I-LYHER H.pylori i-Antigen Test Kit ifunyenwe iSatifikethi seMveliso e-Ecuador

Ngomhla we-9 kaNovemba, i-2024, i-LYHER H.pylori Antigen Test Kit iye yaqinisekiswa ngempumelelo yi-Ecuador ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria), igunya lokulawula isixhobo sezonyango e-Ecuador, oku kuthetha ukuba le mveliso ifumene imvume yokufikelela kwimarike e-Ecuador. .

I-LYHER H.pylori i-Antigen Test Kit isebenzisa i-vitro qualitative discovery ye-Helicobacter pylori (Hp) i-antigen kwiisampuli zesitulo somntu ukuncedisa ekuhloleni ubukho be-Helicobacter pylori. I-Hp luhlobo lwebhaktheriya olunokuthi lube koloni kumphezulu we-gastric mucosal epithelial cells. Njengoko iiseli zihlaziywa kwaye zichithwa, i-Hp nayo iya kukhutshwa. Ngokufumanisa i-antigen kwisitulo, sinokwazi ukuba umntu wosulelwe yi-Hp. Le khithi inezi ncedo zilandelayo:

1. · Iziphumo ezikhawulezayo: nciphisa ixesha lokulinda kunye nokuphucula ukusebenza kakuhle kokuxilonga.
2. · Kulula ukufunda iziphumo zovavanyo: zicacile kwaye ziyaqondakala, zivumela abasebenzi bezonyango ukuba benze izigqibo ezikhawulezayo.
3. · Iziphumo ezithembekileyo: izinga lokuchaneka lidlula i-99%, liqinisekisa ukuchaneka kokuxilongwa.

Ikhithi ilungele ukusetyenziswa kwiimeko ezahlukeneyo zokusetyenziswa kobuchwephesha njengezibhedlele, iilabhoratri, iiklinikhi kunye namaziko onyango. Inika indlela esebenzayo yokuhlola kunye nokuxilongwa kwe-Helicobacter pylori kwaye inceda unyango lwakwangoko lwezigulane.

Isiqinisekiso esifunyenwe yi-ARCSA e-Ecuador siphawula okokuqala ukuba imveliso yovavanyo lwe-antigen ye-LYHER ye-H.pylori ifumene isatifikethi sokubhaliswa kwemveliso eMzantsi Melika, ilandela i-China NMPA kunye ne-EU CE isatifikethi. Oku kuthetha ukuba le mveliso ingangeniswa ngokusemthethweni kwaye ithengiswe e-Ecuador, iqhubela phambili isantya sokwanda kwenkampani kwimarike yehlabathi.