SARS-CoV-2 Antigen Assay Kit (Njira ya Immunochromatography)

SARS-CoV-2 Antigen Assay Kit

(Immunochromatography Method) Product Manual

【PZotsatira RODUCT NAME】SARS-CoV-2 Antigen Assay Kit(Njira ya Immunochromatography)

【PACKAGING SPECIFICATIONS】1 Mayeso / Kit

【ABSTRACT】

Ma coronaviruses atsopano ndi amtundu wa β. COVID-19 ndi matenda opatsirana pachimake. Nthawi zambiri anthu amavutika. Pakadali pano, odwala omwe ali ndi kachilombo ka coronavirus ndiye gwero lalikulu la matenda; anthu omwe ali ndi matenda asymptomatic amathanso kukhala gwero lopatsirana. Malingana ndi kafukufuku wamakono wa epidemiological, nthawi yobereketsa ndi masiku 1 mpaka 14, makamaka masiku 3 mpaka 7. The mawonetseredwe aakulu monga malungo, kutopa ndi youma chifuwa. Kutsekeka kwa mphuno, mphuno, zilonda zapakhosi, myalgia ndi kutsekula m'mimba zimapezeka nthawi zingapo.

【EXPECTED USAGE】

Chidachi chimagwiritsidwa ntchito kuzindikira bwino lomwe buku la coronaviruses (SARS-CoV-2) antigen mu zitsanzo za malovu amunthu mu vitro. Ndiwoyenera kuzindikiridwa ndi akatswiri mu vitro, osati kugwiritsa ntchito nokha.

Izi zimangogwiritsidwa ntchito m'ma laboratories azachipatala kapena kuyezetsa mwachangu ndi ogwira ntchito zachipatala. Sichingagwiritsidwe ntchito poyesa kunyumba.

Sichingagwiritsidwe ntchito ngati maziko ozindikiritsa ndikupatula chibayo choyambitsidwa ndi matenda a coronaviruses (SARS-CoV-2). Sikoyenera kuwunika ndi anthu wamba.

Zotsatira zoyezetsa zimafuna kutsimikiziridwa kwina, ndipo zotsatira zoyezetsa sizingalepheretse kuthekera kwa matenda.

【PRINCIPLES OF THE PMtengo ROCEDURE】

Izi zimagwiritsa ntchito ukadaulo wa colloidal gold immunochromatography, kupopera golide wa colloidal wolembedwa SARS-CoV-2 mono-clonal antibody 1 pa golide pad The SARS-CoV-2 monoclonal antibody 2 imakutidwa pa nembanemba ya nitrocellulose ngati mzere woyeserera (T mzere) ndi mbuzi. Anti-mbewa IgG antibody imakutidwa ngati mzere wowongolera (C mzere). Pamene chiwerengero choyenera cha chitsanzo kuti chiyesedwe chikuwonjezedwa ku dzenje lachitsanzo la khadi loyesa, chitsanzocho chidzapita patsogolo pa khadi loyesa pansi pa capillary action. Ngati chitsanzocho chili ndi antigen ya SARS-CoV-2, antigen imamanga ndi golide wa colloidal wotchedwa SARS-CoV-2 monoclonal antibody 1, ndipo chitetezo chamthupi chimapanga chovuta chokhala ndi SARS-CoV-2 monoclonal antibody 2 Mzere wa T, wosonyeza mzere wa T wofiirira, kusonyeza kuti antigen ya SARS-CoV-2 ndi yabwino. Ngati mzere woyesera T sukuwonetsa mtundu ndikuwonetsa zotsatira zoyipa, zikutanthauza kuti chitsanzocho chilibe antigen ya SARS-CoV-2. Khadi loyesera limakhalanso ndi mzere wowongolera khalidwe C, mosasamala kanthu kuti pali mzere woyesera, mzere wamtundu wofiirira-wofiira C uyenera kuonekera. Ngati mzere wowongolera khalidwe C sukuwonekera, zimasonyeza kuti zotsatira zake ndizosavomerezeka, ndipo chitsanzochi chiyenera kuyesedwa kachiwiri.

【MAIN COMPONENTS】

( 1) Khadi loyesera.

(2) Pamanja.

Zindikirani: Zomwe zili m'magulu osiyanasiyana a zida sizingagwiritsidwe ntchito mosiyana.

【STORAGE AND EXPIRATION】

Nthawi yovomerezeka ndi miyezi 18 ngati mankhwalawa asungidwa m'malo a 2 ℃-30 ℃.

Mankhwalawa ayenera kugwiritsidwa ntchito mkati mwa mphindi 15 kamodzi thumba la zojambulazo litatsegulidwa. Phimbani chivindikirocho mwamsanga mutatulutsa njira yothetsera chitsanzo. Tsiku lotulutsa ndi tsiku lotha ntchito zalembedwa pa lebulo.

【SAMPLE REQUIREMENTS】

1. Zogwiritsidwa ntchito paziphuphu zapakhosi zapamphuno zapakhosi, zapakhosi zapakamwa, zitsanzo zamalovu.

2. Zosonkhanitsira zitsanzo:

( 1) Kutolere malovu (YXN-SARS-AT-01): Chitani ukhondo m'manja ndi sopo ndi madzi / kupaka m'manja motengera mowa. Tsegulani chidebecho. Pangani phokoso la Kruuua 'pakhosi kuti muchotse malovu akukhosi, kenako kulavulira malovu (pafupifupi 2 ml) mumtsuko. Pewani kuipitsidwa ndi malovu akunja kwa chidebecho. Nthawi yoyenera yosonkhanitsa zitsanzo: Mukadzuka ndisanatsuka mano, kudya kapena kumwa.

3. Pangani chitsanzocho nthawi yomweyo ndi njira yothetsera chitsanzo yomwe imaperekedwa muzitsulo pambuyo pa kusonkhanitsa. Ngati sichingasinthidwe nthawi yomweyo, chitsanzocho chiyenera kusungidwa mu chubu chapulasitiki chouma, chosawilitsidwa komanso chosindikizidwa kwambiri. Zitha kusungidwa pa 2 ℃ -8 ℃ kwa maola 8, ndipo zitha kusungidwa kwa nthawi yayitali pa -70 ℃.

4. Zitsanzo zomwe zaipitsidwa kwambiri ndi zotsalira zapakamwa sizingagwiritsidwe ntchito poyesa mankhwalawa. Zitsanzo zomwe zasonkhanitsidwa kuchokera ku swabs zomwe zili zowoneka bwino kwambiri kapena zophatikizika sizovomerezeka kuyesa mankhwalawa. Ngati ma swabs ali oipitsidwa ndi magazi ambiri, savomerezedwa kuti ayesedwe. Sitikulimbikitsidwa kugwiritsa ntchito zitsanzo zomwe zimakonzedwa ndi njira yotulutsira zitsanzo zomwe sizinaperekedwe mu chida ichi poyesa mankhwalawa.

【TESTING METHOD】

Chonde werengani buku la malangizo mosamala musanayese. Chonde bweretsani ma reagents onse kutentha kwachipinda musanayese. Mayeso ayenera kuchitidwa kutentha.

Njira Zoyesera:

1.Zitsanzo zamalovu(YXN-SARS-AT-01):

( 1) Kaseti yoyesera ikabwerera ku kutentha kwa chipinda, tsegulani chikwama cha aluminiyamu chojambulapo ndikutulutsa kaseti yoyesera ndikuyiyika mopingasa pakompyuta.

(2) Chotsani nsonga ya kaseti yoyesera, ikani ndodo yoyesera m’malovu, kapena ikani ndodo yoyesera pansi pa lilime kwa mphindi ziwiri.

(3) Sungani kaseti yoyesera mowongoka ndipo mulole malovu asunthire mmwamba mpaka afikire kapena kusuntha pa Mzere C, kenaka bwezeretsani chivindikiro ndikuyika kaseti yoyesera pa desiki.

(4) Werengani zotsatira zomwe zawonetsedwa mkati mwa mphindi 15-30, ndipo zotsatira zomwe zawerengedwa pakatha mphindi 30 ndizosavomerezeka.

【[INTERPRETATION OF TEST RESULTS】

【LIMITATION OF DZIWANIION METHOD】

1. Kutsimikizira kwachipatala

Pofuna kuwunika momwe matenda akuyendera, kafukufukuyu adagwiritsa ntchito zitsanzo za COVID-19 kuchokera kwa anthu 150 komanso za anthu 350 omwe alibe COVID-19. Zitsanzozi zinayesedwa ndikutsimikiziridwa ndi njira ya RT-PCR. Zotsatira zake ndi izi:

a) Kukhudzidwa: 92.67% (139/150), 95%CI (87.26%, 96.28%).

b) Zodziwika: 98.29% (344/350), 95%CI (96.31%, 99.37%).

2. Malire ochepera ozindikira:

Pamene kachilombo kameneka kakuposa 400TCID50/ml, chiwerengero chodziwika bwino chimakhala chachikulu kuposa 95%. Pamene kachilombo kameneka kakucheperachepera 200TCID50/ml, chiwerengero chodziwika bwino chimakhala chocheperapo 95%, kotero kuti malire odziwika a mankhwalawa ndi 400TCID50/ml.

3. Kulondola:

Magulu atatu otsatizana a reagents adayesedwa molondola. Magulu osiyanasiyana a reagents adagwiritsidwa ntchito kuyesa zitsanzo zoyipa zomwezo nthawi 10 motsatizana, ndipo zotsatira zake zonse zinali zoipa. Magulu osiyanasiyana a reagents adagwiritsidwa ntchito kuyesa zitsanzo zabwino zomwezo ka 10 motsatizana, ndi

zotsatira zonse zinali zabwino.

4. HOOK zotsatira:

Pamene kachilombo ka HIV kamene kayezedwe kakafika pa 4.0 * 105TCID50/ml, zotsatira zake siziwonetsabe zotsatira za HOOK. 5. Cross-reactivity

Cross-reactivity of the Kit idawunikidwa. Zotsatira zake sizinawonetse kuyanjananso ndi chitsanzo chotsatirachi.

6. Zinthu Zosokoneza

Zotsatira zoyezetsa sizisokonezedwa ndi zinthu pamiyeso iyi:

【LIMITATION OF DZIWANIION METHOD】

1. Izi zimangoperekedwa kwa ma laboratories azachipatala kapena ogwira ntchito zachipatala kuti ayesedwe msanga, ndipo sangathe kugwiritsidwa ntchito poyesa kunyumba.

2. Mankhwalawa ndi oyenerera kuti azindikire mphuno ya munthu kapena zitsanzo za katulutsidwe ka mmero. Imazindikira zomwe zili ndi kachilomboka muzachitsanzo, mosasamala kanthu kuti kachilomboka ndi kachilombo. Choncho, zotsatira za mayeso a mankhwalawa ndi zotsatira za chikhalidwe cha kachilombo kachitsanzo chomwecho sizingagwirizane.

3. Khadi loyesera ndi njira yochotsera zitsanzo za mankhwalawa ziyenera kubwezeretsedwa kutentha kwa chipinda musanagwiritse ntchito. Kutentha kolakwika kungayambitse zotsatira za mayeso.

4. Panthawi yoyesera, zotsatira za mayesero sizingafanane ndi zotsatira zachipatala chifukwa cha kusakwanira kwa zitsanzo za swabs zosabala kapena kusonkhanitsa kosayenera ndi ntchito yochotsa zitsanzo.

5. Pogwiritsa ntchito mankhwalawa, muyenera kutsatira mosamalitsa njira zoyendetsera bukhuli. Njira zosayenera zogwirira ntchito ndi momwe chilengedwe chingayambitse zotsatira zoyesa.

6. Chophimbacho chiyenera kuzunguliridwa pafupifupi nthawi za 10 pakhoma lamkati la chubu choyesera chomwe chili ndi njira yothetsera chitsanzo. Kasinthasintha pang'ono kapena kuchulukira kungayambitse zotsatira za mayeso.

7. Zotsatira zabwino za mankhwalawa sizingalepheretse kuthekera kwa tizilombo toyambitsa matenda ena kukhala abwino.

8. Zotsatira zoyipa ngati mankhwalawa sangaletse kuthekera kwa tizilombo toyambitsa matenda ena kukhala ndi HIV.

9. Zotsatira zoyipa zoyesa zimalimbikitsidwa kuti zitsimikizidwe ndi nucleic acid kuzindikira reagents kupewa chiopsezo chophonya mayeso.

10. Pakhoza kukhala kusiyana kwa zotsatira za mayeso pakati pa zitsanzo zachipatala zozizira ndi zitsanzo zachipatala zomwe zasonkhanitsidwa kumene.

11. Chitsanzochi chiyesedwe mwamsanga mukatolera kupeŵa zotsatira zachilendo chikasiyidwa kwa nthawi yayitali.

12. Mukamagwiritsa ntchito mankhwalawa, kuchuluka kwachitsanzo koyenera ndikofunikira, zochepa kwambiri kapena kuchuluka kwachitsanzo kungayambitse zotsatira zachilendo. Ndibwino kuti mugwiritse ntchito pipette yokhala ndi voliyumu yolondola kwambiri yoyesera chitsanzo chowonjezera.

【PRECAUTIONS】

1. Chonde gwirizanitsani chitsanzo cha diluent ndi khadi loyesa kutentha kwa chipinda (pamwamba pa 30min) musanayese.

2. Kuyendera kuyenera kuchitidwa motsatira malangizo.

3. Chotsatiracho chiyenera kutanthauziridwa mkati mwa 15-30min, ndipo zotsatira zowerengedwa pambuyo pa 30 min ndizolakwika.