BioPerfectus

BioPerfectus

Quick notes 

  • Regulatory mix: Broad CE / CE-IVDR coverage across clinical panels; selected RUO assays (e.g., HIV/HBV/HCV VL, Flu H1N1/H3 subtyping, Dengue genotyping).

  • Readout pattern: Most infectious-disease PCRs are qualitative with built-in differentiation; notable quant kits include HPV genotyping (normalized viral load) and EBV Quant, plus HBV/HCV/HIV (RUO).

  • Differentiation/multiplexing is common: many panels distinguish species/subtypes (e.g., Flu A vs B, Dengue 1–4, Norovirus GI vs GII, RSV A/B).

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Main types


HPV & cervical — HPV genotyping (21 types, quant), HPV detection (18 types, qual). CE/NMPA.

STI / urogenital — NG/CT/Ureaplasma multiplex (diff.), HSV pan & 1/2, Mycoplasma (genitalium/hominis), Trichomonas, Treponema, etc. Mostly qual, CE/CE-IVDR/NMPA.

Prenatal & neonatal — SMN1 CNV/deletion, GBS, EBV quant, HCMV. Mix of quant/qual, CE/CE-IVDR.

Respiratory — 7-target viral panel (Flu A/B, RSV, HRV, AdV, Mp, PIV), SARS-CoV-2/FluA/FluB/RSV quad-plex, Flu subtype/variant assays, 3-plex & 7-plex bacterial panels; TB, RSV A/B, MERS/SARS. Qual, mainly CE/CE-IVDR (some RUO).

Gastrointestinal — Enterovirus, CoxA16/EV71, Norovirus (incl. GI/GII), Rotavirus, Adenovirus, Sapovirus, Astrovirus; bacterial GI (E. coli pathotypes, Salmonella/Shigella, C. difficile, etc.). Qual, CE/NMPA.

Vector-borne & parasitic — Zika/Dengue/Chikungunya multiplex (CE), Plasmodium DNA & genotyping (CE-IVDR), broad arboviral/rickettsial single-plexes; Dengue genotyping RUO.

Zoonotic/high-consequence — Monkeypox (std/fast; MPXV/VZV/Variola), Avian Influenza (H5/H7/H9, H5N2, H7N9), VHFs (Ebola/Marburg/Lassa…), Rabies, Y. pestis, B. anthracis. Qual, CE.

Blood-borne / viral load — HIV-1, HBV DNA, HCV RNA quantitative VL assays — RUO.