Search Results

The BE CERTAIN™ Home Pregnancy Test is intended for the qualitative identification of the elevated level of Human Chorionic Gonadotrophin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter consumer use.

The BE CERTAIN™ Home Pregnancy Test is an hCG assay, comprising of a rapid one-step test, based on an immunochromatographic technology. The test is made up of a membrane with an absorbent pad overlapping a strip of fiber glass paper that is impregnated with a lyophilized colloidal conjugate of gold particles and monoclonal solid phase antibodies to hCG. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into the device and proceeds through the absorbent pad, then laterally onto a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the hCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-hCG monoclonal antibody affixed on the test zone ("T") will bind the hCG-gold conjugate complex, forming a pink line ("T"). All samples will cause a pink colored line to appear in the control zone ("C"). This line is formed by the binding of the polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly. In less than 5 minutes, levels of hCG as low as 25mlU/ml can be detected.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for BE CERTAIN™ Home Pregnancy Test

The BE CERTAIN™ Home Pregnancy Test is intended for the qualitative identification of Human Chorionic Gonadotrophin (hCG) in urine to aid in the determination of pregnancy for over-the-counter consumer use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sensitivity/Detection Limit:
  • Sample Size: 30 human urine samples from different non-pregnant male or female subjects (used as a base for spiking). For each hCG concentration, 5 samples were tested.
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared samples using human urine, therefore likely prospective/controlled.
• Specificity (LH, FSH, TSH):
  • Sample Size: 45 human urine samples from different normal, non-pregnant females. For each hormone concentration/condition, 5 samples were tested.
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared samples using human urine, therefore likely prospective/controlled.
• Interfering Substances:
  • Sample Size: Human urine samples from non-pregnant female or male subjects. For each analyte/condition, 3 samples were tested.
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared samples using human urine, therefore likely prospective/controlled.
• pH Interference:
  • Sample Size: Human urine samples. For each pH level, 1 sample was tested.
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared samples using human urine, therefore likely prospective/controlled.
• Clinical Performance (Dip Method):
  • Sample Size: 100 spiked human urine samples from normal, non-pregnant females.
  • Data Provenance: Not explicitly stated, but "spiked human urine samples" suggests controlled laboratory setting, thus prospective. Country of origin not specified.
• Clinical Performance (Urine Dropstream Method):
  • Sample Size: 50 spiked human urine samples from normal, non-pregnant females.
  • Data Provenance: Not explicitly stated, but "spiked human urine samples" suggests controlled laboratory setting, thus prospective. Country of origin not specified.

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

• For the non-clinical (sensitivity, specificity, interference) studies: The "ground truth" was established by the precise spiking of hCG and other hormones/substances into known negative urine samples. This is a deterministic ground truth based on measurable concentrations, not expert interpretation.
• For the clinical performance studies:
  • There was a "professional user" who tested the BE CERTAIN™ device using the dip method and the E.P.T.® Pregnancy Test (predicate device).
  • The qualifications of this "professional user" are not specified.
  • The "ground truth" for these comparative studies was essentially the results of the professional user's application of the predicate device or the subject device itself, not an independent, higher-level ground truth like pathology. The comparison itself forms the "truth" for concordance purposes.

4. Adjudication Method for the Test Set

• There is no explicit mention of an adjudication method in the context of resolving discrepancies for any of the studies. All results are presented as direct counts of positives/negatives based on the test's outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a typical MRMC comparative effectiveness study was not explicitly conducted as described for AI devices assessing complex medical images.
• However, comparative studies were performed:
  • The BE CERTAIN™ test results by an "End User" were compared to the BE CERTAIN™ test results by a "Professional User" (Table 5). This can be seen as comparing two "readers" (end-user vs. professional) on the same "cases" (spiked urine samples).
  • The BE CERTAIN™ test results by an "End User" were compared to the E.P.T.® Pregnancy Test results by a "Professional User" (Table 6 and Table 7). This compares one device used by one type of reader against another device used by another type of reader.
• Effect size of human readers improvement with AI vs without AI assistance: This is not applicable, as this is a diagnostic test kit, not an AI assistance tool for human readers interpreting data. The studies focused on device performance and user equivalence.

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

• This is not applicable in the classical sense for an "algorithm only" device. The BE CERTAIN™ Home Pregnancy Test is an in-vitro diagnostic device that requires human interaction to perform the test and interpret the visual result (presence or absence of colored lines).
• However, the non-clinical studies (sensitivity, specificity, interference) can be considered "standalone" in the sense that they evaluated the chemical and immunological performance of the device without direct consideration of "end-user" variability in interpretation, focusing on the inherent capability of the test strip itself under controlled conditions. The "professional user" studies also represent a controlled, expert application of the device.

7. The Type of Ground Truth Used

• Non-clinical studies (Sensitivity, Specificity, Interference): Quantitative spiking of hCG and other substances into known negative urine samples. This is a manufactured or controlled standard ground truth based on known concentrations.
• Clinical performance (Comparison studies): The "ground truth" was established by comparing the results of the BE CERTAIN™ Home Pregnancy Test (either by end-user or professional user) against:
  • The results of the BE CERTAIN™ Home Pregnancy Test performed by a professional user (seen as a reference for the device's intended performance).
  • The results of the legally marketed predicate device (E.P.T.® Pregnancy Test) performed by a professional user.
  • Therefore, the ground truth here is largely a comparative reference standard based on an already cleared device and/or expert application of the new device.

8. The Sample Size for the Training Set

• This device is an immunochromatographic test kit, not an algorithm that undergoes a "training phase" with a training set of data in the typical machine learning sense. There is no explicit mention of a "training set" for the device itself.
• The development process would involve R&D and optimization, but not "training data" in the AI context.

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

• As there is no "training set" in the context of an algorithm, this question is not applicable. The development of the device would have relied on established biochemical principles and experimental validation during its design phase.

Ask a specific question about this device