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I-CE Igunyaze IKHITHI YOKUHLOLA Isinyathelo esisodwa se-MOP

Incazelo emfushane:


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Ukunemba

Ucwaningo lokuqhathanisa lwenziwa ukuze kuhlolwe ukusebenza kokuhlolwa kwe-MOP One Step Morphine kanye nokuhlolwa okusheshayo kwe-MOP etholakalayo kwezentengiso.Ukuhlolwa kwenziwe esilinganisweni sezibonelo zomtholampilo ezingama-341, kwathi u-10% wezibonelo ezinengxube ye-morphine okungenzeka ukuthi -25% noma +25% yezinga lokunqanyulwa elingu-300 ng/mL.Noma yimiphi imiphumela emihle ecatshangelwayo yaqinisekiswa ngokusetshenziswa kwe-GC/MS.Imiphumela yocwaningo yethulwe kuleli thebula elilandelayo:

Indlela

Okunye ukuhlolwa okusheshayo kwe-MOP

Isamba Semiphumela

MOP Isinyathelo esisodwa

Hlola

Imiphumela

Okuhle

Okubi

Okuhle

159

0

159

Okubi

0

182

182

Isamba Semiphumela

159

182

341

% Isivumelwano ne

le-Rapid Test Kit

100%

100%

100%

Uma kuqhathaniswa ne-GC/MS ekunqanyulweni kwe-300 ng/mL , imiphumela elandelayo yafakwa kuthebula:

Indlela

GC/MS

Isamba Semiphumela

MOP Isinyathelo esisodwa

Hlola

Imiphumela

Okuhle

Okubi

Okuhle

159

10

169

Okubi

0

172

172

Isamba Semiphumela

159

182

341

% Isivumelwano ne

Ukuhlaziywa kwe-GC/MS

100%

94.5%

97.1%

Ukuzwela Kokuhlaziya

Ichibi lomchamo ongenazo izidakamizwa lifakwe i-Morphine ekugxiliseni okulandelayo: 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL kanye no-450 ng/mL.Umphumela ubonisa> ukunemba okungu-99% ku-50% ngaphezulu kanye no-50% ngaphansi kokugxilisa okusikiwe.Idatha ifinyezwa ngezansi:

I-MOP

Ukugxila (ng/mL)

Iphesenti Lokunqunywa

n

Umphumela Obonakalayo

Okubi

Okuhle

0

0

20

20

0

150

-50%

20

20

0

225

-25%

20

20

0

300

Nqamula

20

12

8

375

+25%

20

2

18

450

+50%

20

0

20

Ukucaciswa Kokuhlaziya

Ithebula elilandelayo libala izinhlanganisela ezitholwa kahle emchamweni nge-MOP One Step Morphine Test emizuzwini emi-5.

Inhlanganisela

Ukugxila (ng/mL)

I-codeine

300

I-Ethylmorphine

6,250

IHydrocodone

50,000

I-Hydromorphone

3,125

Levophanol

1,500

6-Monoacethylmorphine

400

I-Morphine

300

I-Morphine 3-bD-glucuronide

1,000

I-Norcodeine

6,250

Normorphone

100,000

I-Oxycodone

30,000

I-Oxymorphone

100,000

I-Procaine

15,000

Thebaine

6,250

UKUSETSHENZISWA OKUHLOSIWE

Ukuhlolwa kwe-MOP One Step Morphine kuyi-lateral flow chromatographic immunoassay ukuze kutholwe i-Morphine emchameni womuntu ekuhlanganiseni okusikiwe okungu-300 ng/mL.Lokhu kuhlola kuzothola ezinye izinhlanganisela, sicela ubheke ithebula le-Analytical Specifity kulokhu kufakwa kwephakheji.

Inzuzo Yethu

Inzuzo Yenkampani :
1. Umkhiqizi Ochwepheshe, inkampani “enkulu” esezingeni likazwelonke
2.Letha izimpahla njengesicelo se-oda
3.ISO13485, CE, Lungiselela imibhalo ehlukahlukene yokuthumela
4.Phendula imibuzo yekhasimende phakathi nosuku olulodwa lwebhizinisi


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