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Trinity Biotech Uni-Gold™ Giardia is a single use rapid immunoassay for the qualitative detection of Giardia lamblia ( G. lamblia ) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Giardia gastrointestinal infections. As with other Giardia tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

The Trinity Biotech Uni-Gold™ Giardia was designed as a single use, rapid, lateral flow immunoassay test device to detect the presence of Giardia lamblia antigen in unpreserved (fresh & frozen), preserved and media containing human stool specimens.

The Trinity Biotech Uni-Gold™ Giardia test strip (5mm x 60mm) combines a Nitrocellulose Membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.

The Giardia Nitrocellulose Membrane Test Strip - above consist of

• A) Mouse anti-Giardia lamblia antibody is coated onto the Test Line region of the test strip.
• B) Rabbit anti-Goat IgG antibody is coated onto the Control Line region of the Test Strip.
• C) Goat anti- Giardia lamblia antibodies and Goat IgG antibodies are conjugated to red latex particles and dried onto the inert glass fiber (Conjugate Pad) which is inserted into the test strip below the nitrocellulose zone.

When Giardia antigens are present in the sample they combine with the antibody/red latex complex. As the complex migrates it binds to the antibodies in the test region forming a visible pink/red band. (Picture B) This forms the basis for the double antibody sandwich assay. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device. This internal control line is to ensure and indicate that the test device is functioning correctly.

The plastic housing device contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes.

The test concept:

Mouse anti-Giardia lamblia is coated onto the test line region of the nitrocellulose zone of the test strip. Rabbit anti- Goat IgG is coated onto the control line region.

Goat anti-Giardia lamblia antibodies are conjugated to red latex particles and dried onto inert glass fiber. This is inserted into the test strip below the nitrocellulose zone.

A buffered solution is added to a dilution tube followed by the addition of the stool specimen (2 drops) via a disposable pipette. This mixture is then dispensed in total into the sample well of the lateral flow cartridge device with a dropper pipette and migrates through a pad containing red microspheres that have been coated with a antibody specific for the Giardia antigen. If the antigen is present, an immune complex forms. The migration continues along the membrane, which contains a striped down anti Giardia capture antibody. If Giardia antigen is present, the immune complex reacts with the anti-Giardia antibody at the test line on the membrane.

Thus Giardia antigens present in the sample combine with the antibody/red latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band.

Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly.

Here's a summary of the acceptance criteria and the study details for the Uni-Gold™ Giardia device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative format (e.g., "Sensitivity must be >90%"). However, based on the studies presented, the implicit acceptance criteria are 100% agreement/sensitivity/specificity in the evaluated studies.

2. Sample Sizes and Data Provenance

• Test Set for Agreement vs. Comparator Device:

  • Total Samples: 267 retrospective samples.
  • Matrix types: unpreserved frozen (42), C&S (15), SAF (139), and formalin (71).
  • Country of Origin: Not explicitly stated, but the studies were conducted at 3 external laboratories. Given the "US and Canada" mention for overall sample collection, it's likely from these regions.
  • Retrospective/Prospective: Retrospective.

• Test Set for Sensitivity/Specificity vs. DFA Microscopy (Retrospective):

  • Total Samples: 241 (91 positive, 150 negative).
  • Positive matrix types: formalin (48), SAF (13), unpreserved frozen (17), Cary Blair (3), and C&S (10).
  • Negative matrix types: formalin (42), SAF (70), unpreserved frozen (25), Cary Blair (3), and C&S (10).
  • Country of Origin: Not explicitly stated, but collected from "Hospitals throughout the US and Canada."
  • Retrospective/Prospective: Retrospective.

• Test Set for Additional Retrospective Studies (Non-Fluorescent Microscopy):

  • Site 2 (Wheatley's Stain): 67 retrospective samples (22 positive, 45 negative).
  • Site 3 (Iron Hematoxylin Stain): 259 retrospective samples (60 positive, 199 negative).
  • Country of Origin: Not explicitly stated, but likely from "US and Canada."
  • Retrospective/Prospective: Retrospective.

• Test Set for Prospective Study (DFA Microscopy):

  • Total Samples: 378 negative samples.
  • Matrix types: unpreserved fresh (153), unpreserved frozen (45), formalin (45), SAF (45), C&S (45), and Cary Blair (45).
  • Country of Origin: Not explicitly stated, but collected from "Hospitals throughout the US and Canada."
  • Retrospective/Prospective: Prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the "number of experts" used to establish ground truth or their specific qualifications (e.g., "Radiologist with 10 years of experience"). However, the ground truth methods (DFA microscopy, Wheatley's Stain, Iron Hematoxylin Stain) are laboratory diagnostic techniques typically performed by trained medical technologists or laboratory personnel. It implies that these established methods served as the expert-level reference.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by the reference methods (DFA microscopy, Wheatley's Stain, Iron Hematoxylin Stain). In cases where the Uni-Gold device and the initial comparator device disagreed (e.g., in the "Agreement vs. Comparator Device" study), further resolution was sought through DFA microscopy or Iron Hematoxylin Stain, which effectively acted as an adjudicator to determine the true positive/negative status for those discrepant samples.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. The study compares the device performance to established laboratory methods or an existing comparator device, not the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was evaluated. The studies directly compare the Uni-Gold™ Giardia device's results (algorithm only, as it's a rapid immunoassay) against the chosen established ground truth methods (DFA microscopy, non-fluorescent microscopy, or a comparator device). There is no "human-in-the-loop" aspect to the device's reading mechanism described.

7. Type of Ground Truth Used

The types of ground truth used were primarily:

• DFA Microscopy: Direct Fluorescent Antibody microscopy.
• Non-Fluorescent Microscopy: Specifically, Wheatley's Stain and Iron Hematoxylin Stain.
• Comparator Device: Remel Xpect™ Giardia Lateral Flow Assay (510K #: K031942) for initial agreement studies, with discrepant results often adjudicated by DFA or Iron Hematoxylin Stain.

8. Sample Size for the Training Set

The document describes a rapid immunoassay device. It does not mention a "training set" in the context of machine learning. The device is a chemical/immunological test, not an algorithm that requires a training set in the AI sense. The development of the assay itself would have involved internal validation and optimization, but not a distinct "training set" as understood in AI studies.

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

As there is no "training set" for an AI algorithm, this question is not applicable to the Uni-Gold™ Giardia immunoassay device.

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