Eyosulelayo HIV HCV HBSAG KUNYE neSyphilish Rapid Combo Test
INGCACISO YEMVELISO
| Inombolo yoMfanekiso | I-HBsAg/TP&HIV/HCV | Ukupakisha | Iimvavanyo ezingama-20 / ikhithi, 30kits/CTN |
| Igama | HBsAg/TP&HIV/HCV Rapid Combo Test | Ukuhlelwa kwesixhobo | Udidi III |
| Iimbonakalo | Uvakalelo oluphezulu, ukusebenza ngokulula | Isatifikethi | CE/ ISO13485 |
| Ukuchaneka | > 97% | Beka ubomi kwishelufa | Iminyaka emibini |
| Indlela yokusebenza | Igolide yeColloidal | Inkonzo ye-OEM/ODM | Iyafumaneka |
Ukongama
Ixesha lokuvavanya: 15-20mins
Ugcino:2-30℃/36-86℉
Indlela yokusebenza:Igolide yeColloidal
Uphawu:
• Uvakalelo oluphezulu
• iziphumo zokufunda kwimizuzu eyi-15-20
• Ukusebenza ngokulula
• Ukuchaneka okuphezulu
UKUSETYENZISWA OKUHLOSIWEYO
Le khithi ilungele ukuqinisekiswa kwe-in vitro yomgangatho wentsholongwane ye-hepatitis B, i-syphilis spirochete, i-human immunodeficiency virus, kunye nentsholongwane ye-hepatitis C kwi-serum yabantu / i-plasm-ma/iisampulu zegazi elipheleleyo zoxilongo oluncedisayo lwentsholongwane ye-hepatitis B, igcushuwa spirochete, intsholongwane yokungakhuseleki komntu, kunye nosulelo lwentsholongwane ye-hepatitis C. Iziphumo ezifunyenweyo kufunekazihlalutywe kunye nolunye ulwazi lweklinikhi. Yenzelwe ukusetyenziswa ngabasebenzi bezonyango kuphela.
Inkqubo yovavanyo
| 1 | Funda imiyalelo yokusetyenziswa kunye nokuhambelana ngokungqongqo kunye nomyalelo wosetyenziso olufunekayo ukuze ugweme ukuchaphazela ukuchaneka kweziphumo zovavanyo. |
| 2 | Ngaphambi kovavanyo, ikhithi kunye nesampulu zikhutshwa kwimeko yogcino kwaye zilinganiswe kwiqondo lobushushu begumbi kwaye zimakishwe. |
| 3 | Ukukrazula ipakethe yefoyile ye-aluminiyam, khupha isixhobo sovavanyo kwaye usiphawule, emva koko usibeke ngokuthe tye kwitafile yovavanyo. |
| 4 | I-aspirate serum / iisampulu zeplasma kunye ne-dropper elahlayo kwaye yongeza i-2 yehla kwiqula ngalinye le-s1 kunye ne-s2; yongeza amathontsi ama-3 kumngxuma ngamnye s1 kunye no-s2 kwiisampulu zegazi elipheleleyo phambi kokuba wongeze i-1 ~ 2 yamathontsi esisombululo sokuhlanjululwa kumngxuma ngamnye s1 kunye no-s2 kwaye ixesha liqalisiwe. |
| 5 | Iziphumo zovavanyo kufuneka zitolikwe kwimizuzu eli-15 ukuya kwengama-20, ukuba ngaphezulu kwemizuzu engama-20 iziphumo ezitolisiweyo azikho mthethweni. |
| 6 | Ukutolika okubonwayo kungasetyenziswa kwisiphumo sokutolika. |
Qaphela: isampuli nganye iya kubhobhozwa ngepayipi ecocekileyo elahlwayo ukuphepha ukungcoliseka komnqamlezo.
INTSEBENZO YOKHILINI
| Iziphumo zeWIZ zeHBsag
| Iziphumo zovavanyo lweReference reagent | Ireyithi yeziganeko ezintle:99.06% (95% CI 96.64% ~ 99.74%) Ireyithi yeziganeko ezibi:98.69% (95% CI96.68%~99.49%) Iyonke ireyithi yeziganeko: 98.84% (95%CI97.50%~99.47% | ||
| Okuhle | Ibi | Iyonke | ||
| Positive | 211 | 4 | 215 | |
| Ibi | 2 | 301 | 303 | |
| Iyonke | 213 | 305 | 518 | |
| Iziphumo zeWIZ zeTP
| Iziphumo zovavanyo lweReference reagent | Ireyithi yeziganeko ezilungileyo: 96.18% (95% CI 91.38% ~ 98.36%) Ireyithi yesiganeko esibi: 97.67% (95% CI95.64% ~ 98.77%) Iyonke ireyithi yeziganeko: 97.30% (95% CI95.51% ~ 98.38%) | ||
| Okuhle | Ibi | Iyonke | ||
| Positive | 126 | 9 | 135 | |
| Ibi | 5 | 378 | 383 | |
| Iyonke | 131 | 387 | 518 | |
| Iziphumo zeWIZ zeHCV
| Iziphumo zovavanyo lweReference reagent | Ireyithi yeziganeko ezilungileyo: 93.44% (95% CI 84.32% ~ 97.42%) Ireyithi yeziganeko ezimbi:99.56% (95% CI98.42% ~ 99.88%) Iyonke ireyithi yeziganeko: 98.84% (95% CI97.50% ~ 99.47%) | ||
| Okuhle | Ibi | Iyonke | ||
| Positive | 57 | 2 | 59 | |
| Ibi | 4 | 455 | 459 | |
| Iyonke | 61 | 457 | 518 | |
| Iziphumo zeWIZ zeHIV
| Iziphumo zovavanyo lweReference reagent | Umlinganiselo oncomekayo weziganeko: 96.81% (95% CI 91.03% ~ 98.91%) Ireyithi yeziganeko ezimbi:99.76% (95% CI98.68% ~ 99.96%) Iyonke ireyithi yeziganeko: 99.23% (95% CI98.03%~99.70%) | ||
| Okuhle | Ibi | Iyonke | ||
| Positive | 91 | 1 | 92 | |
| Ibi | 3 | 423 | 446 | |
| Iyonke | 94 | 424 | 518 | |
