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Neisseria Gonorrhoeae/Chlamydia Trachomatis/U. Urealyticum Real Time PCR Kit
Molecular diagnostic purchasing depends on sample type, cold-chain capacity, and regulatory evidence, not only assay branding. This Bioperfectus kit lists IVDR status and a 50-test configuration for buyers to verify.
Laboratories running multiplex PCR for sexually transmitted infections must match reagent kits to extraction and amplification workflows. The kit lists male urethral swabs, female cervical swabs, and urine as sample types, with a 5 μL sample input. These details shape collection and processing decisions.
The supplied performance figures are clinical sensitivity of 100% for NG, 100% for CT, and 98.95% for UU. Clinical specificity is listed as 100% for NG, 99.33% for CT, and 99.13% for UU. Local validation remains necessary because performance can shift with extraction methods, instruments, and operator procedures.
Storage is specified at -20±5°C, transportation at -20±8°C, and shelf life at 12 months. Freezer space, dry-ice logistics, and order frequency therefore enter the purchasing decision. The catalogue code MD211403C00201-50T covers a 50-test kit.
The product page identifies regulatory status as IVDR. Procurement teams should verify current instructions for use, intended-use claims, and market-specific documentation before purchase. Scientific China lists sourcing, configuration, MOQ, and logistics support through its quotation process.
For operators, the practical question is not only analytical performance. Sample type, cold-chain handling, regulatory file, and reagent configuration must align with the laboratory’s validation and inventory model. Those details often decide whether a kit can be used routinely.
Why it matters:
Buyers should compare the stated pathogen panel, sample types, storage conditions, and IVDR documentation against their own validation and cold-chain capacity.
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