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CoxA16/EV71/EV-U Real Time PCR Kit
Multiplex enterovirus testing is usually bought on run time, storage footprint and documentation — not on the target list alone. The Bioperfectus kit is a CE-IVD-marked assay that bundles CoxA16, EV71 and EV-U into a single throat-swab workflow.
Hand, foot and mouth disease surveillance depends on typing enterovirus results fast enough to inform clinical and public-health decisions. A kit that reads three targets in one run reduces the number of separate assays a laboratory must schedule from a single throat swab.
The supplier lists an assay runtime of 115 minutes, a detection limit of 2.0×10⁻² CCID₅₀/0.1 mL, and storage at -20±5°C. Reported clinical sensitivity is 96.43% for CA16, 100% for EV71 and 98.33% for EV-U, with 100% specificity across all three targets.
Those figures are supplier-reported. A purchasing laboratory should confirm they hold under its own extraction method, thermocycler and sample-handling conditions before treating them as validated local performance.
Two configurations are catalogued: 25 tests per kit and 50 tests per kit. The choice affects batching, waste from unused wells, and how frequently reagents must be reordered against a freezer slot already committed to -20°C storage.
CE-IVD marking is a European regulatory designation. It does not automatically satisfy registration requirements in other jurisdictions, so buyers should verify local acceptance, import documentation and instructions-for-use language before ordering.
Cold-chain handling is the practical constraint. Any delay or temperature excursion between supplier and bench freezer is a reagent-integrity question, not a logistics detail, and it belongs in the supplier agreement.
Why it matters:
A three-target kit can simplify enterovirus workflows, but the real procurement work sits in local validation, cold-chain control and confirming that CE-IVD status matches the market where the results will be used.
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