PSA Prostate Specific Antigen Rapid Test Isixhobo Package Faka

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UKUSETYENZISWA OKUHLOSIWEYO

I-PSA Ultra Prostate Specific Antigen Rapid Test Device (Igazi Elipheleleyo / iSerum / iPlasma) luvavanyo lwe-chromatographic olukhawulezayo lokufumanisa umgangatho we-Prostate Specific Antigen egazini, i-serum okanye i-plasma.

Ikati:TPS-402

Imizekelo:Igazi elipheleleyo/iSerum/Plasma

Inguqulelo: 02

Umhla osebenzeyo:2015-02

Thumela i-imeyile kuthi

Iinkcukacha zeMveliso

Iithegi zeMveliso

Isishwankathelo

I-Prostate specific antigen (PSA) iveliswa yi-prostate glandular kunye neeseli ze-endothelial.Litsheyina elinye le-glycoprotein elinobunzima bemolekyuli malunga ne-34 kDa.1 I-PSA ikhona kwiifom ezintathu eziphambili ezijikelezayo kwi-serum.Ezi fom zikhululekile i-PSA, i-PSA ibophelelwe kwi-α1-Antichymotrypsin (PSA-ACT) kunye ne-PSA ehlanganiswe ne-α2-macroglobulin (PSA-MG) .2
I-PSA ifunyenwe kwizicubu ezahlukahlukeneyo zenkqubo ye-urogenital yamadoda kodwa kuphela iiseli ze-prostate glandular kunye neeseli ze-endothelial zifihla.Inqanaba le-PSA kwi-serum yamadoda anempilo phakathi kwe-0.1 ng / mL kunye ne-2.6 ng / mL.Inokuphakanyiswa kwiimeko ezinobungozi ezifana nomhlaza wesifo seprotate, kwaye kwiimeko ezinobungozi ezifana ne-benign prostatic hyperplasia kunye ne-prostatitis.Inqanaba le-PSA le-4 ukuya kwi-10 ng / mL libhekwa njenge "gray-zone" kwaye ngaphezu kwe-10 ng / mL ibonisa kakhulu umhlaza.3 Izigulane ezinexabiso le-PSA phakathi kwe-4-10 ng / mL kufuneka zihlalutye ngakumbi. idlala lengqula nge biopsy.Abasemagunyeni sele beqalisile ukuphonononga ithuba lokusebenzisa amanqanaba ePSA angaphantsi kwe-4.0 ng/mL njengowona mda uphezulu wesiqhelo wokuhlolwa kweemviwo.Ngokunciphisa i-PSA cutoff ukusuka kwi-4 ukuya kwi-3 ng / mL, ukwanda kokufumanisa umhlaza nge-13.2% kunokufumaneka.4
Uvavanyo lwe-prostate olukhethekileyo lwe-antigen sesona sixhobo sibaluleke kakhulu esifumanekayo sokuxilongwa kwangaphambili komhlaza wesinyi.Izifundo ezininzi ziqinisekisile ukuba ubukho be-PSA yeyona nto iluncedo kwaye inentsingiselo ye-tumor marker eyaziwayo ngomhlaza wesifo seprotate kunye nosulelo lwe-prostate lwe-Benign Prostatic Hyperplasia (BPH) .5) .
I-PSA Ultra Prostate Specific Antigen Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) isebenzisa indibanisela yeconjugate yegolide ye-colloidal kunye ne-anti-PSA antibodies ukufumanisa ngokukhethiweyo zonke iintlobo ezintathu ze-PSA kwigazi elipheleleyo, i-serum okanye i-plasma.Uvavanyo lunexabiso lokunqunyulwa kwe-4 ng / mL.

Umgaqo

I-PSA Ultra Prostate Specific Antigen Rapid Test Device (Igazi Elipheleleyo / iSerum / iPlasma) isemgangathweni, i-membrane esekelwe i-immunoassay yokufumanisa i-PSA kwigazi elipheleleyo, i-serum okanye i-plasma.I-membrane ifakwe ngaphambili kunye ne-PSA antibodies kummandla wovavanyo.Ngexesha lovavanyo, isampuli iphendula kunye nesuntswana elatyiswe nge-anti-PSA antibody.Umxube ufudukela phezulu kwi-membrane chromatographically ngesenzo se-capillary ukusabela kunye ne-anti-PSA antibodies kwi-membrane kwaye ivelise umgca onemibala.Ubukho balo mgca wemibala kwindawo yokuvavanya kubonisa ukuba ubukho be-PSA kwi-specimen bungaphezulu kwe-4 ng / mL yesiphumo esihle, ngelixa ukungabikho kwayo kubonisa umphumo ombi okanye ubukho be-PSA kwi-specimen engaphantsi kwe-4 ng / mL.Ukuze usebenze njengolawulo lwenkqubo, umgca wombala uya kuhlala ubonakala kwingingqi yolawulo (C) ebonisa ukuba umthamo ofanelekileyo we-specimen wongeziwe kwaye i-membrane wicking yenzeke.

Amacandelo eKit

Uvavanyo olupakishwe ngumntu ngamnyeizixhobo	Isixhobo ngasinye sinomgcangei-conjugates enemibala kunye nee-reagents ezisebenzayo zisasazwe kwangaphambili kwiindawo ezihambelanayo.
Iipayipi ezilahlayo	Ukongeza imizekelo sebenzisa.
Isithinteli	I-phosphate buffered saline kunye nepreservative
Faka iphakheji	Ngomyalelo wokusebenza.

Izinto eziphathekayo

Izixhobo ezibonelelweyo

Izixhobo zovavanyo	Iidropha zomzekelo ezilahlwayo.
Isithinteli	Faka iphakheji

Izinto Eziyimfuneko Kodwa Ezingabonelelwanga

Izikhongozeli zokuqokelela imizekelo	ILancets (yeminwe yegazi kuphela)
I-Centrifuge (yeplasma kuphela)	Isibali-xesha
Iityhubhu ze-heparinized capillary ezilahlwayo kunye nebhalbhu yokukhupha (kwigazi elipheleleyo leminwe kuphela)

Ukulumkela

★ Ukusetyenziswa koxilongo lwe-in vitro kuphela.Musa ukusebenzisa emva komhla wokuphelelwa.
★ Uvavanyo kufuneka luhlale kwisingxobo esitywiniweyo de lusetyenziswe.
• Ungatyi, ungaseli okanye utshaye kwindawo apho imizekelo okanye iikiti ziphathwa khona.
★ Musa ukusebenzisa uvavanyo ukuba isingxobo sonakele.
★ Phatha yonke imizekelo ngokungathi inee-arhente ezosulelayo.Qwalasela izilumkiso ezimiselweyo malunga nobungozi be-microbiological kuyo yonke inkqubo kwaye ulandele iinkqubo ezisemgangathweni zokulahla ngokufanelekileyo iisampulu.
★ Nxiba iimpahla ezikhuselayo ezifana neebhatyi zaselabhoratri, iiglavu ezilahlwayo okanye ukhuseleko lwamehlo xa kuvavanywa imizekelo.
★ Ukufuma kunye nobushushu bunokuchaphazela kakubi iziphumo.
Uvavanyo olusetyenzisiweyo kufuneka lulahlwe ngokwemigaqo yendawo.

Ukugcinwa kunye nokuzinza

Gcina njengoko zipakishwe kwisingxobo esivaliweyo nokuba kubushushu begumbi okanye kwifriji (2-30°C).Isixhobo sovavanyo sizinzile ngomhla wokuphelelwa oshicilelweyo kwisingxobo esitywiniweyo.Isixhobo sovavanyo kufuneka sihlale kwisingxobo esivaliweyo de sisetyenziswe.MUSA UKUMKHENZA.Musa ukusebenzisa ngaphaya komhla wokuphelelwa.

Ukuqokelelwa koMfanekiso kunye noLungiselelo

✽ Isixhobo soVavanyo oluKhawulezayo lwe-PSA yeProstate Specific Antigen (igazi elipheleleyo/iSerum/i-Plasma) sinokwenziwa kusetyenziswa igazi elipheleleyo (ukusuka kwi-venipuncture okanye intonga yeminwe), i-serum, okanye iplasma.

✽ Ukuqokelela iisampuli zeGazi leFingerstick:
1.Hlamba isandla sesigulana ngesepha kunye namanzi ashushu okanye ucoce nge-alcohol swab.Vumela ukuba zome.
2.Hlaba ulusu nge-lancet enyumba.Sula uphawu lokuqala lwegazi.
3. Hlikihla ngobunono isandla ukusuka esihlahleni ukuya entendeni ukuya emnweni ukwenza ithontsi legazi elingqukuva kwindawo yokuhlatywa.
4.Yongeza umfanekiso weFingersitck Whole Blood kwisixhobo sovavanyo ngokusebenzisa ityhubhu ye-capillary okanye ithontsi elijingayo.

✽ Yahlula i-serum okanye iplasma egazini ngokukhawuleza ukuthintela ukopha.Sebenzisa kuphela imizekelo ecacileyo, engekho hemolyzed.

✽ Uvavanyo kufuneka lwenziwe ngokukhawuleza emva kokuqokelelwa kwesampuli.Musa ukushiya imizekelo kwiqondo lobushushu begumbi ixesha elide.Iisampuli ze-Serum kunye ne-plasma zingagcinwa kwi-2-8 ° C ukuya kwii-3 iintsuku.Ukugcina ixesha elide, imizekelo kufuneka igcinwe ngaphantsi kwe-20°C.Igazi elipheleleyo eliqokelelwe nge-venipuncture kufuneka ligcinwe kwi-2-8 ° C ukuba uvavanyo luza kuqhutywa phakathi kweentsuku ezi-2 zokuqokelela.Musa ukukhenkcisa iisampuli zegazi elipheleleyo.Igazi elipheleleyo eliqokelelwe ngomnwe kufuneka lihlolwe ngoko nangoko.

✽ Zisa iisampulu kwiqondo lobushushu legumbi phambi kovavanyo.Iisampulu ezikhenkcezisiweyo kufuneka zinyibilike ngokupheleleyo kwaye zixutywe kakuhle phambi kovavanyo.Iisampuli akufuneki zifakwe emkhenkceni kwaye zinyibilike ngokuphindaphindiweyo.

✽ Ukuba iisampulu ziza kuthunyelwa ngenqanawa, kufuneka zipakishwe ngokuhambelana nemigaqo yomanyano equka uthutho lwee-etiologic agents.

Imikhomba-ndlela yokusetyenziswa

Vumela isixhobo sovavanyo, umfuziselo, isithinteli kunye/okanye nezilawuli zilingane nobushushu begumbi (15-30°C) phambi kovavanyo.
1.Zisa isingxobo kunye nesithinteli kwiqondo lobushushu begumbi phambi kokuba uvule isingxobo.Susa isixhobo sovavanyo kwisingxobo esivaliweyo kwaye usisebenzise ngokukhawuleza.Iziphumo ezingcono kakhulu ziya kufumaneka ukuba uvavanyo lwenziwe kwiyure enye.

2.Beka isixhobo sovavanyo kwindawo ecocekileyo kunye nenqanaba.
KwiSerum, iPlasma okanye iVenipuncture Whole Blood specimens: Bamba idropha ngokuthe nkqo kwaye udlulisele ithontsi eli-1 leserum/plasma (malunga ne-40 L) okanye amathontsi ama-2 egazi elipheleleyo (malunga ne-80 L) ukuya kumzekelo wequla (S) lesixhobo sovavanyo. , emva koko yongeza i-1 drop of buffer (malunga ne-40 L) kwaye uqalise isibali-xesha.
Ngomnwe weGazi elipheleleyo:
·Ukusebenzisa ityhubhu ye-capillary: Gcwalisa ityhubhu ye-capillary kwaye ugqithisele malunga ne-80 L ye-fingerstick yegazi elipheleleyo kumzekelo wequla (S) lesixhobo sovavanyo, uze wongeze ithontsi enye ye-buffer (malunga ne-40 L) kwaye uqalise isibali-xesha.
·Ukusebenzisa amathontsi ajingayo: Vumela amathontsi ama-2 ajingayo omfanekiso wegazi elipheleleyo (malunga ne-80 L) ukuba awele embindini wequla lomfanekiso (S) kwisixhobo sovavanyo, emva koko wongeze ithontsi enye yesithinteli (malunga ne-40 L) kwaye uqalise. isibali-xesha.Jonga umfanekiso ongezantsi.

3.Lindela i(imi)layini enemibala.Funda isiphumo ngemizuzu emi-5.Musa ukutolika umphumo emva kwemizuzu eyi-10.

Ukutolikwa kweziPhumo

IZIPHUMO EZINYO:

* Ibhendi enemibala ibonakala kwingingqi yebhanti yolawulo (C) kwaye enye ibhendi enemibala ibonakala kwindawo ye-T band.

IZIPHUMO EZINGAMBI:

Ibhendi enye enemibala ibonakala kwingingqi yebhanti yolawulo (C).Akukho bhendi ivela kummandla webhendi yovavanyo (T).

IZIPHUMO EZINGAVUMI:

Ibhendi yolawulo ayibonakali.Iziphumo zalo naluphi na uvavanyo olungakhange luvelise ibhendi yolawulo ngexesha lokufunda elichaziweyo mazichithwe.Nceda ujonge inkqubo kwaye uphinde ngovavanyo olutsha.Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa ikhithi ngoko nangoko kwaye uqhagamshelane nomsasazi wakho wendawo.

Phawula

1. Ubunzulu bombala kwingingqi yovavanyo (T) bunokwahluka ngokuxhomekeka kugxininiso lwezinto ezijoliswe kuzo ezikhoyo kumzekelo.Ngoko ke, nawuphi na umthunzi wombala kummandla wovavanyo kufuneka uthathwe njengento enhle.Ngaphandle koko, inqanaba lezinto alinakumiselwa ngolu vavanyo lomgangatho.
2.I-specimen enganelanga umthamo, inkqubo yokusebenza engachanekanga, okanye ukwenza iimvavanyo eziphelelwe lixesha zizona zizathu ezinokwenzeka zokungaphumeleli kwebhendi yolawulo.

Ulawulo lwemeko

★ Ulawulo lwenkqubo lubandakanyiwe kuvavanyo.Umgca wombala ovela kummandla wolawulo (C) uthathwa njengolawulo lwangaphakathi lwenkqubo.Iqinisekisa umthamo owaneleyo we-specimen, i-membrane eyaneleyo ye-wicking kunye nobuchule obuchanekileyo benkqubo.
★ Imigangatho yolawulo ayibonelelwanga nale khithi;nangona kunjalo, kucetyiswa ukuba ulawulo oluqinisekileyo nolungalunganga luvavanywe njengenkqubo efanelekileyo yaselabhoratri yokuqinisekisa inkqubo yovavanyo kunye nokuqinisekisa ukusebenza kovavanyo olufanelekileyo.

Ukulinganiselwa

1.I-PSA Prostate Specific Antigen Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) yeyokusetyenziswa kwe-in vitro diagnostic kuphela.Olu vavanyo kufuneka lusetyenziswe ukufunyaniswa komgangatho we-PSA kwigazi elipheleleyo, kwiserum okanye kwisampulu zeplasma.
2.I-PSA Prostate Specific Antigen Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) iya kubonisa kuphela inqanaba le-PSA kumzekelo kwaye akufanelekanga ukuba isetyenziswe njengeyona ndlela yokuxilongwa kwe-Prostate Cancer.
3.Amanani abalulekileyo ezigulane ezine-BPH (ngaphezulu kwe-15%) kwaye ngaphantsi kwe-1% yabantu abaphilileyo baye baphakamisa i-PSA.Nangona iziphumo zovavanyo zilungile, uvavanyo olongezelelweyo lweklinikhi kufuneka luqwalaselwe kunye nolunye ulwazi lwekliniki olukhoyo kugqirha.
Amanqanaba e-4.PSA anokungathembeki kwizigulane ezifumana unyango lwe-hormone okanye i-prostate gland manipulation.

Imilinganiselo elindelekileyo

Olona nqanaba lisezantsi lesalathiso elivunyiweyo jikelele le-PSA kuMhlaza weProstate yi-4 ng/mL kwaye inqanaba lesilumkiso elamkelekileyo yi-10 ng/mL.Imithetho yasekuhlaleni ingachaza amanqanaba ereferensi ahlukeneyo, nceda uqhagamshelane nabasemagunyeni malunga neenkcukacha.I-PSA yeProstate Specific Antigen Rapid Test Device (Igazi Elipheleleyo / iSerum / iPlasma) iye yathelekiswa novavanyo oluphambili lwe-PSA ye-enzyme immunoassay (EIA) yorhwebo.Unxulumano phakathi kwezi nkqubo zimbini yi-98.6%.

Iimpawu zokuSebenza

Uvakalelo kunye neNgcaciso
I-PSA yeProstate Specific Antigen Rapid Test Device (Igazi Elipheleleyo / iSerum / iPlasma) ihlolwe ngovavanyo oluphambili lwe-PSA EIA yorhwebo kusetyenziswa iisampuli zeklinikhi.

Indlela		I-EIA		Zizonke iziphumo
Ultra PSAIsixhobo sokuVavanya ngokukhawuleza	Iziphumo	Okuhle	Ibi	Zizonke iziphumo
	Okuhle	154	4	158
	Ibi	2	266	268
Zizonke iziphumo		156	270	426

I-Relative Sensitivity: 98.7% (95.4% -99.8%)* I-Special Relative: 98.5% (96.3% -99.6%)*
Ukuchaneka: 98.6% (97.0% -99.5%) * *95% iThuba lokuZithemba

Ukuchaneka

I-Intra-Assay
Uvavanyo lwenziwa ukumisela ukuveliswa kovavanyo kusetyenziswa iimvavanyo ze-10 kwiimvavanyo ezintathu ezahlukeneyo kwiqashiso ngalinye kwiqashiso ngalinye kusetyenziswa amanqanaba esampula e-PSA kwi-0 ng / mL, 3 ng / mL, 10 ng / mL kunye ne-20 ng / mL.Iisampulu zichongwe ngokuchanekileyo kwi-98% yexesha.
Inter-Assay
Ukuchaneka okuphakathi kokuqhutywa kuye kwagqitywa ngokusebenzisa amanqanaba amahlanu e-PSA kwi-0 ng / mL, 3 ng / mL 10 ng / mL kunye ne-20 ng / mL ye-PSA kwii-assays ezi-3 ezizimeleyo.Amaqashiso amathathu awohlukeneyo e-PSA Prostate Specific Antigen Ultra Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) avavanyiwe kusetyenziswa le mizekelo.Iisampulu zichongwe ngokuchanekileyo kwi-98% yexesha.
Izinto eziphazamisayo
Ezi zinto zilandelayo aziphazamisi iziphumo zovavanyo kugxininiso olubonakalisiweyo: I-Ascorbic Acid kwi-200 mg/L, iHemoglobin kwi-10 g/L, i-Triglyceride ku-30 g/L, i-Bilirubin kwi-1,000 mg/dL, i-Uric Acid kwi-200 mg/ L.

Uluhlu lweencwadi

1.Wang MC, Valenzuela LA, Murphy GP, et al., Ukuhlanjululwa kwe-prostate ekhethekileyo ye-antigen yomntu.Tyala i-Urol 1979;17: 159-163 .
2.Christens A, Laurell CB, Lilja H. Umsebenzi we-Enzymatic we-prostate-specific antigen kunye nokusabela kwayo kunye ne-extracellular serine proteinase Inhibitors.I-Eur J Biochem 1990;194:755-763.
I-3.Catalona WJ, i-Southurick PC, i-Slawin KM, et al., Ukuthelekiswa kweepesenti zamahhala ze-PSA, ubuninzi be-PSA kunye nokunqunyulwa kwe-PSA yeminyaka yobudala yokufumanisa umhlaza we-prostate kunye nesiteji.Urology 2000 Aug 1:56(2): 255-60.
4.Lodding P, Aus G, Bergdahl S, et al.Iimpawu zokuhlola zifumene umhlaza we-prostate kumadoda angama-50 ukuya kuma-66 ubudala kunye ne-3 ukuya kwi-4 ng./mL.i-prostate ekhethekileyo ye-antigen.Ijenali ye-Urology 159 (3): 899-903, 1998.

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