I-SARS-CoV-2 Antigen Assay Kit (Indlela ye-Immunochromatography)
SARS-CoV-2 Antigen Assay Kit
(Immunochromatography Method) Product Manual
【PI-RODUCT NAME】SARS-CoV-2 Antigen Assay Kit(Indlela ye-Immunochromatography)
【PACKAGING SPECIFICATIONS】1 Uvavanyo / Ikhithi
【ABSIPHEPHA】
Inoveli coronaviruses yeyodidi lwe-β. I-COVID-19 sisifo esosulelayo esinamandla sokuphefumla. Ngokuqhelekileyo abantu basengozini. Okwangoku, izigulana ezosulelwe yinoveli coronavirus ngoyena mthombo wosulelo; abantu abosulelekileyo abangenazimpawu nabo banokuba ngumthombo wosulelo. Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufukamela yi-1 ukuya kwiintsuku ze-14, ubukhulu becala iintsuku ezi-3 ukuya kwezi-7. Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhwehlela okomileyo. Ukuxinana kweempumlo, impumlo evuzayo, umqala obuhlungu, i-myalgia kunye ne-diarrhea zifumaneka kwiimeko ezimbalwa.
【EXPECTED USAGE】
Le khithi isetyenziselwa ukufumanisa ngokusemgangathweni inoveli coronaviruses (SARS-CoV-2) antigen kwiisampulu zamathe omntu kwi-vitro. Ilungele kuphela ukuxilongwa kwe-in vitro yobungcali, kungekhona ukusetyenziswa komntu.
Le mveliso isetyenziswa kuphela kwiilabhoratri zeklinikhi okanye uvavanyo olukhawulezileyo ngabasebenzi bezonyango. Ayinakusetyenziselwa uvavanyo lwasekhaya.
Ayinakusetyenziswa njengesiseko soxilongo kunye nokukhutshelwa ngaphandle kwenyumoniya ebangelwa lusulelo lwenoveli ye-coronavirus (SARS-CoV-2). Ayifanelekanga ukuba ihlolwe ngabantu ngokubanzi.
Iziphumo zovavanyo lwe-positive zifuna uqinisekiso olungaphaya, kwaye iziphumo zovavanyo olubi azikwazi kuthintela ukosuleleka.
【PRINCIPLES OF THE PI-ROCEI-DURE】
Le mveliso ithatha itekhnoloji ye-colloidal yegolide ye-immunochromatography, ukutshiza igolide ye-colloidal ebhalwe SARS-CoV-2 mono-clonal antibody 1 kwi-pad yegolide I-SARS-CoV-2 monoclonal antibody 2 igqunywe kwi-nitrocellulose membrane njengomgca wovavanyo (umgca we-T) kunye nebhokhwe. I-anti-mouse ye-IgG ye-antibody ifakwe njengomgca wokulawula umgangatho (umgca we-C). Xa isixa esifanelekileyo sesampulu esiza kuvavanywa sidityaniswe kwisampulu yomngxuma wekhadi lovavanyo, isampuli iya kuqhubela phambili ecaleni kwekhadi lovavanyo phantsi kwesenzo se-capillary. Ukuba isampulu iqulethe i-antigen ye-SARS-CoV-2, i-antigen iya kuzibophelela ngegolide ye-colloidal ebhalwe SARS-CoV-2 monoclonal antibody 1, kwaye i-immune complex yenze i-complex ene-SARS-CoV-2 monoclonal antibody 2 egqunyiweyo. Umgca we-T, obonisa umgca we-T omfusa-bomvu, obonisa ukuba i-antigen ye-SARS-CoV-2 ilungile. Ukuba umgca wovavanyo T awubonisi umbala kwaye ubonisa iziphumo ezingalunganga, oko kuthetha ukuba isampuli ayinayo i-antigen ye-SARS-CoV-2. Ikhadi lokuvavanya liqulethe umgca wokulawula umgangatho we-C, kungakhathaliseki ukuba kukho umgca wokuvavanya, umgca wokulawula umgangatho obomvu-obomvu kufuneka uvele. Ukuba umgca wokulawula umgangatho we-C awubonakali, kubonisa ukuba umphumo wokuvavanya awuvumelekanga, kwaye le sampuli kufuneka ihlolwe kwakhona.
【MAIN COMPONENTS】
( 1) Ikhadi lovavanyo.
(2) Incwadana.
Qaphela: Amalungu kwiibhetshi ezahlukeneyo zeekhithi akanakusetyenziswa ngokutshintshanayo.
| Cat. No. | YXN-SARS-AT-01 |
| Package Specifications | 1Test/Kit |
| Ikhasethi yovavanyo | Uvavanyo olu-1* Ipakethi e-1 |
| Imanyuwali | Iqhekeza eli-1 |
【STORAGE AND EXPIRATION】
Ixesha lokuqinisekisa ziinyanga ezili-18 ukuba le mveliso igcinwe kwindawo eyi-2℃-30℃.
Imveliso kufuneka isetyenziswe ngaphakathi kwemizuzu eyi-15 emva kokuba isikhwama se-foil sivulwe.Ukugubungela isiciko ngokukhawuleza emva kokuthatha isisombululo sokukhutshwa kwesampuli. Umhla wemveliso kunye nomhla wokuphelelwa kwexesha ziphawulwe kwileyibhile.
【SAMPLE REQUIREMENTS】
1. Isebenza kwi-swabs yempumlo yomqala, i-oral swabs, isampuli yamathe.
2. Ukuqokelela isampulu:
( 1) Ukuqokelela amathe (YXN-SARS-AT-01): Yenza ucoceko lwezandla ngesepha kunye namanzi / i-alcohol-based rub yesandla. Vula isitya. Yenza ingxolo yeKruuua' emqaleni ukususa amathe kumqala onzulu, emva koko utshice amathe (malunga ne-2 ml) kwisikhongozeli. Kuthintele nakuphi na ukungcoliseka kwamathe kumphezulu ongaphandle wesikhongozeli. Ixesha elilelona lifanelekileyo lokuqokelelwa komfanekiso: Emva kokuvuka nangaphambi kokuxukuxa amazinyo, ukutya okanye ukusela.
3. Yenza isampuli ngokukhawuleza kunye nesisombululo sokutsalwa kwesampula esinikezelwe kwikiti emva kokuba isampuli iqokelelwe. Ukuba ayinakucutshungulwa ngokukhawuleza, isampuli kufuneka igcinwe kwityhubhu yeplastiki eyomileyo, inzalo kwaye ivalwe ngokungqongqo. Iyakwazi ukugcinwa kwi-2℃ -8 ℃ kwiiyure ze-8, kwaye inokugcinwa ixesha elide kwi -70 ℃.
4. Iisampulu ezingcoliseke kakhulu ziintsalela zokutya ngomlomo azinakusetyenziselwa uvavanyo lwale mveliso. Iisampulu eziqokelelwe kwi-swabs ebonakala kakhulu okanye i-agglomerated ayikhuthazwa ukuba kuhlolwe le mveliso. Ukuba i-swabs ihlanjululwe ngexabiso elikhulu legazi, ayikhuthazwa ukuba ihlolwe. Akukhuthazwa ukusebenzisa iisampulu ezicutshungulwayo kunye nesisombululo sokutsalwa kwesampulu esingabonelelwanga kule khithi yokuvavanya le mveliso.
【TESTING METHOD】
Nceda ufunde incwadana yemiyalelo ngononophelo phambi kovavanyo. Nceda ubuyisele zonke iirejenti kwiqondo lobushushu begumbi phambi kovavanyo. Uvavanyo kufuneka lwenziwe kwiqondo lokushisa.
Amanyathelo ovavanyo:
1.Isampulu yamathe(YXN-SARS-AT-01):
( 1) Emva kokuba ikhasethi yovavanyo ibuyele kwiqondo lobushushu begumbi, vula ingxowa yefoyile yealuminiyam kwaye ukhuphe ikhasethi yovavanyo kwaye uyibeke ngokuthe tye kwidesktop.
(2) Susa incam yekhasethi yovavanyo, ntywilisela intonga yekhasethi yovavanyo ematheni, okanye ubeke intonga yekhasethi yovavanyo ngaphantsi kolwimi imizuzu emi-2.
(3) Gcina ikhasethi yovavanyo ime nkqo kwaye uyeke ulwelo lwamathe lunyuke lude lufike okanye luhambe phezu komgca C, emva koko ubuyisele isiciko uze ubeke ikhasethi yovavanyo phezu kwedesika.
(4) Funda iziphumo ezibonisiweyo kwimizuzu eyi-15-30, kwaye iziphumo ezifundwe emva kwemizuzu engama-30 azivumelekanga.
【[INTERPRETATION OF TEST RESULTS】
| ★Zombini umgca wovavanyo (T) kunye nomgca wolawulo (C) zibonisa iibhendi zemibala njengoko umfanekiso ubonisa ngokufanelekileyo, ebonisa ukuba i-antigen ye-SARS-CoV-2 ilungile. | |
| ★ OKUNGABIYO: Ukuba kuphela umgca wokulawula umgangatho we-C uphuhlisa umbala kwaye umgca wokuvavanya (T) awuphuhlisi umbala, i-antigen ye-SARSCoV-2 ayibonakali kwaye isiphumo sibi, njengoko umfanekiso ubonisa ngokufanelekileyo. | |
| ★OKUNGENAKUMBI: Akukho bhanti yombala ibonakala kumgca wokulawula umgangatho (C), kwaye igwetywa njengesiphumo esingasebenziyo nokuba umgca wobhaqo (T) ubonisa ibhendi yombala okanye hayi, njengoko umfanekiso ubonisa njengokulungileyo.Umgca wolawulo uyasilela ukuvela.Umthamo wesampulu engonelanga okanye ubuchule benkqubo obungachanekanga zezona zizathu zinokwenzeka zokungaphumeleli komgca wolawulo.Jonga kwakhona inkqubo kwaye uphinde uvavanyo ngekhasethi entsha yovavanyo.Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa ikiti yovavanyo kwangoko kwaye uqhagamshelane nomthengisi wendawo yakho. |
【LIMITATION OF FUMANAION METHOD】
1. Ukuqinisekiswa kweklinikhi
Ukuze kuvavanywe ukusebenza koxilongo, olu phononongo lusebenzise iisampulu ezine-COVID-19 kubantu abayi-150 kunye ne-COVID-19-abangenayo i-COVID-19 kubantu abangama-350. Le mizekelo yavavanywa kwaye yaqinisekiswa yindlela ye-RT-PCR. Iziphumo zezi zilandelayo:
a) Uvakalelo :92.67% (139/ 150), 95%CI (87.26%, 96.28%).
b) Ukuchaza ngokuthe ngqo: 98.29% ( 344/350), 95% CI ( 96.31%, 99.37%).
2. Ubuncinci bomda wokubona:
Xa umxholo wentsholongwane ungaphezu kwe-400TCID50 / ml, izinga lokufumanisa okulungileyo likhulu kune-95%. Xa umxholo wentsholongwane ungaphantsi kwe-200TCID50 / ml, izinga lokufumanisa okulungileyo lingaphantsi kwe-95%, ngoko ke umda omncinci wokufumanisa le mveliso ngu-400TCID50 / ml.
3. Ukuchaneka:
Iibhetshi ezintathu ezilandelelanayo ze-reagents zavavanywa ngokuchanekileyo. Iibhetshi ezahlukeneyo ze-reagents zisetyenziselwe ukuvavanya isampuli efanayo engalunganga ngamaxesha angama-10 ngokulandelelana, kwaye iziphumo zazingalunganga. Iibhetshi ezahlukeneyo ze-reagents zisetyenziselwe ukuvavanya isampuli elungileyo amaxesha angama-10 ngokulandelelana, kunye
zonke iziphumo bezilungile.
4. I-HOOK isiphumo:
Xa umxholo wentsholongwane kwisampulu oza kuvavanywa ufikelela kwi-4.0 * 105TCID50 / ml, umphumo wovavanyo awubonakalisi umphumo we-HOOK. 5. Ukuphambana kwentshukumo
I-Cross-reactivity yeKit iye yavavanywa. Iziphumo zibonise ukuba akukho reactivity emnqamlezweni nalo mzekelo ulandelayo.
| No | Into | Conc | No | Into | Conc |
| 1 | HCOV-HKU1 | 105TCID50/ml | 16 | Umkhuhlane A H3N2 | 105TCID50/ml |
| 2 | Staphylococcus aureus | 106TCID50/ml | 17 | H7N9 | 105TCID50/ml |
| 3 | Iqela A streptococci | 106TCID50/ml | 18 | H5N1 | 105TCID50/ml |
| 4 | Intsholongwane yemasisi | 105TCID50/ml | 19 | Intsholongwane ka-Epstein-Barr | 105TCID50/ml |
| 5 | Intsholongwane kaqwilikana | 105TCID50/ml | 20 | I-Enterovirus CA16 | 105TCID50/ml |
| 6 | Uhlobo lwe-Adenovirus 3 | 105TCID50/ml | 21 | Rhinovirus | 105TCID50/ml |
| 7 | Mycoplasmal pneumonia | 106TCID50/ml | 22 | Intsholongwane ebangela usuleleko lwamalungu okuphefumla | 105TCID50/ml |
| 8 | Intsholongwane yeParaimfluenza, uhlobo2 | 105TCID50/ml | 23 | Streptococcus pneumoniae | 106TCID50/ml |
| 9 | I-metapneumovirus yabantu | 105TCID50/ml | 24 | Candida albicans | 106TCID50/ml |
| 10 | I-coronavirus yabantu OC43 | 105TCID50/ml | 25 | I-Chlamydia pneumoniae | 106TCID50/ml |
| 11 | I-coronavirus yabantu 229E | 105TCID50/ml | 26 | Bordetella pertussis | 106TCID50/ml |
| 12 | I-Bordetella parapertusis | 106TCID50/ml | 27 | Pneumocystis jiroveci | 106TCID50/ml |
| 13 | Umkhuhlane we-B Victoria | 105TCID50/ml | 28 | I-Mycobacterium tubercu ilahleko | 106TCID50/ml |
| 14 | Umkhuhlane we-B Y | 105TCID50/ml | 29 | Legionella pneumophila | 106TCID50/ml |
| 15 | Umkhuhlane A H1N1 2009 | 105TCID50/ml |
6. Izinto eziphazamisayo
Iziphumo zovavanyo aziphazamisi kwi-concentration elandelayo:
| No | Into | Conc | No | Into | Conc |
| 1 | IGazi Elipheleleyo | 4% | 9 | Mucin | 0 50% |
| 2 | Ibuprofen | 1mg/ml | 10 | I-Compound Benzoin Gel | 1.5mg/ml |
| 3 | tetracycline | 3ug/ml | 11 | Cromolyn glycate | 15% |
| 4 | chloramphenicol | 3ug/ml | 12 | I-Deoxyepinephrine hydrochloride | 15% |
| 5 | Erythromycin | 3ug/ml | 13 | Afrin | 15% |
| 6 | Tobramycin | 5% | 14 | Fluticasone propionate spray | 15% |
| 7 | I-Oseltamivir | 5mg/ml | 15 | menthol | 15% |
| 8 | Naphazoline Hydrochlor ukukhwela ngeempumlo Drops | 15% | 16 | Mupirocin | 10mg/ml |
【LIMITATION OF FUMANAION METHOD】
1. Le mveliso inikezelwa kuphela kwiilabhoratri zeklinikhi okanye abasebenzi bezonyango ukuze kuhlolwe ngokukhawuleza, kwaye ayikwazi ukusetyenziselwa uvavanyo lwasekhaya.
2. Le mveliso ifaneleka kuphela ukufunyanwa kwempumlo yomntu okanye iisampuli zokukhupha umqala. Ibona umxholo wentsholongwane kwisicatshulwa sesampulu, kungakhathaliseki ukuba intsholongwane iyosulela. Ke ngoko, iziphumo zovavanyo lwale mveliso kunye neziphumo zenkcubeko yentsholongwane yesampulu efanayo ayinakunxulumana.
3. Ikhadi lokuvavanya kunye nesisombululo sokukhutshwa kwesampuli yale mveliso kufuneka ibuyiselwe kwiqondo lokushisa ngaphambi kokusetyenziswa. Ubushushu obungafanelekanga bunokubangela iziphumo zovavanyo olungaqhelekanga.
4. Ngethuba lenkqubo yokuvavanya, iziphumo zovavanyo zinokuthi zihambelane neziphumo zeklinikhi ngenxa yokungonelanga kwesampuli yokuqokelela i-swabs eyinyumba okanye ukuqokelela okungafanelekanga kunye nokusebenza kwe-specimen extraction.
5. Ngethuba lokusetyenziswa kwale mveliso, kufuneka ulandele ngokuthe ngqo amanyathelo okusebenza kwencwadana. Amanyathelo okusebenza angafanelekanga kunye neemeko zokusingqongileyo zinokubangela iziphumo zovavanyo ezingaqhelekanga.
6. I-swab kufuneka ijikelezwe malunga namaxesha angama-10 kudonga lwangaphakathi lombhobho wokuvavanya oqukethe isisombululo sokukhutshwa kwesampuli. Ukujikeleza okumbalwa kakhulu okanye okuninzi kakhulu kunokubangela iziphumo zovavanyo ezingaqhelekanga.
7. Isiphumo esihle sale mveliso asinakukhupha ithuba lokuba ezinye iintsholongwane zibe zilungile.
8. Iziphumo zovavanyo olubi ukuba le mveliso ayinakukhuphela ngaphandle amathuba okuba ezinye iipathogens zibe positive.
9. Iziphumo zovavanyo olubi zicetyiswa ukuba ziqinisekiswe nge-nucleic acid zokufumanisa i-reagents ukuphepha umngcipheko wovavanyo oluphosiweyo.
10. Kusenokubakho umahluko kwiziphumo zovavanyo phakathi kweisampulu zeklinikhi ezikhenkcezisiweyo kunye neesampulu zeklinikhi ezisanda kuqokelelwa.
11. Lo mzekelo kufuneka uvavanywe ngoko nangoko emva kokuba uqokelelwe ukuthintela iziphumo zovavanyo ezingaqhelekanga emva kokushiywa ixesha elide kakhulu.
12. Ngexesha lokusetyenziswa kwale mveliso, isixa sesampulu esifanelekileyo siyimfuneko, isixa sesampulu esincinci okanye esininzi sinokubangela iziphumo zovavanyo ezingaqhelekanga. Kunconywa ukusebenzisa i-pipette kunye nomthamo wesampulu echanekileyo yovavanyo lokudibanisa isampuli.
【PRECAUTIONS】
1. Nceda ulungelelanise isampuli ye-diluent kunye nekhadi lokuvavanya kwiqondo lokushisa kwegumbi (ngaphezu kwe-30min) ngaphambi kokuvavanya.
2. Ukuhlolwa kufuneka kwenziwe ngokungqinelana nemiyalelo.
3. Isiphumo kufuneka sitolikwe ngaphakathi kwe-15-30min, kwaye umphumo ofundwe emva kwemizuzu engama-30 awuvumelekanga.
4. Isampuli yovavanyo kufuneka ithathwe njengento echaphazelekayo, kwaye umsebenzi kufuneka uqhutywe ngokuhambelana neenkcukacha zokusebenza kwebhubhoratri yesifo esosulelayo, kunye namanyathelo okukhusela kunye nokuqwalaselwa kwi-bio-safety operation.
5. Le mveliso iqulethe izinto eziphuma kwizilwanyana. Nangona ingosuleli, kufuneka iphathwe ngononophelo xa kusingathwa iindawo ezinokuthi zibe khona zosulelo. Abasebenzisi kufuneka bathathe amanyathelo okhuseleko ukuqinisekisa ukhuseleko lwabo kunye nabanye.
6. Amakhadi ovavanyo asetyenzisiweyo, iisampuli zesicatshulwa, njl.njl. ziphathwa njengenkunkuma ye-bio-medical emva kovavanyo, kwaye uhlambe izandla zakho ngexesha.
7. Ukuba isisombululo sonyango lwesampulu sale mveliso sichitheka ngengozi esikhumbeni okanye emehlweni, nceda uhlambe ngokukhawuleza ngamanzi amaninzi, kwaye ufune unyango ukuba kuyimfuneko.
8. Musa ukusebenzisa ikiti ngomonakalo ocacileyo, kunye nekhadi lokuvavanya kunye nephakheji eyonakele.
9. Le mveliso yimveliso yokusetyenziswa kwexesha elinye, nceda ungayisebenzisi kwakhona, kwaye ungasebenzisi iimveliso eziphelelwe lixesha.
10. Gwema ukukhanya kwelanga kunye nokuvuthela ngokuthe ngqo kubalandeli bombane ngexesha lovavanyo.
11. Amanzi ompompo, amanzi adibeneyo okanye amanzi adibeneyo kunye neziselo azikwazi ukusetyenziswa njengezixhobo zokulawula ezingalunganga.
12. Ngenxa yokwahlukana kweesampuli, ezinye iilayini zovavanyo zingaba khaphukhaphu okanye zibe ngwevu ngombala. Njengemveliso esemgangathweni, ngokude nje kukho ibhendi kwindawo yomgca we-T, inokugwetywa njengento enhle.
13. Ukuba uvavanyo lubonisa ukuba unayo, kucetyiswa ukuba usebenzise eli khadi lovavanyo ukuphinda ulitshekishe kube kanye ukuthintela iziganeko ezincinci ezinokwenzeka.
14. Kukho i-desiccant kwisikhwama se-aluminium foil, ungayithathi ngomlomo
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