The US FDA’s proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing

Inani lobuchwe noma inani lomlelesa wenuzi (uphawu Z) yenhlwa yevanga liyinani lomlelesa osenuzini yechwe. Enuzini evamile, leli nani lilingana nenani lenelesi noma inani lezinelesi ezisenuzini yawo wonke amachwe aleyonhlwa. Inani lobuchwe lingasasetshenziswa njengesihlonzi sezinhlwa zevanga ezivamile. Echweni elivamile elingaleleswanga, inani lobuchwe lilingana nenani lezinzuba.

EChweni elivamile eliqukethe iziNelesi, iziNtunge neziNzuba, isamba senani leChwe Z kanye nenani leNtunge N zakha inani lesisindo seChwe A. Njengoba iziNelesi neziNtunge cishe zinesisindo esifanayo (futhi isisindo seziNzuba zishaywa indiva ngezinjongo eziningi), isisindo seChwe noma yiliphi lapho sivezwa ngomuvo wenani lesisindo seChwe, siphakathi komuvo ekhulwini (1%) walo lonke inani A.

AmaChwe anenani lobuchwe elifanayo kodwana anamanani eziNtunge ahlukene, futhi kanjalo anamanani esisindo ahlukene, aziwa ngokuthi amaChembe. Zingaphezu kwezigamu ezintathu izinhlwa ezitholakala ngokwemvelo eziyizingxube zamaChembe, futhi inani lobuChembe lengxube yeChembe yenhlwa esesimweni esichasisiwe emhlabeni, linqumela ubunzima bechwe obuyindinganiso yenhlwa. Ngokomlando, kwakuyilobo bunzima bechwe bezinhlwa (makuqhathaniswa neHwanzi) obabutholakala ngobuningi obulinganiswa abachazibotho ekhulwini le-19.