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Ukutheni Ukukhetha Imibhobho Esheshayo Ephakeme

Aug 05, 2025

Ukubuyekeza Umthombo Womdlalo Ukhululekileyo

Imicaba engenakho ukusebenzisa kabusho kufanele ibalise amathuluzo amathathu okokubalwa kwezicaba zokudla:

  • Ukugcina i-Capacity yokugcina ivolumu elijwayelekileyo lemcaba
  • Ukusebenza kohlelo ukuthi kuthinte >95% yemibceni egcinwe ukuya kwezinye izinhlelo zokuhlola
  • Ukungabi yamagama ayikho ukuthuthukiswa kwezinhlelo zokudlala noma izilwane ezimhljwa

Isicelo sengu-2021 kwi- Isikhathi-soludwana sokudokotela e-Mikrobiyoloji kutholwe izinhlayo ezingenakho umoya ezibonisa ukuthenga kwezinhlobo zokulayisha izimpawu ngama-23% ngaphandle kwezinhlobo eziphambene nezinhlobo eziqine zokudla ezingenakho umoya kuzo zokusebenzisa i-PCR. Le mpikiswano yemiphumela ivumelana nezindlela ezahlukene ngokwemfundiso:

Umthawu Cotton Izinhlayo ezingenakho umoya
Ukugcina Phezulu (200-300% yobunzima) Ikulawuliwe (50-150%)
Ukulayishwa kwezimpawu 65-75% 85-95%
Ukuqondana nezichemikhali Iphendula nge-solvents Iyamelana nama-reagents amaningi
Ingozi Yokuchitheka Kwe-Fiber Kancane Phantsi

Ama-swabs Ekotoni: Izinzuzo Nokulinganiselwa Ekusetshenzisweni Kwemitholampilo

Ukotini we-pharmaceutical grade usakhethwa ekunakekeleni izilonda ngenxa yobumnene bawo bemvelo nokumunca kwawo uketshezi. Nokho, kuvela ukulinganiselwa ezimweni zokuxilonga:

  • Okuqukethwe amafutha acid : Ama-lipid emvelo kakotini angavimbela ukukhula kwamagciwane
  • Ukugcinwa kwe-fibre : Izintambo ezixekethile zingangcolisa amasampula e-cytology asuselwa ku-liquid
  • ukwehluka kwe-pH : Amaphoyisa angasebenzi kutsi aphindwe ukuchemba kwamaphoyisa

Isihlelo esikhohliweyo 2022 sabona ukuthi 34% wezicwancwane zocotton zingeliphi kuityala le-fiber shedding ye-ISO kumatheweni wesembo lokuqala.

Amaphoyisa Amamakheti neTikholoji yeSwab yeFlock

Amaphoyisa amamakheti we-polyester ne-nylon angaphendula izindlela zocotton ngokusebenzisa:

  1. Ukucimela kwezinto ezingenakho umoya kunikeza ukulanda kwezindlela eziphumelelayo
  2. Amaphatha weflock esebenzela ngokujulile kwenza amagxekwa kusurfaces yonke indawo
  3. Amagqabi aphakeme okuphakeme ukuthintwa kwezinto ezingenakho umoya

Ukusebenzisa imithi yokuflocka ukuthola amaceli 40% ngaphezulu kuka-cotton wokugcina nasopharyngeal sampling ( Imikrobiology Clinicale , 2023). Le ndawo ibaluleke kakhulu kuma:

  • Ukufanele kwe-viral transport medium
  • Ukugcinwa okuncane kakhulu kwe-specimen kubufa olwelwe
  • Ukusebenza okufanayo ngokwesilinganiso

I-Teknoloji Yokuflocka Imibhovu & Ukusebenza Kwokuthwasa

Imiphiqo Yemibhovu Yokuflocka Kukutholwa Kwemibhovu

Imibhovu yokuflocka iyasebenzisa imithi yokwenza isayithi esivumelane ukwakhiwa kwe-matrix enobungo obuphezulu. Le ndawo enobungo obuphezulu ikhuthaza:

  • amaphesenti angama-300 angaphezulu kuka-cotton
  • ukuphuthwa kuka-15-25% ngokuthola izimpawu zokuthola
  • Ukuqokelela okuhleweyo yeziphawu zokulondoloza neziseli zepithelitheliyo

Isampuli yamandla vs. Ukuvuleka kweziphawu: Yeyiphi into enqoqo kumafomethi yokuvavanya

Noma isampuli yamandla iyinjani, imithombo yekliniki ibonisa ukuthi ukwabiwa kweziphawu kunezimpawu ezinguquko kumaphethini wokuvavanya:

Inqanawa yemiphumela Izibhobho zokulondoloza Izihlahla eziqile
Ukuvuleka kweziphawu kahulumeni 94% 68%
Isilinganiso sokuvuma engalungileyo 2.1% 5.7%
Ukuphumelela kweselula 89% 63%

Izilaborithile ezinamakhemikhali ezifuna ukuba ngezimalo ezenziwe ngokuhlamvanga zokuthola iziphumo ezinhle xa zisebenzisa izivivinyo nezinhlelo zokuthumela izivirusi.

Izimalo zokuthatha izivivinyo (HydraFlock®) nezibenchmark zomhlaba

Izimalo zokuthatha izivivinyo ezintsha zenzeke ngokuhlamvanga zinezici ezilandelayo:

  1. Isicathamiro sentambo edlulelwe : Okuphakathi kweyiphepha kakhulu ngama-40%
  2. Ukudluliselwa kwebhodwa lesibili : Kuhlanganisa ukuthatha ngokokhawuleza nezokuthola iziphumo ngokokhawuleza
  3. Izimboni ezingenakweyikhemikhali : Vumelane ukushisa (-80°C ukuya kuma-120°C)

Izivivinyo zokuvikisa zibonisa:

  • iirecovery ezingama-69% yamabhaktera ngokwendela kuma-53% ekwiswephe zokusebenzela
  • i-elution eyingcola ngama-25% kuzisistimu ezinezindlela zokusebenzela
  • ukuthunyelwano olungenani lama-99.8%

Izistanda de yesitshalo kanye nezimali zokuphepha kwiiswephe zesiphiwo

EtO vs. Gamma Irradiation: Ukulinganisa Iindlela zokuphepha

Ukuphepha ngegasi le-ethylene oxide (EtO) ligcwalisa iphakheji kepha kudinga ukulahla iphakheji ngama-24-48 iintsuku ukuze kufinyelelwe i-FDA thresholds (≤1 ppm). I-Gamma irradiation iyahlula amagugu kepha ingaba ingaqhelekanga - ingqalelo ye-2023 ye-ASTM yafuneko ukuba kukhuphela ukuphakama ngama-12% kumanye amafayibha e-nylon. Abasebenzisi bekuphakela bafuphakela i-ISO 11135 (EtO) kunye ne-ISO 11137 (gamma) izistanda.

Izixhobo zokuphepha kwiimvundvini zokugqibela kanye nezilaboratori

Izimboniso ezingcono kakhulu kudinga i-Sterility Assurance Level (SAL) ≤10⁻⁶. Kumaqo amaphoyisa, iziqwayiso kufanele zilinde isiqhelo esingcono kwezinsuku eziyi-30-90 ngaphandle kwezimo zokugcinwa zase-ISO 11607. I-Cleanrooms iyasebenza ngokwesiqhelo se-ISO 14644 Isihefu 7/8 (≤352,000 iphethini/m³).

Izimboniso eziphambene nezicathwele

Ukuqinisekiswa Isigaba Izidingo eziphambene
ISO 13485 Ukuphatha Ukudabuka Ukucimisa okuvumelekile, ukulandelana nezinhlobo
FDA 510(k) Ukuvunyelwa kwezwe le-United States Ukuvumelana nezimboniso, imiphango yesililwane
CE Marking Ukuvumelana nezwe le-EU Ukubaluleka kuka EN ISO 11737-1

Ukuvumelanisa Iswephi nezindlela zokusebenzisa eMedicine neLaboratory

Usampli ngokunquma kweNasopharyngeal kunye nokusampli ngokunquma kweOropharyngeal

Izindwandwe zika Nasopharyngeal zisebenzisa amaphoyisa amabi (3-4 mm) anezinhlango zokuphethela eziphethelene ne-nylon, zokugcina izinhlobo zeviral kancane 34% ngaphansi kwezifomu eziphambene. Izindwandwe zika Oropharyngeal zisebenzisa izinhlango eziphakeme eziphethelene ne-polyester ukuxhumana kuzindawo eziphakeme.

Ukuphepha kwenzothixo, Ukudalela nokuxhumana nezinhlobo zemedicine zeviral

Izindwandwe zokudalela zinikeza inkimbinkimbi yokuthola - i-polyurethane engenakho ukutholwa kwezinhlobo kancane 92% ngaphansi kuka-cotton. Izinkinga eziphakeme kuzi zifumaneka:

  • Ukubambeleka kwezinhlobo
  • Ukunyelwa kwezinkimbinkimbi
  • ukushintshwa kwe-pH

Ukuxhumana kweSwephi nezolvente nezinkimbinkimbi

Impahla Ukuxhumana nezolvente Imisebenzo Esheshayo
Polyester Izilwane, acetone Ukuthunyelwa kwe-DNA/RNA
Rayon Izinhlaya eziyinkimbinkimbi, izibizo Izivivinyo zemiphefumulo
PTFE Izinhlaya eziphakeme Ukuthenga kwe-HPLC

Isibonelo esitholile 21% yezinhlaya ezithintekileyo eshishwa kwi-swab-solvent incompatibilities ngokwesibonelo esikhulu 2023.

I-Swabs ephindwe nezimali engaphindwanga

Ukusebenza nokulinganisa ubungozi

Izindlela zokuhlukana kubantu:

Isici Ezimali engaphindwanga Ezimali zokugcina
Amakhotsi Akukho ISO 13485, FDA 21 CFR 820
Imiklankempu yezinto Ayiphawuli Amaphela aphakathi kwe-USP Class VI
Ukugcinwa kwezimali Akukhathiwe Ukucima kwezinhlelo yokucima
Isendvolo yokusebenzela Ukuguqula kumasekhaya Ukudluliselwa kwezilungiselelo

Izindlela ze-CDC zomnyaka 2023 zilungise iindlela zokusebenzela kwezinhlelo zokucima zokuhlolwa kwe-FDA ngisho nezindlela zokuthutha kwezinhlelo zokucima kwezokudla ngokuthi kuzobonakala ukuthutha kwezinhlelo zokucima zokudla. Iizinhlelo eziqinisekileyo zokucima zenza ukuba kube 34% okuningi ukutholwa kwezinto zokuhlola kuzo zokucima kwe-nasopharyngeal.

Imibuzo Evame Ukubuzwa

Yiyiphi into ephambene kakhulu yezinhlelo ezingenayo zokucima ngaphandle kwezinhlelo zokucima zezimbewu?

Izinhlelo ezingenayo zokucima zenza ukuba kube izingxenye zokuthola izinto, ukungcola ukuthi zingatholanga izinkimbini, futhi zenza ukuba kube phezulu ukuthi kuzothathwa kwezimbewu, lokhu kwenza ukuba kube yimali kakhulu kuzo zokudlulisela.

Yini okwenza ukuthi izinhlelo zokucima eziflockwe kuthutha ukutholwa kwezinto?

Izinhlelo zokucima eziflockwe zenza umkhombandlela okuphezulu kwezinhlelo ngezimbewu ezivumelane, ukuthutha ukuthi kuzo zokutholwa, ukuthi kuzo zokuthola, futhi ukuthi kuzo zokutholwa kwezinto eziphakeme.

Yiziphi izindlela zokucima ezisetyenziswayo kuzo zokucima ezinezilungiselelo?

I-Ethylene oxide (EtO) igas faye i-gamma irradiation kuyindlela ejwayelekile yokupheka, nganye enenye le ndlela yokupheka inezimphakathi kanye nezinhawu zokugcina ubunzima bokwelaphi.