Sawirka Muuska ah ee COVID-19 Antigen-ka Degdegga ah ee Tijaabada (Dahab Colloidal)

Kasset-ka Tijaabada Degdegga ah ee Antigen-ka ee COVID-19 (Dahab Colloidal)

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ISTICMAALKA KULAN

Cassette-ka Antigen-ka ee degdegga ah ee COVID-19 (Colloidal Gold) waa immunoassay socodka dambe ee loogu talagalay in lagu ogaado tayada SARS-CoV-2 nucleocap-sid antigens ee sanka suufka ee shakhsiyaadka looga shakisan yahay COVID-19 bixiyaha daryeelkooda.

Natiijooyinka waa aqoonsiga SARS-CoV-2 nucleocapsid antigen.Antigen-ka guud ahaan waxaa lagu ogaan karaa suufka sanka inta lagu jiro marxaladda ba'an ee caabuqa.Natiijooyinka wanaagsani waxay muujinayaan joogitaanka antigens fayras, laakiin xidhiidhka kiliinikada ee taariikhda bukaanka iyo macluumaadka kale ee ogaanshaha ayaa lagama maarmaan u ah go'aaminta heerka caabuqa.Natiijooyinka wanaagsani kama saarayaan caabuqa bakteeriyada ama la-qaadista fayraska kale.Wakiilka la ogaaday ma noqon karo sababta dhabta ah ee cudurka.

Natiijooyinka taban kama saarayaan caabuqa SARS-CoV-2 waana inaan loo isticmaalin saldhigga keliya ee daaweynta ama go'aamada maaraynta bukaanka, oo ay ku jiraan go'aamada xakamaynta caabuqa.Natiijooyinka taban waa in lagu tixgaliyaa macnaha guud ee soo-bandhigidda bukaan-socodka, taariikhda iyo joogitaanka calamadaha caafimaad iyo calamadaha la socda COVID-19, oo lagu xaqiijiyo baaritaanka unugyada, haddii loo baahdo maaraynta bukaanka.Qalabkan waxaa loogu talagalay isticmaalka guriga ee ay isticmaalaan dadka caadiga ah meel aan shaybaar ahayn (sida guriga qofka ama goobo aan dhaqameed ahayn sida xafiisyada, dhacdooyinka ciyaaraha, dugsiyada iwm.).Natiijooyinka baaritaanka xirmadan waxaa loogu talagalay tixraaca bukaan-socodka oo keliya.Waxaa lagu talinayaa in la sameeyo falanqayn dhamaystiran oo ku saabsan xaaladda ku salaysan bukaan-socodka muuqaalada bukaan-socodka iyo baaritaano kale oo shaybaar.

KOOBAN

Fayraska novel coronaviruses (SARS-CoV-2) ayaa iska leh genus-ka β.COVID-19 waa cudur faafa oo neef-mareenka oo degdeg ah.Dadku guud ahaan waa u nugul yihiin.Hadda, bukaannada uu ku dhacay cudurka 'coronavirus' cusub ayaa ah isha ugu weyn ee caabuqa;Dadka cudurka asymptomatic-ka ah sidoo kale waxay noqon karaan il faafa.Iyada oo ku saleysan baaritaanka cudurrada faafa ee hadda, muddada soo-baxa waa 1 ilaa 14 maalmood, badiyaa 3 ilaa 7 maalmood.Calaamadaha ugu waaweyn waxaa ka mid ah qandho, daal iyo qufac qalalan.Sanka oo ciriiri ah, diif, cune xanuun, myalgia iyo shuban ayaa laga helaa dhowr xaaladood.

MABADA

Kaassette-ka Antigen-ka ee degdegga ah ee COVID-19 (Nasal Swab) waa immunoassay socodka lateral ee ku salaysan mabda'a farsamada sandwich-ka-labba-ilaaliye.SARS-CoV-2 nucleocapsid borotiinka monoclonal antibody oo ay ku xidhan yihiin unugyo yar-yar oo midab leh ayaa loo istcimaalaa baaraha waxaana lagu buufiyaa suufka isku xidhka.Inta lagu jiro tijaabada, SARS-CoV-2 antigen ee muunada waxay la falgashaa SARS-CoV-2 antibody oo ay weheliso microparticles midab leh taasoo ka dhigaysa antigen-antibody calaamadeysan.Kakan ayaa u haajiray xuubka iyada oo loo marayo ficilka xididdada ilaa xariiqda tijaabada, halkaas oo ay qabsan doonto kahortagga SARS-CoV-2 nucleocapsid borotiinka monoclonal antibody.Khadka tijaabada midabka leh (T) ayaa ka muuqan doona daaqadda natiijada haddii antigens SARS-CoV-2 ay ku jiraan muunada.Maqnaanshaha khadka T wuxuu soo jeedinayaa natiijo xun.Xariiqda xakamaynta (C) waxaa loo isticmaalaa xakamaynta habraaca, waana in had iyo jeer soo baxaa haddii nidaamka tijaabada si sax ah loo sameeyo.

DIGNIIN IYO DIGTOONAADIN

•Isku tijaabinta in vitro diagnostic istcimaalid oo kaliya. Cajalkan tset-ka waa mid hal mar la isticmaalo oo aan dib loo isticmaali karin ama isticmaali karin dad badan.

• Ha u isticmaalin badeecadan sal keliya si aad u baadho ama uga saarto caabuqa SARS-CoV-2 ama si aad u ogeysiiso heerka caabuqa COVID-19.

Fadlan akhri dhammaan macluumaadka ku jira buug-yarahaan ka hor intaadan samaynin baaritaanka.

Ha isticmaalin alaabtan ka dib taariikhda dhicitaanka.

• Cajalka imtixaanku waa inuu ku jiraa kiishka xidhan ilaa inta la isticmaalayo.

Dhammaan shaybaarrada waa in loo tixgeliyaa inay yihiin kuwo khatar ah oo loo maareeyo si la mid ah sida wakiilka faafa.

• Imtixaanka carruurta iyo dhallinyarada waa in lala isticmaalo qof weyn.

• Cajaladda tijaabada ah ee la isticmaalay waa in la tuuraa si waafaqsan shuruucda federaalka, gobolka iyo deegaanka.

• Ha u isticmaalin baaritaanka carruurta ka yar 2 sano.

• Carruurta yaryar waa in lagu dhaqo iyadoo la kaashanayo qof weyn oo labaad.

• Si fiican u dhaq gacmaha ka hor iyo ka dib.

LAXANKA

Agabka la bixiyay

• Tijaabi cajaladaha: cajalad kasta oo ay ku jiraan qalabka wax lagu dhaqo ee ku jira shandad bireed oo gaar ah

• Reagennada Soo saarista ee la sii diyaariyay:

• Dhuumaha jeermis-dilaaca: suufka nadiifka ah ee hal mar la isticmaalo ee muunada ururinta

Gelida xirmada

Alaabta loo baahan yahay laakiin lama bixiyo

•Waqti-saare

Kaydinta iyo Xasiloonida

• Ku kaydi sida baakadeysan ee boorsada xiran heerkulka (4-30℃ ama 40-86℉).Qalabku wuu xasiloonyahay gudaha taariikhda dhicitaanka ee lagu daabacay calaamadaynta.

•Marka la furo boorsada, baaritaanka waa in lagu isticmaalo hal saac gudahood.Soo-gaadhista muddada dheer ee deegaanka kulul iyo qoyaanku waxay sababi doontaa xumaanshaha alaabta.

•Ha barafaysan.

NINKA

Muundooyinka la helay goor hore inta lagu jiro bilawga astaamuhu waxay ka koobnaan doonaan titer-ka ugu sarreeya ee fayraska;shaybaarada la helay shan maalmood ka dib calaamadaha waxay u badan tahay inay keenaan natiijooyin xun marka la barbar dhigo baaritaanka RT-PCR.Ururinta muunadaha oo aan ku filnayn, maaraynta shaybaarka khaldan iyo/ama gaadiidka waxa laga yaabaa inay keenaan natiijooyin been ah;sidaa awgeed, tababarka ururinta muunada ayaa aad loogu talinayaa muhiimada ay leedahay tayada muunada si loo helo natiijooyin sax ah.Nooca shaybaarka ee la aqbali karo ee tijaabinta waa muunada suufka sanka ee tooska ah ee laga helo habka ururinta labada naaro.U diyaari tuubada soo saarista si waafaqsan Habka Tijaabada oo isticmaal suufka nadiifka ah ee lagu bixiyey xirmada ururinta muunada.

Ururinta Muunada suufka Sanka

1.Ka saar suufka xirmada.

2. Madaxa bukaanka u leexi ilaa 70°.

3.1-2 Markaad si tartiib ah u rogrogayso suufka, geli suuf qiyaastii 2.5 cm (1 inch) ah daloolada sanka ilaa iska caabbinta lagala kulmo marawaxadaha.

4. Ku wareeji suufka dhowr jeer dhinaca derbiga sanka oo ku celi sanka kale adigoo isticmaalaya isla suuf.

Gaadiidka Tunyarada iyo Kaydinta

Ha ku soo celin suufka baakadda suufka asalka ah.Muunada cusub ee la ururiyey waa in la farsameeyaa sida ugu dhakhsaha badan, laakiin ugu dambayn hal saac ka dib ururinta muunada.

HABKA IMTIXAANKA

Fiiro gaar ah:Oggolow cajaladaha tijaabada, reagents iyo muunadaha in ay u dhigmaan heerkulka qolka (15-30℃ ama 59-86℉) kahor baaritaanka.

1. Geli tuubada soo saarista goobta shaqada.

2.Dir ka saar shaabadda bireed ee aluminium ee xagga sare ee tuubada soo saarista oo ay ku jirto tuubada soo saarista

3.Sampling waxa loola jeedaa qaybta 'Uruurinta Muunada'.

4. Geli muunada suufka sanka ee tuubada soo saarista kaas oo ka kooban reagent soo saarid.Ku duub suufka ugu yaraan 5 jeer markaad madaxa ku cadaadinayso dhinaca hoose iyo dhinaca tuubada soo saarista.Ku dhaaf suufka sanka ee tuubada soo saarista hal daqiiqo.

5.Ka saar suufka sanka marka aad tuujinayso dhinacyada tuubada si aad dareeraha uga soo saarto suufka.Xalka la soo saaray waxaa loo isticmaali doonaa muunad tijaabo ah.6. Ku dabool tuubada soo saarista caarada dhibcaha si adag.

7. Ka saar cajaladda tijaabada bacda xidhan.

8. U rog tuubada soo saarista muunada, adigoo tuubada si toosan u qabo, ku wareeji 3 dhibcood (qiyaastii 100 μL) si tartiib ah muunada si fiican (S) ee cajalada tijaabada, ka dibna billow saacada.

9. Sug inta ay soo baxayaan khadadka midabka leh.U turjun natiijada 15 daqiiqo.Ha akhrin natiijada 20 daqiiqo ka dib.

[SIFAACA WAXQABADKA]

Waxqabadka Caafimaadka

Si loo qiyaaso jiritaanka caafimaad ee u dhexeeya COVID-19 Antigen Rapid Cassette iyo Comparotor PCR, 628 suuf sanka ah ayaa laga soo ururiyay bukaannada looga shakiyay COVID-19. Xogta kooban ee COVID-19 Antigen Rapid Test Cassette .

COVID-19 antigen		RT-PCR		Wadarta
COVID-19 antigen		Wanagsan	xun	Wadarta
HEO®	Wanagsan	172	0	172
HEO®	xun	3	453	456
Wadarta		175	453	628

PPA =98.28% (172/175), (95%CI: 95.08%~99.64%) NPA =100% (453/453), (95%CI: 99.34%~100%)

PPA - Heshiiska boqolkiiba togan (xasaasnimada) NPA - Heshiiska boqolkiiba taban (gaar ahaan)

Xadka ogaanshaha (Dareenka Falanqaynta)

Daraasadu waxay adeegsatay fayraska SARS-CoV-2 ee dhaqanka leh (Go'doomin USA-WA1/2020 NR- 52287), kaas oo kulaylku firfircoon yahay oo lagu shubay muunada suufka sanka.Xadka ogaanshaha (LoD) waa 1.0 ×10²TCID₅₀/ml.

Falcelinta isdhaafka ah (Taarikhda Falanqaynta)

Falcelinta isdhaafka ah ayaa lagu qiimeeyay iyadoo la tijaabiyay 32 jeermiska noolaha ee la wadaago iyo bakteeriyada laga yaabo inay ku jiraan daloolka sanka.

Wax falcelin iskutallaab ah laguma arag borotiinka MERS-CoV NP ee dib-u-dhaqaajinta ah markii lagu tijaabiyay xaddiga 50 pg/mL.

Wax falcelin iskutallaab ah laguma arag fayrasyada soo socda markii la tijaabiyey xaddiga 1.0 × 106 PFU/mL: Hargab A (H1N1), Hargab A (H1N1pdm09), Hargab A (H3N2), Hargab B (Yamagata), Hargabka B ( Victoria), Adenovirus (nooca 1, 2, 3, 5, 7, 55), Fayraska metapneumovirus,

Fayraska Parainfluenza (nooca 1, 2, 3, 4), Fayraska syncytial ee neefsashada, Enterovirus, Rhinovirus, coronavirus Human 229E, coronavirus Human OC43, coronavirus Human NL63, Human coronavirus HKU1.

Wax falcelin iskutallaab ah laguma arag bakteeriyada soo socota marka lagu tijaabiyo fiirsashada 1.0 × 107 CFU/mL: Mycoplasma pneumoniae, Chlamy-dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (koox A), Streptococcus. Staphylococcus aureus.

Faragelin

Maaddooyinka soo socda ee faragelinta suurtagalka ah ayaa lagu qiimeeyay COVID-19 Antigen Degdegga Tijaabada (Nasal Swab) ee uruurinta hoos ku taxan waxaana la ogaaday inaysan saameyn ku yeelan waxqabadka baaritaanka.

Isku-duubista Walaxda

Mucin 2%

Benzocaine 5 mg/mL Saliida sanka lagu buufiyo 15%

Oxymetazoline 15%

Tobramycin 5 μg/ml Oseltamivir phosphate 10 mg/mL

Arbidol 5 mg/mL

Fluticasone propionate 5%

Triamcinolone 10 mg/mL

Dhiig dhan 4%

Menthol 10 mg/mL

Phenylephrine 15%

Mupirocin 10 mg/mL

Zanamivir 5 mg/mL

Ribavirin 5 mg/mL

Dexamethasone 5 mg/mL

Histamine 10 mg/mL dihydrochloride

Saamaynta Hook-qaadka sare

Kaassette-ka tijaabada degdega ah ee Antigen-ka ee COVID-19 (Dahab Colloidal) ayaa la tijaabiyay ilaa 1.0×10⁵TCID50/ml ee SARS-CoV-2 aan firfircooneyn oo wax saameyn ah oo qiyaasta sare ah lama arag.

Tusmada Astaanta