Jumlada COVID-19 Soosaarayaasha iyo alaab-qeybiyeyaasha Antigen-ka Degdegga ah ee Tijaabada (Colloidal Gold) |HEO

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 loogu talagalay]
Cassette-ka Antigen-ka ee degdegga ah ee COVID-19 (Saliva) waa tallaal-socodka dabadeed ee loogu talagalay in lagu ogaado tayada SARS-CoV-2 nucleocapsid antigens ee candhuufta laga helo shakhsiyaadka looga shakisan yahay COVID-19 bixiyehooda daryeel caafimaad.
Natiijooyinka waa aqoonsiga SARS-CoV-2 nucleocapsid antigen.Antigen-ka guud ahaan waxaa lagu ogaan karaa candhuufta 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.
Cassette-ka Antigen ee Degdegga ah ee Tijaabada (Saliva) ee COVID-19 waxaa loogu talagalay inay adeegsadaan xirfadlayaal caafimaad ama hawl-wadeenno tababaran kuwaas oo si fiican u yaqaanna samaynta tijaabooyinka socodka dambe.Alaabta waxaa loo isticmaali karaa shaybaadh kasta iyo deegaan aan shaybaadhka ahayn oo buuxiya shuruudaha lagu qeexay Tilmaamaha Isticmaalka iyo qawaaniinta deegaanka.
[kooban]
Fayraska novel coronaviruses (SARS-CoV-2) ayaa iska leh p genus.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.
[PRINCIPLE]
Kaassette-ka Antigen-ka ee degdegga ah ee COVID-19 (Saliva) waa tallaal-socodka dabadeed ee ku salaysan mabda'a farsamada sandwich-ka-labba-ilaaliye.SARS-CoV-2 nucleocapsid borotiinka monoclonal antibody oo ay weheliyaan unugyo yaryar 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 capillary ilaa khadka 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 TIRADARO]
• Isticmaalka ogaanshaha in vitro ee kaliya.
• Xirfadlayaasha daryeelka caafimaadka iyo shakhsiyaadka loo tababaray goobaha daryeelka.
• Ha u isticmaalin badeecadan sida saldhigga keliya si aad u baadho ama uga saarto
Infekshanka SARS-CoV-2 ama in lagu wargeliyo heerka caabuqa COVID-19.
Ha isticmaalin alaabtan ka dib taariikhda dhicitaanka.
Fadlan akhri dhammaan macluumaadka ku jira buug-yarahaan ka hor intaadan samaynin baaritaanka.
• 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.
• Cajaladda tijaabada ah ee la isticmaalay waa in la tuuraa si waafaqsan shuruucda federaalka, gobolka iyo deegaanka.
[COMPOSITION]
Agabka la bixiyay
• Tijaabi cajaladaha: cajalad kasta oo ay ku jiraan qalabka wax lagu dhaqo ee ku jira shandad bireed oo gaar ah
• Reagents soo saarista: ampoule ka kooban 0.3 ml oo ah reagent soo saarista
• Candhuufta ururisa
• Tuubooyinka aruurinta
•Dhibaatooyinka
Gelida xirmada
Alaabta loo baahan yahay laakiin lama bixiyo
•Waqti-saare
[KAYDKA IYO XASAANADA]
• Ku kaydi sida baakadeysan ee boorsada xiran heerkulka (4-30°C ama 40-86T).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.
LOT iyo taariikhda dhicitaanka ayaa lagu daabacay calaamadda.
[Ururinta iyo DIYAARINTA NOOSKA AH]
Ha gelin wax afka ah oo ay ku jiraan cunto, cabbitaan, xanjo ama waxyaabaha tubaakada ugu yaraan 30 daqiiqo ka hor inta aan la ururin.
Isticmaal tuubada ururinta iyo candhuufta ururiyaha si aad u ururiso candhuufta.Geli candhuufta ururiyaha tuubada ururinta, ka dibna ku rid candhuufta ururiyaha meel u dhow faruuryaha oo u daa in ay candhuuftu ku shubto tuubada ururinta.Cabbirka candhuufta wuxuu u baahan yahay inuu ahaado qiyaasta cabbirka (qiyaastii.300|jL).Haddii mugga candhuufta uu aad u badan yahay, isticmaal dhibco si aad uga saarto candhuufta xad-dhaafka ah ilaa xalka ugu dambeeya ee calaamadda cabbirka (qiyaastii 300pL).[Isticmaalka loogu talagalay]
Cassette-ka Antigen-ka ee degdegga ah ee COVID-19 (Saliva) waa tallaal-socodka dabadeed ee loogu talagalay in lagu ogaado tayada SARS-CoV-2 nucleocapsid antigens ee candhuufta laga helo shakhsiyaadka looga shakisan yahay COVID-19 bixiyehooda daryeel caafimaad.
Natiijooyinka waa aqoonsiga SARS-CoV-2 nucleocapsid antigen.Antigen-ka guud ahaan waxaa lagu ogaan karaa candhuufta 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.
Cassette-ka Antigen ee Degdegga ah ee Tijaabada (Saliva) ee COVID-19 waxaa loogu talagalay inay adeegsadaan xirfadlayaal caafimaad ama hawl-wadeenno tababaran kuwaas oo si fiican u yaqaanna samaynta tijaabooyinka socodka dambe.Alaabta waxaa loo isticmaali karaa shaybaadh kasta iyo deegaan aan shaybaadhka ahayn oo buuxiya shuruudaha lagu qeexay Tilmaamaha Isticmaalka iyo qawaaniinta deegaanka.
[kooban]
Fayraska novel coronaviruses (SARS-CoV-2) ayaa iska leh p genus.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.
[PRINCIPLE]
Kaassette-ka Antigen-ka ee degdegga ah ee COVID-19 (Saliva) waa tallaal-socodka dabadeed ee ku salaysan mabda'a farsamada sandwich-ka-labba-ilaaliye.SARS-CoV-2 nucleocapsid borotiinka monoclonal antibody oo ay weheliyaan unugyo yaryar 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 capillary ilaa khadka 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 TIRADARO]
• Isticmaalka ogaanshaha in vitro ee kaliya.
• Xirfadlayaasha daryeelka caafimaadka iyo shakhsiyaadka loo tababaray goobaha daryeelka.
• Ha u isticmaalin badeecadan sida saldhigga keliya si aad u baadho ama uga saarto
Infekshanka SARS-CoV-2 ama in lagu wargeliyo heerka caabuqa COVID-19.
Ha isticmaalin alaabtan ka dib taariikhda dhicitaanka.
Fadlan akhri dhammaan macluumaadka ku jira buug-yarahaan ka hor intaadan samaynin baaritaanka.
• 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.
• Cajaladda tijaabada ah ee la isticmaalay waa in la tuuraa si waafaqsan shuruucda federaalka, gobolka iyo deegaanka.
[COMPOSITION]
Agabka la bixiyay
• Tijaabi cajaladaha: cajalad kasta oo ay ku jiraan qalabka wax lagu dhaqo ee ku jira shandad bireed oo gaar ah
• Reagents soo saarista: ampoule ka kooban 0.3 ml oo ah reagent soo saarista
• Candhuufta ururisa
• Tuubooyinka aruurinta
•Dhibaatooyinka
Gelida xirmada
Alaabta loo baahan yahay laakiin lama bixiyo
•Waqti-saare
[KAYDKA IYO XASAANADA]
• Ku kaydi sida baakadeysan ee boorsada xiran heerkulka (4-30°C ama 40-86T).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.
LOT iyo taariikhda dhicitaanka ayaa lagu daabacay calaamadda.
[Ururinta iyo DIYAARINTA NOOSKA AH]
Ha gelin wax afka ah oo ay ku jiraan cunto, cabbitaan, xanjo ama waxyaabaha tubaakada ugu yaraan 30 daqiiqo ka hor inta aan la ururin.
Isticmaal tuubada ururinta iyo candhuufta ururiyaha si aad u ururiso candhuufta.Geli candhuufta ururiyaha tuubada ururinta, ka dibna ku rid candhuufta ururiyaha meel u dhow faruuryaha oo u daa in ay candhuuftu ku shubto tuubada ururinta.Cabbirka candhuufta wuxuu u baahan yahay inuu ahaado qiyaasta cabbirka (qiyaastii.300|jL).Haddii mugga candhuufta uu aad u badan yahay, isticmaal dhibco si aad uga saarto candhuufta xad-dhaafka ah ilaa xalka ugu dambeeya ee calaamadda cabbirka (qiyaastii 300pL).

Gaadiidka Tunyarada iyo Kaydinta

Muunada cusub ee la ururiyey waa in la farsameeyaa sida ugu dhakhsaha badan, laakiin ugu dambayn hal saac ka dib ururinta muunada.

[Habka tijaabada]

Fiiro gaar ah: U ogolow cajaladaha tijaabada, reagents iyo shaybaarada inay u dhigmaan heerkulka qolka (15-30°C ama 59-86T) kahor tijaabada.

Ku rid tuubada ururinta candhuufta ururiyaha kaas oo leh dhareerka gudaha goobta shaqada.Ka fur daboolka reagenaha soo saaristaKu dar dhammaan reajentiyeyaasha soo saarista tuubada ururinta.

Iska tuur candhuufta ururiyaha;Ku dabool tuubada aruurinta caarada dhibcaha ee tuubada aruurinta.U rux tuubada ururinta in ka badan saddex jeer si xoog leh si aad isugu qasto candhuufta iyo reagent soo saarista, ka dibna tuuji xalka isku qasan toban jeer si aad u ogolaato in candhuufta si fiican loo qaso.

Ka saar cajaladda tijaabada bacda xidhan.

U rog tubbada aruurinta, adigoo tuubada si toosan u qabo, ku wareeji 3 dhibcood (qiyaastii 100pL) si tartiib ah muunada si fiican (S) ee cajaladda tijaabada, ka dibna billow saacadda.

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

[ FARSAMADA NATIIJADA]
Wanagsan \|	§	Laba xariiq ayaa soo muuqda.Hal xariiq midab leh ayaa ka muuqda H c ee gobolka kantaroolka (C), iyo mid kale oo Jt\|jne wuxuu ka muuqdaa gobolka tijaabada (T), iyadoon loo eegin xoojinta xariiqda imtixaanka.
xun		Hal xariiq oo midab leh ayaa ka muuqda gobolka kantaroolka (C), mana jiro khad ka muuqda gobolka tijaabada (T).
Aan sax ahayn		Khadka kantaroolku wuu soo bixi waayayKu filnayn,mugga muunada ama habraaca khaldan ee 5 farsamooyinka ayaa ah sababaha ugu badan ee khadadka xakamaynta c.Dib u eeg nidaamka iyo Jtku celi tijaabada adoo isticmaalaya cajalad cusub oo tijaabo ah.HadiiJ)dhibaatadu waa ay sii socotaa, jooji isticmalka faraha isla markiiba oo la xidhiidh qaybiyaha deegaankaaga.

[Kontarool tayo leh]

Xakamaynta habraaca ayaa ku jirta imtixaanka.Xariiq midab leh oo ka soo muuqda gobolka kantaroolka (C) ayaa loo tixgaliyaa kontoroolka habraaca gudaha.Waxay xaqiijisaa mugga muunada ku filan, xuubka xuubka ku filan iyo farsamada habraaca saxda ah.

Heerarka xakamaynta lama bixinin qalabkan.Si kastaba ha ahaatee, waxaa lagu talinayaa in kontaroolada togan iyo kuwa xunba la tijaabiyo inay yihiin dhaqan shaybaar oo wanaagsan si loo xaqiijiyo nidaamka tijaabada iyo in si dhab ah loo tijaabiyo waxqabadka saxda ah.

[LIMITATIONS]

Alaabta ayaa ku xaddidan inay bixiso ogaanshaha tayada leh.Xoojinta xariiqda imtixaanku qasab kuma xidhna fiirsashada antigen-ka shaybaarada.
Natiijooyinka taban kama reebayaan infekshanka SARS-CoV-2 waana inaan loo isticmaalin saldhigga keliya ee go'aannada maaraynta bukaanka.
Dhakhtarku waa inuu u tarjumaa natiijada iyadoo la socota taariikhda bukaanka, natiijooyinka jireed, iyo hababka kale ee ogaanshaha.
Natiijo taban ayaa dhici karta haddii tirada antigens SARS-CoV-2 ee ku jirta muunada ay ka hooseyso heerka la ogaanayo ee baaritaanka, ama fayrasku uu ku dhacay isbeddello yar oo amino acid ah oo ku yaal gobolka bartilmaameedka ah ee loo aqoonsaday unugyada unugyada monoclonal. laga faa'iidaysto imtixaanka.

[SIFAACA WAXQABADKA]

Waxqabadka Caafimaadka

Waxqabadka caafimaad ee COVID-19 Antigen Rapid Test Cassette (Saliva) waxaa lagu aasaasay daraasado mustaqbalka ah oo muunado laga soo ururiyay 628 bukaan oo astaamo leh (7 maalmood gudahooda ee bilawga) iyo bukaannada asymptomatic ee looga shakisan yahay COVID-19.

Xogta kooban ee baaritaanka degdega ah ee COVID-19 Antigen-ka sida hoose:

Meesha wareegga RT-PCR (Ct) waa qiimaha calaamada khuseeya.Qiimaha Ct hoose wuxuu muujinayaa culeyska fayraska oo sarreeya.Dareenka waxaa loo xisaabiyay kala duwanaanshaha qiimaha Ct (Ct valueW37)

Caabuqa COVID-19		RT-PCR		Wadarta
Caabuqa COVID-19		Positivo	Negativo	Wadarta
HEO®	Positivo	172	0	172
HEO®	Negativo	3	453	456
Wadarta		175	453	628

Heshiiska boqolkiiba togan (PPA)=98.28%(172/175),(95%CI:95.08%~99.41%)

Heshiiska Boqolkiiba Xun (NPA)=100%(453/453),(95%CI:99.15%~100%)

PPA - Heshiiska boqolkiiba togan (Xasaasi)

NPA - Heshiiska Boqolkiiba Xun (Qaar)

Xadka ogaanshaha (Dareenka Falanqaynta)

Daraasadu waxay adeegsatay fayraska SARS-CoV-2 ee dhaqanka ah (Go'doomin Hong Kong/ VM20001061/2020, NR-52282), kaas oo ah kulayl aan firfircoonayn oo lagu soo shubay candhuufta.Xadka ogaanshaha (LoD) waa 8.6 X10²TCIDso/ml

Falcelinta isdhaafka ah (Taarikhda Falanqaynta)

Falcelinta isdhaafka ah ayaa lagu qiimeeyay iyadoo la tijaabiyay 32 noole yar yar oo faa'iido leh oo laga yaabo inay ku jiraan afka afka.

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

Wax falcelin isdhaafsi ah laguma arag fayrasyada soo socda markii la tijaabiyay qiyaasta 1.0x10⁶PFU/ml: Hargabka A (H1N1), Hargab A

(H1N1 pdm09), Hargab A(H3N2), Hargabka B (Yamagata), Hargabka B (Victoria), Adenovirus (nooca 1, 2, 3, 5, 7, 55), Metapneumovirus aadanaha, Parainfluenza virus (nooca 1,2, 3, 4), Fayraska syncytial hab-mareenka, Enterovirus, Rhinovirus, coronavirus Human 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

Wax falcelin iskutallaab ah laguma arag bakteeriyada soo socota marka la tijaabiyo fiirsashada 1.0x10'CFU/mL: Mycoplasma pneumoniae, Chlamy dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (koox A), Streptoubicccus pneumoniae. aureus.

Faragelin

Maaddooyinka soo socda ee dhexgalka ee suurtagalka ah ayaa lagu qiimeeyay COVID-19 Antigen Degdegga Kaaska (Saliva) ee uruurinta hoos ku taxan waxaana la ogaaday inaysan saameyn ku yeelan waxqabadka tegt.

Walaxda	Xoog-saarid	Walaxda	Xoog-saarid
Mucin	2%	Dhiig dhan	4%
Benzocaine	5 mg/ml	Menthol	10 mg/ml
Saliidda sanka lagu buufiyo	15%	Phenylephrine	15%
Oxymetazoline	15%	Histamine dihydrochloride	10 mg/ml
Tobramycin	5 pg/ml	Mupirocin	10 mg/ml
Oseltamivir phosphate	10 mg/ml	Zanamivir	5 mg/ml
Arbidol	5 mg/ml	Ribavirin	5 mg/ml
Fluticasone propionate	5%	Dexamethasone	5 mg/ml
Triamcinolone	10 mg/ml

Saamaynta Hook-qaadka sare

Kaassette-ka Antigen-ka ee degdegga ah ee COVID-19 (Saliva) ayaa la tijaabiyay ilaa 1.15x1 o' TCIDso/mL ee SARS-CoV-2 aan firfircoonayn oo wax saameyn ah oo qiyaasta sare ah lama arag.

Hal qayb oo ka mid ah Hangzhou Heo Technology Co., Ltd.

Cinwaanka:Qol201, Dhismaha3, No.2073 Jinchang Road,

Jidka Liangzhu, Degmada Yuhang, Hangzhou, Shiinaha Boostada Boostada：311113

Tel:0086-571-87352763 E-mail:52558565@qq.com

Lotus NL BV Cinwaanka:Koningin Julianaplein 10, le Verd,

2595AA, The Hague, Netherlands.Iimayl:Peter@lotusnl.com

Tel:+31644168999

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.

FARSAMADA NATIIJADA

Wanagsan

C T

Laba xariiq ayaa soo muuqda.Hal xariiq oo midab leh ayaa ka muuqda xoojinta khadka tijaabada.

xun

Hal xariiq oo midab leh ayaa ka muuqda gobolka kantaroolka (C), mana jiro khad ka muuqda gobolka tijaabada (T).

Aan sax ahayn

C T

Xakamaynta line fashilanto to muuqda. Mugga muunada oo aan ku filnayn ama farsamooyinka habraaca khaldan ayaa ah sababaha ugu badan ee keenaya fashilka khadka.Dib u eeg nidaamka oo ku celi tijaabada adoo isticmaalaya cajalad cusub.Haddii dhibaatadu sii socoto, jooji isticmaalka faraha isla markiiba oo la xiriir qaybiyaha deegaankaaga.

Kontaroolka tayada

Heerarka xakamaynta lama bixinin qalabkan.Si kastaba ha ahaatee, waxaa lagu talinayaa in kontaroolada togan iyo kuwa xunba la tijaabiyo sida dhaqanka shaybaadhka wanaagsan si loo xaqiijiyo nidaamka tijaabada iyo si loo xaqiijiyo waxqabadka saxda ah ee imtixaanka.

XADKA

• Alaabta ayaa ku xaddidan inay bixiso ogaanshaha tayada leh.Xoojinta xariiqda imtixaanku qasab kuma xidhna fiirsashada antigen-ka shaybaarada.

Natiijooyinka xun kama hor istaagayaan infekshanka SARS-CoV-2 oo haddii calaamaduhu ay jiraan waa inaad si degdeg ah u raadisaa baaritaan dheeraad ah iyadoo loo marayo Habka PCR.

•Takhtarku waa inuu u tarjumaa natiijada iyadoo la socota taariikhda bukaanka, natiijooyinka jireed, iyo hababka kale ee ogaanshaha.

•Natiijo taban oo laga helay Qalabkan waa in ay xaqiijisaa PCR.Natiijo taban ayaa dhici karta haddii tirada antigens SARS-CoV-2 ee ku jirta muunada ay ka hooseyso heerka la ogaanayo ee baaritaanka, ama fayrasku uu ku dhacay isbeddello yar oo amino acid ah oo ku yaal gobolka bartilmaameedka ah ee loo aqoonsaday unugyada unugyada monoclonal. laga faa'iidaysto imtixaanka.

•Dhiigga xad-dhaafka ah ama xababka ku jira shaybaarka suufka ayaa laga yaabaa inay farageliyaan waxqabadka waxayna keeni karaan natiijo been abuur ah.

Tilmaamaha Waxqabadka

Waxqabadka Caafimaadka

COVID-19 antigen		RT-PCR		Wadarta
COVID-19 antigen		Wanagsan	xun	Wadarta
HEO®	Wanagsan	212	0	212
HEO®	xun	3	569	572
Wadarta		215	569	784

PPA =98.60% (212/215), (95%CI: 95.68%~99.71%) NPA =100% (569/569), (95%CI: 99.47%~100%)

PPA-Heshiiska Boqolkiiba Togan (Xasaasi) NPA-Heshiiska Boqolkiiba Xun (gaar ahaan) 95%

Maalmo laga soo bilaabo calaamadaha	RT-PCR	HEO TECHNOLOGY	Heshiis (%)
0-3	95	92	96.84%
4-7	120	120	100%

Qiimaha CT	RT-PCR	HEO TECHNOLOGY	Heshiis (%)
Ct≤30	42	42	100%
Ct≤32	78	78	100%
Ct≤35	86	85	98.84%
37	9	7	77.78%

Xadka ogaanshaha (Dareenka Falanqaynta)

Daraasadu waxay adeegsatay fayraska SARS-CoV-2, kaas oo kulaylka aan firfircoonayn oo lagu shubay muunada suufka sanka.Xadka ogaanshaha (LoD) waa 1.0 ×102 TCID50/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 fiirsashada 1.0 × 106 PFU/mL: Hargab A (H1N1), Hargab A (H1N1pdm09), Hargab A (H7N9), Hargab A (H3N2), Hargabka 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 markii lagu tijaabiyay fiirsashada 1.0 × 107 CFU/mL: Mycoplasma pneumoniae, Chlamy-dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococ-cus pyogenes (koox A), streptococcus albicans 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.

Walaxda	Xoog-saarid	Walaxda	Xoog-saarid
Mucin	2%	Dhiig dhan	4%
Benzocaine	5 mg/ml	Menthol	10 mg/ml
Saliidda sanka lagu buufiyo	15%	Phenylephrine	15%
Oxymetazoline	15%	Mupirocin	10 mg/ml
Tobramycin	5 μg/ml	Zanamivir	5 mg/ml
Oseltamivir phosphate	10 mg/ml	Ribavirin	5 mg/ml
Arbidol	5 mg/ml	Dexamethasone	5 mg/ml
Fluticasone propionate	5%	Histamiin dihydrochloride	10 mg/ml
Triamcinolone	10 mg/ml	Histamiin dihydrochloride	10 mg/ml

Saamaynta Hook-qaadka sare

Cassette-ka Antigen-ka ee degdegga ah ee COVID-19 (Dahab Colloidal) ayaa la tijaabiyay ilaa 1.0×10 5 TCID50/mL ee SARS-CoV-2 aan firfircoonayn oo wax saameyn ah oo qiyaas sare ah laguma arag.

Su'aasha Inta Badan La Isweydiiyo

1.Sidee u shaqeysaa SARS-CoV-2 Antigen Rapid Test?Tijaabada waxa loogu talagalay in lagu ogaado tayada SARS-CoV-2 antigens ee muunado suuf ah oo iskood isu ururiyey.Natiijadu waxay muujinaysaa SARS-CoV-2 antigens inay ku jiraan muunada.

Goorma ayay tahay in la isticmaalo baaritaanka?

SARS-CoV-2 antigen waxaa lagu ogaan karaa caabuqa ba'an ee neef-mareenka, waxaa lagu talinayaa in la sameeyo baaritaanka marka calaamadaha ay ku jiraan si lama filaan ah ugu yaraan mid ka mid ah kuwan soo socda: qufac, qandho, neefta oo yaraata, daal, rabitaanka cuntada oo yaraada, myalgia.

Natiijadu ma noqon kartaa mid khaldan?

Natiijadu waa sax ilaa iyo inta tilmaamaha si taxadar leh loo ixtiraamo.Si kastaba ha ahaatee, natiijadu waxay noqon kartaa khalad haddii mugga muunad ku filnayn ama SARS-CoV-2 Antigen Rapid Test uu qoyo ka hor inta aan la tijaabin, ama haddii tirada dhibcaha soosaarku ay ka yar yihiin 3 ama in ka badan 4. Ka sokow, sababtoo ah mabaadi'da difaaca jirka. ku lug leh, waxaa jira fursadaha natiijooyin been ah xaalado dhif ah.La talinta dhakhtarka ayaa had iyo jeer lagula taliyaa shaybaarada noocaas ah oo ku saleysan mabaadi'da difaaca jirka.

Sidee loo fasiraa imtixaanka haddii midabka iyo xoojinta xariiqdu ay kala duwan yihiin?Midabka iyo xoojinta xadadka wax muhiimad ah uma laha turjumaada natiijada.Xariiqyadu waa inay ahaadaan kuwo isku mid ah oo si cad loo arki karo.Imtixaanka waa in loo tixgeliyo mid togan si kasta oo uu yahay xoojinta midabka khadka tijaabada.5. Maxaan sameeyaa haddii natiijadu xun tahay?

Natiijada taban waxay ka dhigan tahay inaad taban tahay ama in culeyska fayraska uu aad u hooseeyo

si loo aqoonsado imtixaanku.Si kastaba ha ahaatee, waxaa suurtogal ah in baaritaankani uu keeno natiijo taban oo khaldan (wax taban oo been ah) dadka qaarkiis ee qaba COVID-19.Tani waxay la macno tahay in laga yaabo inaad weli qabtid COVID-19 inkasta oo baaristu uu xun yahay.

Haddii aad isku aragto calaamado ay ka mid yihiin madax-xanuun, madax-xanuun, qandho, luminta dareenka urta iyo dhadhanka, la xiriir xarunta caafimaadka ee kuugu dhow adiga oo isticmaalaya shuruucda maamulka deegaankaaga.Intaa waxaa dheer, waxaad ku celin kartaa tijaabada qalab cusub.Haddii laga shakiyo, ku celi baaritaanka 1-2 maalmood ka dib, maadaama coronavirus-ka aan si sax ah loogu ogaan karin dhammaan wejiyada caabuqa.Xeerarka fogaanta iyo nadaafadda waa in wali la ilaaliyaa.Xitaa haddii natiijada baaritaanka xun ay jirto, masaafada iyo xeerarka nadaafadda waa in la ilaaliyaa, socdaalka/safarka, ka qeybgalka munaasabadaha iyo iwm. waa in ay raacaan tilmaamaha/shuruudaha COVID ee deegaankaaga.6. Maxaan sameeyaa haddii natiijadu noqoto mid wanaagsan?

Natiijada togan waxay ka dhigan tahay joogitaanka antigens SARS-CoV-2.Natiijooyinka togan waxay ka dhigan tahay inay aad ugu badan tahay inaad qabtid COVID-19.Isla markiiba u bax gooni-gooni sida waafaqsan tilmaamaha deegaanka oo isla markiiba la xiriir dhakhtarkaaga guud / dhakhtarkaaga ama waaxda caafimaadka deegaanka sida waafaqsan tilmaamaha maamulka deegaankaaga.Natiijada baaritaankaada waxaa hubin doona baaritaanka PCR waxaana lagu sharixi doonaa talaabooyinka xiga.