Ko te Kete Tirohanga Antigen SARS-CoV-2
SARS-CoV-2 Antigen Assay Kit
（Immunochromatography Method) Product Manual
【PRODUCT NAME】Ko te Kete Tirohanga Antigen SARS-CoV-2（Tikanga Immunochromatography)
【PAKEKAING SPECIFICATIONS】1 Whakamātautau/Kete ,25Tests/Kete, 100Tests/Ket
【ABSWHAKAARO】
Ko nga coronaviruses hou no te puninga β. Ko te COVID-19 he mate hopuhopu manawa. He whakaraerae te tangata. I tenei wa, ko nga turoro kua pangia e te coronavirus hou te tino take o te mate; Ko nga tangata kua pangia asymptomatic he puna hopuhopu. I runga i nga rangahau mate urutaru o naianei, ko te wa whakamohoatanga he 1 ki te 14 ra, ko te nuinga 3 ki te 7 ra. Ko nga tohu matua ko te kirikaa, te ngenge me te mare maroke. Ko te ihu o te ihu, te ihu rere, te korokoro, te myalgia me te matere ka kitea i etahi keehi.
【EXPECTED USAGE】
Ka whakamahia tenei kete ki te kimi i nga antigen hou coronaviruses (SARS-CoV-2) i roto i nga ruuma korokoro o te tangata, te korokoro waha, te huware oropharyngeal o muri, te sputum me nga tauira kumete.
He pai anake mo te tātaritanga in vitro ngaio, kaua mo te whakamahi whaiaro.
Ka whakamahia noa tenei hua i roto i nga taiwhanga haumanu, i nga whakamatautau tonu ranei e nga kaimahi hauora. Kaore e taea te whakamahi mo te whakamatautau kaainga.
Kare e taea te whakamahi hei putake mo te tātaritanga me te whakakore i te pneumonia na nga mate coronaviruses hou (SARS-CoV-2). Kaore e pai mo te tirotiro ma te iwi whanui.
Ko te hua whakamatautau pai me whakamanahia ano, a kaore e taea e te hua whakamatautau kino te whakakore i te tupono ka pangia.
Ko te kete me nga hua whakamatautau mo te tohutoro haumanu anake. E taunaki ana kia whakakotahihia nga whakaaturanga haumanu o te manawanui me etahi atu whakamatautau taiwhanga mo te tātaritanga matawhānui o te mate. Kaore e taea e te kete te wehewehe i waenga i te SARS-CoV me te SARS-CoV-2.
【PRINCIPLES OF THE PROCEDURE】
Ko tenei hua ka whakamahi i te hangarau immunochromatography koura colloidal, te rehu koura colloidal kua tapaina he SARS-CoV-2 mono-clonal antibody 1 ki te papa koura Ko te SARS-CoV-2 monoclonal antibody 2 kua pania ki te membrane nitrocellulose hei raina whakamatautau (raina T) me te koati. Ko te antibody IgG anti-kiore kua pania hei raina mana kounga (raina C). Ina taapirihia he rahinga tika o te tauira hei whakamatautau ki te kohao tauira o te kaari whakamatautau, ka neke whakamua te tauira ma te kaari whakamatautau i raro i te mahi kapi. Mena kei roto i te tauira he antigen SARS-CoV-2, ka herea te antigen ki te koura colloidal e tapaina ana ko te SARS-CoV-2 monoclonal antibody 1, a ka hangaia e te matatini parepare he matatini me te whakakikorua o te SARS-CoV-2 monoclonal antibody 2 i te Ko te raina T, e whakaatu ana i te raina T papura-whero, e tohu ana he pai te antigen SARS-CoV-2. Mena kaore te raina whakamatautau T e whakaatu i te tae me te whakaatu he hua kino, ko te tikanga kaore te tauira i roto i te antigen SARS-CoV-2. Kei roto ano i te kaari whakamatautau he raina mana kounga C, ahakoa he raina whakamatautau, me puta te raina mana kounga papura-whero C. Ki te kore e puta te raina mana kounga C, e tohu ana he muhu te hua o te whakamatautau, me whakamatau ano tenei tauira.
【MAIN COMPONENTS】
1.Kari Whakamatau ：Ko te kaari whakamatautau he kaari kirihou me te taakahu whakamatautau. Ko te riipene whakamatautau he mea hanga ki te membrane nitrocellulose (kua whakakikoruatia te waahi kitea ki te SARS-CoV-2 monoclonal antibody 2, ko te waahi whakahaere kounga ka pania ki te koati antimouse IgG antibody), me te papa koura (ka pania ki te koura colloidal kua tapaina he SARS-CoV- 2 monoclonal antibody 1), tauira papa, pepa absorbent, me te papa PVC.
2. Tauira otinga tangohanga: Ko te otinga Buffer kei roto he phosphate e rite ana ki nga whakaritenga o te kete (pH6.5-8.0).
3. Tauira ngongo tangohanga.
4. Mirimiri, pania, ipu.
5. ā-ringa.
Tuhipoka: Ko nga waahanga kei roto i nga huinga rereke o nga kete kaore e taea te whakamahi rereke.
| Cat. No. | YXN-SARS-AT-01 | YXN-SARS-AT-25 | YXN-SARS-AT-100 |
| Package Specifications | 1 test/kit | 25 tests/kit | 100 tests/kit |
| Tauira tangohanga otinga | 1mL/pounamu | 5mL/pounamu*6 ipu | 5mL/ pounamu*24 pounamu |
| Tauira tangohanga ngongo | 1 whakamātautau* 1 mōkihi | ≥25 whakamātautau* 1 mōkihi | ≥25 whakamātautau* 4 mōkihi |
| pukapuka | 1 wahi | 1 wahi | 1 wahi |
【STORAGE ME EXPIKIoreION】
Ko te wa whaimana he 18 marama mena kei te rongoa tenei hua ki te taiao 2 ℃-30 ℃.
Me whakamahi te hua i roto i te 15 meneti i te wa e tuwhera ana te putea konumohe. Kapihia te taupoki i muri tonu i te tango i te otinga tangohanga tauira. Ko te ra whakaputa me te ra paunga ka tohua ki te tapanga.
【SAMPLE REQUIREMENTS】
1. E tika ana ki nga purakau korokoro o te ihu tangata, kikii waha korokoro, huware oropharyngeal o muri, tauira huaka me te kutae.
2. Kohinga tauira:
( 1) Kohinga hunanga nasal: I te wa e kohikohi ana i nga mea huna o te ihu, kuhuhia he mokowhiti ki roto i te waahi e tino kitea ana te hunanga ki roto i te rua o te ihu, ata huri me te pana i te pani ki roto i te rua o te ihu tae noa ki te aukati i te turbinate, ka huri i te kaukau kia toru. nga wa ki te pakitara o te ihu
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ka tango i te kaukau.
(2)Kohinga hunanga korokoro: Whakauruhia he tapahi parakore ki roto i te korokoro mai i te waha, ka aro ki te pakitara korokoro me te waahi whero o nga tonsils parate, horoia nga tonsils pharyngeal rua me te pakitara pharyngeal muri me te kaha ngawari, karohia te pa ki te arero ka tango i te kaukau.
(3) Huware oropharyngeal o muri: Me horoi ringa ki te hopi me te wai / mirimiri ringa-waipiro. Whakatuwheratia te ipu. Haruru Kruuua' mai i te korokoro ki te horoi i te huware i te korokoro hohonu ，ka tuha te huware (e 2 ml) ki roto i te ipu. Me karo i te poke huware o te mata o waho o te ipu. Te wa tino pai mo te kohikohi tauira: I muri i te maranga me i mua i te parai niho, te kai, te inu ranei.
3. Tukatia tonutia te tauira me te otinga tangohanga tauira e whakaratohia ana i roto i te kete i muri i te kohi tauira. Ki te kore e taea te tukatuka tonu, me penapena te tauira ki roto i te ngongo kirihou maroke, kua whakahoroa, kua hiritia. Ka taea te penapena ki te 2 ℃ -8 ℃ mo te 8 haora, ka taea te penapena mo te wa roa ki te -70 ℃.
4. Ko nga tauira kua pokea e te toenga kai waha e kore e taea te whakamahi hei whakamatautau i tenei hua. Ko nga tauira i kohia mai i nga tapahi he tino kakahore, he whakahiato ranei, kaore i te tūtohutia mo te whakamatautau i tenei hua. Mena kua poke nga pania ki te nui o te toto, kaore i te tūtohutia mo te whakamatautau. Kaore i te tūtohutia kia whakamahia nga tauira kua tukatukahia me te otinga tangohanga tauira kaore i whakaratohia ki tenei kete hei whakamatautau i tenei hua.
【TESTING METHOD】
Tena koa panuihia te pukapuka tohutohu i mua i te whakamatautau. Tena koa whakahokia nga reagents katoa ki te pāmahana rūma i mua i te whakamatautau. Me mahi te whakamatautau i te pāmahana rūma.
Nga Mahi Whakamatau:
1. Tauira Tangohanga:
( 1) Huware oropharyngeal muri, tauira sputum: Whakapiri poutū 200ul tauira otinga tangohanga (mo te 6 pata) ki roto i te tauira ngongo tangohanga ka whakawhiti tata ki te 200μL o te huware hou, te sputum ranei mai i te ipu ki roto i te Tauira Tangohanga Tube ka wiri, ka uru katoa.
(2) Tauira Stool: Whakapiri poutū 200ul tauira otinga tangohanga (mo te 6 pata) ki roto i te tauira ngongo tangohanga , whakamahia te rakau tauira ki te tiki tata ki te 30mg o nga tauira kumete hou (E rite ana ki te rahi o te upoko whakataetae). Whakanohoia te rakau tauira ki roto i te Tauira Tangohanga Tube ka wiriwiri, ka uru katoa kia rewa katoa te kumete.
(3) Tauira swabs: Tāpiri poutū 500ul tauira otinga tangohanga (mo te 15 pata) ki te ngongo tango tauira. Whakauruhia te ūkui kua kohia ki roto i te otinga i roto i te tauira ngongo tangohanga, ka huri tata ki te pakitara o roto o te ipuipu whakamatautau kia 10 nga wa kia memeha te tauira i roto i te otinga ka taea. Kohia te pane ūkui o te ūkui ki te taha o te pakitara o roto o te ngongo tangohanga kia mau tonu te wai ki roto i te ngongo ka taea, tango me te ruku i te pani. Hipokina te taupoki.
2. Nga tikanga rapunga:
( 1) I muri i te hokinga o te kaari whakamatautau ki te pāmahana rūma, whakatuwherahia te putea konumohe konumohe ka tangohia te kaari whakamatautau ka tuu whakapae ki runga i te papamahi.
(2) Tāpirihia te 65ul (mo te 2 pata) o te tangohanga tauira kua tukatukahia, ka taapiri tika ranei i te 65ul (mo te 2 pata) o te otinga tauira huaketo kua tukatukahia ki te rua tauira o te kaari whakamatautau.
(3) Panuitia te hua kua whakaatuhia i roto i te 15-30 meneti, ka muhu nga hua ka panui i muri i te 30 meneti.
【IWHAKAMAHIION OF TEST RESULTS】
| ★Ko te raina whakamatautau (T) me te raina whakahaere (C) e whakaatu ana i nga roopu tae e whakaatu ana te pikitia he tika, e tohu ana he pai te antigen SARS-CoV-2. | |
| ★NEGATIVE: Mena ko te raina mana kounga C anake ka whanake te tae, karekau te raina whakamatautau (T) e whanake te tae, karekau te antigen SARSCoV-2 e kitea, he kino te hua, e whakaatu ana te pikitia he tika. | |
| ★KORE MAHI: Karekau he roopu tae ka puta ki te raina mana kounga (C), ka whakatauhia he hua muhu ahakoa te whakaatu mai te raina rapu (T) i te roopu tae, kaore ranei, i te mea e whakaatu ana te pikitia he tika. Karekau te raina whakahaere e puta mai.Ko te kore rawaka o te rahinga tauira, ko nga tikanga whakahaere hē ranei te take mo te korenga o te raina whakahaere.Tirotirohia te tukanga me te whakahoki ano i te whakamatautau me te rīpene whakamatautau hou.Ki te mau tonu te raru, whakamutua te whakamahi i te kete whakamatautau tonu ka whakapā atu ki a koe rohe distributor.Standard Laboratory Practice (GLP) taiwhanga ki te whakahaere i te mana kounga i runga i nga tikanga whakahaere taiwhanga i raro i te arata'iraa a te motu, rohe ranei. |
2
【LIMITATION OF KAUPAPAION METHOD】
1. Manatoko haumanu
Hei arotake i te mahi tātaritanga, i whakamahia e tenei rangahau nga tauira COVID-19-pai mai i te 252 takitahi me nga tauira COVID-19-kino mai i te 686 takitahi. I whakamatauria enei tauira me te whakamanahia e te tikanga RT-PCR. Ko nga hua e whai ake nei:
a) Tairongo: 95.24%(240/252), 95%CI(91.83%, 97.52%)
b) Tauwhāititanga: 99. 13%(680/686), 95%CI(98. 11%, 99.68%)
2. Tetenga kitenga iti:
Ina he nui ake te ihirangi huaketo i te 400TCID50/ml, he nui ake i te 95%. Ina he iti iho te ihirangi huaketo i te 200TCID50/ml, he iti iho i te 95% te reeti kitenga pai, na ko te 400TCID50/ml te tepe rapunga iti o tenei hua.
3. Tika:
E toru nga wahanga karapīpiti o nga reagents i whakamatauria mo te tika. I whakamahia nga roopu rereke o nga reagents ki te whakamatautau i te tauira kino kotahi 10 nga wa i ia tau, a he kino katoa nga hua. I whakamahia nga roopu rereke o nga reagents ki te whakamatautau i te tauira pai rite 10 nga wa i ia tau, a he pai katoa nga hua.
4. Painga HOOK:
Ina tae te ihirangi huaketo i roto i te tauira kia whakamatauria ki te 4.0*105TCID50/ml, kaore tonu te hua o te whakamatautau e whakaatu i te paanga HOOK.
5. Tauhohenga whakawhiti
I arotakea te hohehohenga whakawhiti o te Kete. Ko nga hua kaore he tauhohenga whakawhiti me te tauira e whai ake nei.
| Kao. | Tūemi | Conc. | Kao. | Tūemi | Conc. |
| 1 | HCOV-HKU1 | 105TCID50/ml | 16 | Rewharewha A H3N2 | 105TCID50/ml |
| 2 | Staphylococcus aureus | 106TCID50/ml | 17 | H7N9 | 105TCID50/ml |
| 3 | Rōpū A streptococci | 106TCID50/ml | 18 | H5N1 | 105TCID50/ml |
| 4 | Te mate karawaka | 105TCID50/ml | 19 | Epstein-Barr huaketo | 105TCID50/ml |
| 5 | Te huaketo mumps | 105TCID50/ml | 20 | Enterovirus CA16 | 105TCID50/ml |
| 6 | Adenovirus momo 3 | 105TCID50/ml | 21 | Rhinovirus | 105TCID50/ml |
| 7 | Mycoplasmal pneumonia | 106TCID50/ml | 22 | Respiratory syncytial huaketo | 105TCID50/ml |
| 8 | Paraimfluenzavirus, momo2 | 105TCID50/ml | 23 | Streptococcus pneumoniae | 106TCID50/ml |
| 9 | Metapneumovirus tangata | 105TCID50/ml | 24 | Candida albicans | 106TCID50/ml |
| 10 | Coronavirus tangata OC43 | 105TCID50/ml | 25 | Chlamydia pneumoniae | 106TCID50/ml |
| 11 | Coronavirus tangata 229E | 105TCID50/ml | 26 | Bordetella pertussis | 106TCID50/ml |
| 12 | Bordetella parapertusis | 106TCID50/ml | 27 | Pneumocystis jiroveci | 106TCID50/ml |
| 13 | Rewharewha B Victoria riaka | 105TCID50/ml | 28 | Mycobacterium tubercu ngaro | 106TCID50/ml |
| 14 | Rewharewha B Y riaka | 105TCID50/ml | 29 | Legionella pneumophila | 106TCID50/ml |
| 15 | Rewharewha A H1N1 2009 | 105TCID50/ml |
6. Matū Porearea
Ko nga hua whakamatautau karekau e pokanoa ki te matū i te kukū e whai ake nei:
| Kao. | Tūemi | Conc. | Kao. | Tūemi | Conc. |
| 1 | Toto Katoa | 4% | 9 | Mucin | 0.50% |
| 2 | Ibuprofen | 1mg/ml | 10 | Pūhui Benzoin Gel | 1.5mg/ml |
| 3 | tetracycline | 3ug/ml | 11 | Cromolyn glycate | 15% |
| 4 | chloramphenicol | 3ug/ml | 12 | Deoxyepinephrine hydrochloride | 15% |
| 5 | Erythromycin | 3ug/ml | 13 | Afrin | 15% |
| 6 | Tobramycin | 5% | 14 | Fluticasone propionate rehu | 15% |
| 7 | Oseltamivir | 5mg/ml | 15 | menthol | 15% |
| 8 | Naphazoline Hydrochlo eke Nasal Drops | 15% | 16 | Mupirocin | 10mg/ml |
【LIMITATION OF KAUPAPAION METHOD】
1. Ka tukuna noa tenei hua ki nga taiwhanga haumanu, ki nga kaimahi hauora ranei mo te whakamatautau tonu, kaore e taea te whakamahi mo te whakamatautau i te kainga.
2. He pai noa tenei hua mo te kite i nga tauira o te ihu tangata, o te korokoro ranei. Ka kitea te ihirangi huaketo i roto i te tangohanga tauira,
3
ahakoa he hopuhopu te huaketo. Na reira, ko nga hua whakamatautau o tenei hua me nga hua ahurea huaketo o te tauira kotahi kaore pea e hono.
3. Ko te kaari whakamatautau me te otinga tangohanga tauira o tenei hua me whakahoki ki te pāmahana rūma i mua i te whakamahi. Ko te pamahana he kino ka puta he hua whakamatautau.
4. I te wa o te whakamatautau, kare pea nga hua whakamatautau e rite ki nga hua haumanu na te iti o te kohinga tauira o nga tapahi horomata, he koretake ranei te mahi tangohanga tauira.
5. I te wa e whakamahia ana tenei hua, me tino whai koe i nga waahanga whakahaere o te pukapuka. Ko nga mahi hee me nga ahuatanga o te taiao ka raru pea nga hua whakamatautau.
6. Kia 10 pea te hurihanga o te kaukau ki runga i te pakitara o roto o te ipuipu e mau ana te otinga tangohanga tauira. He iti rawa, he nui rawa ranei nga hurihanga ka puta he hua whakamatautau.
7. Kare e taea e te hua pai o tenei hua te whakakore i te tupono he pai etahi atu tukumate.
8. Ko te hua whakamatautau pai o tenei hua kaore e taea te wehewehe i waenga i te SARS-CoV me te SARS-CoV-2.
9. Ko te hua whakamatautau kino e kore e taea e tenei hua te whakakore i te tupono he pai etahi atu tukumate.
10. Ko nga hua whakamatautau kino e taunaki ana kia manatokohia me nga reagents kimi waikawa karihi hei karo i te tupono ka ngaro te whakamatautau.
11. He rereke pea nga hua whakamatautau i waenga i nga tauira haumanu tio me nga tauira haumanu katahi ano ka kohia.
12. Me whakamatauria te tauira i muri tonu i te kohinga kia kore ai e puta nga hua whakamatautau kino i muri i te wa roa.
13. I te wa e whakamahia ana tenei hua, me tika te rahinga tauira, he iti rawa, he nui rawa ranei te rahinga tauira ka puta he hua whakamatautau. E taunaki ana ki te whakamahi i te pipette me te rahinga tauira tika ake mo te whakamatautau taapiri tauira.
【KAUPAPAIONS】
1. Whakataurite koa te tauira diluent me te kaari whakamatautau ki te pāmahana rūma (i runga ake i te 30min) i mua i te whakamatautau.
2. Ko te tirotiro me tino rite ki nga tohutohu.
3. Me whakamaori te hua i roto i te 15-30min, a ko te hua ka panui i muri i te 30 min ka muhu.
4. Ko te tauira whakamatautau me kiia he matū hopuhopu, me whakahaere te mahi i runga i nga whakaritenga whakahaere o te taiwhanga mate hopuhopu, me nga tikanga whakamarumaru me te aro ki te mahi haumaru-koiora.
5. Kei roto i tenei hua nga matū i ahu mai i te kararehe. Ahakoa ehara i te rewharewha, me tupato ki te whakahaere i nga punawai mate. Me whai nga kaiwhakamahi i nga tikanga whakamarumaru hei whakarite i te haumarutanga o ratou ake me etahi atu.
6. Ko nga kaari whakamatautau kua whakamahia, nga tangohanga tauira, me era atu mea ka kiia he para koiora-hauora i muri i te whakamatautau, me te horoi i o ringaringa i te waa.
7. Mena ka pakaru te tauira otinga maimoatanga o tenei hua ki roto ki te kiri, ki nga kanohi ranei, me horoi tonu ki te wai nui, ka rapua te rongoa mehemea e tika ana.
8. Kaua e whakamahi i te kete ki te kino kitea, me te kāri whakamātautau ki te mōkihi pakaru.
9. Ko tenei hua he hua mo te wa kotahi, kaua e whakamahia ano, kaua hoki e whakamahi i nga hua kua pau.
10. A ape i te ra tika me te pupuhi tika mai i nga pa hiko i te wa o te whakamatautau.
11. Ko te wai tap, te wai parakore, te wai whakaheke ranei me nga inu kaore e taea te whakamahi hei reagents mana kino.
12. Na te rereke o nga tauira, he maama ake pea etahi rarangi whakamatautau, he hina ranei te tae. Hei hua kounga, i te mea he roopu kei te tuunga o te raina T, ka taea te whakatau he pai.
13. Mena he pai te whakamatautau, e taunaki ana kia whakamahia tenei kaari whakamatautau ki te tirotiro ano kia kotahi ki te karo i nga huihuinga iti.
14. He whakamaroke kei roto i te putea konumohe konumohe, kaua e tangohia ma te waha
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