Search Results

The KaiBiLi Extended ViralTrans is intended for the collection of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the test site. The KaiBiLi Extended ViralTrans is a culture-based medium that has been validated with multiple sample types and can be used to process clinical specimens using standard laboratory operating procedures for culture of clinical specimens or with other assays that utilize stable recoverable infectious viral particles or bacteria.

The KaiBiLi Extended ViralTrans is room temperature stable and can sustain the viability of virus, chlamydiae, mycoplasma and ureaplasma when transported at 2-8°C or 20-25°C. The product can maintain proper pH environment and inhibit the growth of indigenous microbiota.

KaiBiLi Extended ViralTrans consists of modified Hank's balanced salt solution supplemented with bovine serum albumin, cysteine, glutamic acid, sucrose and HEPES. The HEPES buffer protects against pH changes. Phenol red is used as a pH indicator. Sucrose aids in the preservation of organism viability. To minimize the contamination of commensal organisms, Vancomycin, Econazole Nitrate, and Polymyxin B are incorporated into the medium formula.

KaiBiLi Extended ViralTrans is supplied as one plastic flat-bottom vial along with a screw cap for safely containing and transporting biological specimens. The vial is filled with either 1 mL or 3 mL of transport medium and glass beads, or in a kit format together with collection swabs.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:

  • Shelf Life: Three lots each of the 1 mL and 3 mL configurations (total of 6 lots) of KaiBiLi Extended ViralTrans medium were evaluated. Each lot was tested at time points T=0, 6, 9, 11, and 12 months.
  • Recovery Studies: Performance evaluation was carried out in three lots of media (newly manufactured, middle-aged, and recently expired media).
  • Microorganisms (each tested in corresponding clinical matrix):
    • Viruses (HSV-1, HSV-2, RSV, Cytomegalovirus, Adenovirus, Parainfluenza 3, Influenza A, VZV): Diluted into two different dilutions and tested in triplicate.
    • Chlamydophila pneumoniae: Tested.
    • Mycoplasma pneumoniae, Ureaplasma urealyticum: Diluted into four different dilutions and tested in duplicate for swab elution method, and in triplicate for roll plate method.
  • Clinical Matrices: Negative clinical matrix pools were contrived from a minimum of five donors for each matrix type (Skin, Genital specimens, Nasopharynx, Throat, Blood, Urine).

• Data Provenance: The study appears to be a prospective laboratory study conducted by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. The text does not specify the country of origin of the donors for the negative clinical matrix pools, but the manufacturing company is based in China.

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

This information is not provided in the document. The study describes performance testing of the transport medium's ability to maintain microorganism viability, rather than a diagnostic device that requires expert interpretation of results to establish ground truth. The "ground truth" in this context is the initial microorganism concentration (titer/CFU) at hour zero and its subsequent viability over time, which is measured by laboratory methods (TCID50/mL, IFU/mL, CFU/mL).

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study measures objective quantitative biological viability rather than subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This document describes the performance of a biological specimen transport medium, not an AI-assisted diagnostic device.

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

This information is not applicable. This document describes the performance of a biological specimen transport medium, not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing (recovery studies) was established through:

• Laboratory-measured microbial concentrations: Viral titer (TCID50/mL), Fluorescent Foci Count (IFU/mL) for C. pneumoniae, and Colony Forming Units (CFU/mL or CFU) for M. pneumoniae and U. urealyticum. These quantitative measurements at time zero serve as the baseline "ground truth" to which subsequent measurements are compared.
• Comparison to initial concentration: Changes in recovery were evaluated relative to the initial concentration (time point 0).

8. The Sample Size for the Training Set

This information is not applicable/provided. The performance studies described are for evaluating a finished medical device (transport medium) rather than training a machine learning model.

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

This information is not applicable/provided as no training set for an algorithm is mentioned.

Ask a specific question about this device