Candida albicans/Trichomonas vaginalis Antigen Rapid Test Kit: Reading the Evidence Behind a CE-IVD Assay

Candida albicans/Trichomonas vaginalis Antigen Rapid Test Kit

In diagnostic procurement, a kit’s usable value depends less on a broad label than on its documented configuration, claimed performance, and regulatory pathway. Bioperfectus supplies this combined Candida albicans/Trichomonas vaginalis antigen rapid test as a CE-IVD laboratory product.

The available data separates performance by organism. Candida albicans antigen shows positive agreement of 99.66% (98.12–99.94), negative agreement of 99.16% (98.17–99.61), and total agreement of 99.31% (98.57–99.66). Trichomonas vaginalis antigen shows positive agreement of 96.17% (93.27–97.85), negative agreement of 100.00% (99.47–100.00), and total agreement of 98.91% (98.06–99.39).

Two kit formats are listed: SLC40301W-20T with 20 cassettes, 20 mL sample extraction buffer, 20 extraction tubes, and one instruction sheet; SLC40301W-50T with 50 of each, apart from one instruction sheet. These details matter for bench throughput, storage, and waste planning.

The intended use is rapid diagnostic screening by trained personnel, following instructions, laboratory procedures, and local rules. The source does not specify sample types, time to result, or instrument requirements, so buyers should obtain those details before validation.

CE-IVD status may support some market access, but it does not replace local registration, import, or laboratory verification requirements.

A buyer should confirm the exact claims, instructions for use, shelf life, storage conditions, and traceability documentation.

Why it matters:
Verification of claims, regulatory acceptance, and kit configuration protects both procurement and diagnostic workflows.

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