excel OneStep Urine hCG Pregnancy DipStick is placed in a urine test cup containing the urine specimen, the urine will migrate by capillary action. The gold sol-antibody conjugate in the gold sol pad of the Excel OneStep Urine hCG Pregnancy DipStick binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the positive reaction zone in the white membrane area and produces a rose-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly.

This document describes the Excel OneStep Urine hCG Pregnancy DipStick Test, a qualitative in vitro diagnostic test for human chorionic gonadotropin (hCG) in urine. The study presented compares its performance to the Syntron Quikpac EIA, a currently marketed hCG assay.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the Excel OneStep device in a quantitative manner (e.g., sensitivity, specificity thresholds). However, it establishes a comparison to an existing, marketed device, the Syntron Quikpac EIA. The implication is that the Excel OneStep device should perform comparably to the Syntron Quikpac EIA, particularly in its cutoff sensitivity.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify the sample size used for the comparative study or test set.
• Data Provenance: The document states the study is "based on comparative data with Syntron Quikpac EIA," but does not mention the country of origin of the data or whether it was retrospective or prospective. It appears to be an internal comparison or validation study, not a large-scale clinical trial with detailed demographics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• The document does not provide information about the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method.

5. 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

• This is a qualitative diagnostic test (a dipstick for visual detection of a rose-pink band). It does not involve AI, human readers interpreting complex images, or an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This is a standalone diagnostic test in the sense that the device itself produces the result (a color change). There is no "algorithm only" performance separate from the physical dipstick reaction, as it's a chemical immunoassay, not an AI or software-based algorithm. The interpretation is visual by a human, but the test itself is complete upon color change.

7. The Type of Ground Truth Used

• The ground truth is implied to be actual hCG concentrations in urine specimens, as demonstrated by a qualitative cutoff of "25 mIU/mL". This is a biochemical or analytical ground truth (presence/absence of hCG at a specific threshold) rather than expert consensus on images or pathology. The performance is gauged against an existing, marketed device, the Syntron Quikpac EIA, which presumably has its own established analytical performance standards.

8. The Sample Size for the Training Set

• The document describes a comparative study, not a machine learning study that would typically involve distinct training and test sets. Therefore, there is no mention of a training set sample size.

9. How the Ground Truth for the Training Set was Established

• As there's no mention of a training set, this information is not applicable.

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