SARS-CoV-2 Antigen Assay Kit (Immunochromatography Method)
SARS-CoV-2 Antigen Assay Kit
(Immunochromatography Method) Product Manual
【PRODUCT NAME】SARS-CoV-2 Antigen Assay Kit(Immunochromatography Method)
【PACKAGING SPECIFICATIONS】1 Test/Kit
【ABSTRACT】
Cov kab mob tshiab coronaviruses yog nyob rau β genus. COVID-19 yog tus kab mob ua pa nyuaj. Tib neeg feem ntau raug mob. Tam sim no, cov neeg mob kis los ntawm tus kabmob tshiab no yog qhov tseem ceeb ntawm kev kis tus kabmob; Cov neeg mob asymptomatic kuj tuaj yeem yog qhov kis tau. Raws li kev tshawb nrhiav kev kis kabmob tam sim no, lub sijhawm incubation yog 1 txog 14 hnub, feem ntau yog 3 txog 7 hnub. Cov tsos mob tseem ceeb muaj xws li kub taub hau, qaug zog thiab hnoos qhuav. Qhov ntswg congestion, los ntswg qhov ntswg, mob caj pas, myalgia thiab raws plab yog pom nyob rau hauv ob peb kis.
【EXPECTED USAGE】
Cov khoom siv no yog siv los kuaj pom tus kab mob tshiab coronaviruses (SARS-CoV-2) antigen hauv tib neeg cov qaub ncaug hauv vitro. Nws tsuas yog tsim nyog rau kev kuaj mob hauv vitro, tsis yog siv rau tus kheej.
Cov khoom no tsuas yog siv hauv chaw kuaj mob lossis kuaj tam sim los ntawm cov neeg ua haujlwm kho mob. Nws tsis tuaj yeem siv rau kev sim hauv tsev.
Nws tsis tuaj yeem siv los ua lub hauv paus rau kev kuaj mob thiab tsis suav nrog kev mob ntsws los ntawm tus kab mob tshiab coronaviruses (SARS-CoV-2). Nws tsis haum rau kev tshuaj xyuas los ntawm cov pej xeem.
Qhov kev kuaj pom zoo yuav tsum muaj kev pom zoo ntxiv, thiab qhov kev kuaj pom tsis zoo tsis tuaj yeem txiav txim siab qhov muaj peev xwm kis tau.
【PRINCIPLES OF THE PROCEDURE】
Cov khoom no siv cov khoom siv colloidal kub immunochromatography technology, tshuaj tsuag colloidal kub sau npe SARS-CoV-2 mono-clonal antibody 1 ntawm lub ncoo kub The SARS-CoV-2 monoclonal antibody 2 yog coated rau nitrocellulose membrane raws li cov kab xeem (T kab) thiab tshis. anti-nas IgG antibody yog coated raws li kev tswj kab zoo (C kab). Thaum tus nqi tsim nyog ntawm tus qauv yuav raug kuaj ntxiv rau hauv qhov piv txwv ntawm daim npav xeem, tus qauv yuav txav mus tom ntej raws daim npav xeem hauv qab capillary ua. Yog tias tus qauv muaj SARS-CoV-2 antigen, cov tshuaj tiv thaiv yuav khi nrog cov xim kub uas sau tias SARS-CoV-2 monoclonal antibody 1, thiab lub cev tiv thaiv kab mob ua rau cov complex nrog cov coated SARS-CoV-2 monoclonal antibody 2 ntawm T kab, qhia cov kab liab-liab T kab, qhia tias SARS-CoV-2 antigen yog qhov zoo. Yog tias kab ntsuas T tsis pom xim thiab pom qhov tsis zoo, nws txhais tau tias cov qauv tsis muaj SARS-CoV-2 antigen. Daim npav xeem kuj tseem muaj kab tswj kev ua tau zoo C, tsis hais seb puas muaj kab xeem, cov kab liab liab-liab tswj kab C yuav tsum tshwm sim. Yog tias cov kab tswj kev ua tau zoo C tsis tshwm sim, nws qhia tau tias qhov kev xeem tsis raug, thiab cov qauv no yuav tsum tau sim dua.
【MAIN COMPONENTS】
(1) Daim npav xeem.
(2) Phau ntawv.
Lus Cim: Cov khoom sib txawv hauv cov khoom siv sib txawv tsis tuaj yeem siv sib hloov.
| Cat. No. | YXN-SARS-AT-01 |
| Package Specifications | 1 Test/Kit |
| Test cassette | 1 Test * 1 pob |
| Phau ntawv | 1 Daim |
【STORAGE AND EXPIRATION】
Lub sijhawm siv tau yog 18 lub hlis yog tias cov khoom no khaws cia rau hauv ib puag ncig ntawm 2 ℃ -30 ℃.
Cov khoom yuav tsum tau siv li ntawm 15 feeb thaum lub hnab ntawv qhib. Hnub tsim khoom thiab hnub tas sij hawm raug sau tseg rau ntawm daim ntawv lo.
【SAMPLE REQUIREMENTS】
1. Muaj feem xyuam rau tib neeg lub qhov ntswg caj pas swabs, qhov ncauj caj pas swabs, qaub ncaug qauv.
2. Qauv sau:
(1) Saliva collection(YXN-SARS-AT-01): Ua tes ntxuav tes nrog xab npum thiab dej / cawv-raws li xab npum. Qhib lub thawv. Ua ib lub suab nrov Kruuua los ntawm caj pas kom tshem cov qaub ncaug los ntawm caj pas tob, ces nchuav qaub ncaug (li 2 ml) rau hauv lub thawv. Zam kom tsis txhob muaj cov qaub ncaug paug ntawm qhov chaw sab nrauv ntawm lub thawv. Lub sijhawm zoo tshaj plaws ntawm kev sau cov qauv: Tom qab sawv thiab ua ntej txhuam hniav, noj lossis haus.
3. Ua cov qauv tam sim nrog cov qauv rho tawm hauv cov khoom siv tom qab sau cov qauv. Yog tias nws tsis tuaj yeem ua tiav tam sim ntawd, cov qauv yuav tsum muab cia rau hauv qhov qhuav, sterilized thiab nruj nreem kaw lub raj yas. Nws tuaj yeem khaws cia ntawm 2 ℃ -8 ℃ rau 8 teev, thiab tuaj yeem khaws cia rau lub sijhawm ntev ntawm -70 ℃.
4. Cov qauv uas muaj kab mob hnyav heev los ntawm cov khoom noj hauv qhov ncauj tsis tuaj yeem siv los kuaj cov khoom no. Cov qauv sau los ntawm swabs uas khov heev los yog agglomerated tsis pom zoo rau kev sim cov khoom no. Yog tias cov swabs muaj cov ntshav ntau, lawv tsis pom zoo rau kev kuaj. Nws tsis pom zoo kom siv cov qauv uas tau ua tiav nrog cov qauv rho tawm cov tshuaj tsis tau muab rau hauv cov khoom siv no rau kev kuaj cov khoom no.
【TESTING METHOD】
Thov nyeem phau ntawv qhia ua tib zoo ua ntej kuaj. Thov xa rov qab tag nrho cov reagents rau hauv chav tsev kub ua ntej qhov kev xeem. Qhov ntsuas yuav tsum tau ua nyob rau hauv chav tsev kub.
Cov kauj ruam xeem:
1.Saliva qauv (YXN-SARS-AT-01):
(1) Tom qab cov ntawv xeem rov qab mus rau hauv chav tsev kub, qhib lub hnab ntawv aluminium thiab tshem tawm cov ntawv xeem thiab muab tso rau hauv kab rov tav ntawm lub desktop.
(2) Tshem tawm qhov kawg ntawm lub tshuab ntsuas ntsuas, muab cov pas ntsuas ntsuas ntsuas hauv cov qaub ncaug, lossis tso cov pas ntsuas ntsuas ntsuas hauv qab tus nplaig rau 2 feeb.
(3) Khaws lub tshuab ntsuas ntsuas kom ncaj thiab cia cov kua qaub ncaug txav mus rau sab saud kom txog thaum nws ncav cuag lossis txav mus hla Kab C, tom qab ntawd muab lub hau rov qab thiab tso cov ntawv ntsuas ntsuas ntawm lub rooj.
(4) Nyeem cov txiaj ntsig tau tshwm sim hauv 15-30 feeb, thiab cov txiaj ntsig tau nyeem tom qab 30 feeb tsis raug.
【[INTERPRETATION OF TEST RESULTS】
| ★ Ob txoj kab xeem (T) thiab kab tswj (C) qhia cov xim xim raws li daim duab qhia raws li txoj cai, qhia tias SARS-CoV-2 antigen yog qhov zoo. | |
| ★NEGATIVE: Yog tias tsuas yog cov kab tswj kev ua tau zoo C tsim xim thiab cov kab xeem (T) tsis tsim xim, SARSCoV-2 antigen tsis raug kuaj pom thiab qhov tshwm sim tsis zoo, raws li daim duab qhia raws li txoj cai. | |
| ★ INVALID: Tsis muaj xim band tshwm nyob rau ntawm kab tswj zoo (C), thiab nws raug txiav txim raws li qhov tshwm sim tsis tau txawm hais tias cov kab kuaj pom (T) qhia cov xim xim los yog tsis, raws li daim duab qhia raws li txoj cai.Control kab tsis ua tshwm sim.Cov qauv ntim tsis txaus lossis cov txheej txheem tsis raug yog qhov feem ntau yuav ua rau kev tswj kab tsis ua haujlwm.Saib cov txheej txheem thiab rov ua qhov kev sim nrog cov ntawv ntsuas tshiab.Yog tias qhov teeb meem tshwm sim, txiav siv cov khoom siv kuaj tam sim ntawd thiab tiv tauj koj tus neeg muag khoom hauv zos. |
【LIMITATION OF DETECTION METHOD】
1. Kev soj ntsuam xyuas
Txhawm rau ntsuas qhov kev kuaj mob ua tau zoo, txoj kev tshawb no tau siv COVID- 19-cov qauv zoo los ntawm 150 tus tib neeg thiab COVID-19-cov qauv tsis zoo los ntawm 350 tus neeg. Cov qauv no tau sim thiab lees paub los ntawm RT-PCR txoj kev. Cov txiaj ntsig yog raws li nram no:
a) rhiab heev: 92.67% (139/150), 95% CI (87.26%, 96.28%).
b) Specification: 98.29% (344/350), 95% CI (96.31%, 99.37%).
2. Yam tsawg kawg ntawm kev kuaj pom:
Thaum tus kab mob cov ntsiab lus ntau dua 400TCID50 / ml, qhov kev kuaj pom zoo yog ntau dua 95%. Thaum tus kab mob cov ntsiab lus tsawg dua 200TCID50 / ml, qhov kev kuaj pom qhov zoo yog tsawg dua 95%, yog li qhov ntsuas qhov tsawg kawg nkaus ntawm cov khoom no yog 400TCID50 / ml.
3. Precision:
Peb sib law liag ntawm cov reagents tau sim rau qhov tseeb. Cov khoom sib txawv ntawm cov tshuaj reagents tau siv los kuaj tib tus qauv tsis zoo 10 zaug hauv kev sib txuas, thiab cov txiaj ntsig tau zoo tag nrho. Cov khoom sib txawv ntawm cov tshuaj reagents tau siv los kuaj tib tus qauv zoo 10 zaug hauv kev sib txuas, thiab cov
cov txiaj ntsig tau zoo tag nrho.
4. HOOK effect:
Thaum tus kab mob cov ntsiab lus nyob rau hauv cov qauv yuav tsum tau kuaj mus txog 4.0 * 105TCID50 / ml, qhov kev ntsuam xyuas tseem tsis qhia HOOK nyhuv. 5. Hla-reactivity
Hla-reactivity ntawm Cov Khoom Siv tau raug soj ntsuam. Cov txiaj ntsig tau pom tsis muaj qhov cuam tshuam cuam tshuam nrog cov qauv hauv qab no.
| No | Yam khoom | Conc | No | Yam khoom | Conc |
| 1 | HKOV-HKU 1 | 105 TSI 50/ml | 16 | Influenza A H3N2 | 105 TSI 50/ml |
| 2 | Staphylococcus aureus | 106 TSI 50/ml | 17 | H7N 9 | 105 TSI 50/ml |
| 3 | Pab pawg A streptococci | 106 TSI 50/ml | 18 | H5N1 | 105 TSI 50/ml |
| 4 | Tus kab mob qhua pias | 105 TSI 50/ml | 19 | Epstein-Barr tus kab mob | 105 TSI 50/ml |
| 5 | Mumps tus kab mob | 105 TSI 50/ml | 20 | Enterovirus CA16 | 105 TSI 50/ml |
| 6 | Adenovirus yam 3 | 105 TSI 50/ml | 21 | Rhinovirus | 105 TSI 50/ml |
| 7 | Mycoplasmal pneumonia | 106 TSI 50/ml | 22 | Tus kab mob vais lav ua mob rau txoj hlab ua pa | 105 TSI 50/ml |
| 8 | Paraimfluenzavirus, hom 2 | 105 TSI 50/ml | 23 | Streptococcus pneumoniae | 106 TSI 50/ml |
| 9 | Tib neeg metapneumovirus | 105 TSI 50/ml | 24 | Candida albicans | 106 TSI 50/ml |
| 10 | Human coronavirus OC43 | 105 TSI 50/ml | 25 | Chlamydia pneumoniae | 106 TSI 50/ml |
| 11 | Human Coronavirus 229E | 105 TSI 50/ml | 26 | Bordetella pertussis | 106 TSI 50/ml |
| 12 | Bordetella kab mob | 106 TSI 50/ml | 27 | Pneumocystis jiroveci | 106 TSI 50/ml |
| 13 | Influenza B Victoria hom kab mob | 105 TSI 50/ml | 28 | Mycobacterium tubercu losis | 106 TSI 50/ml |
| 14 | Influenza B Y kab mob | 105 TSI 50/ml | 29 | Legionella pneumophila | 106 TSI 50/ml |
| 15 | Influenza A H1N1 2009 | 105 TSI 50/ml |
6. Cov khoom cuam tshuam
Cov txiaj ntsig kev ntsuas tsis cuam tshuam nrog cov khoom ntawm cov ntsiab lus hauv qab no:
| No | Yam khoom | Conc | No | Yam khoom | Conc |
| 1 | Ntshav tag nrho | 4% | 9 | Mucin | 0 50% |
| 2 | Ibuprofen | 1 mg/ml | 10 | Compound Benzoin Gel | 1.5 mg/ml |
| 3 | tshuaj tetracycline | 3 ug/ml | 11 | Cromolyn glycate | 15% |
| 4 | chloramphenicol | 3 ug/ml | 12 | Deoxyepinephrine hydrochloride | 15% |
| 5 | Erythromycin | 3 ug/ml | 13 | Afrin | 15% |
| 6 | Tobramycin | 5% | 14 | Fluticasone propionate tshuaj tsuag | 15% |
| 7 | Oseltamivir | 5 mg/ml | 15 | menthol | 15% |
| 8 | Naphazoline Hydrochlo caij Nasal Drops | 15% | 16 | Mupirocin | 10 mg/ml |
【LIMITATION OF DETECTION METHOD】
1. Cov khoom no tsuas yog muab rau cov chaw kuaj mob lossis cov neeg ua haujlwm kho mob rau kev kuaj tam sim, thiab tsis tuaj yeem siv rau kev kuaj hauv tsev.
2. Cov khoom no tsuas yog tsim nyog rau kev tshawb pom ntawm tib neeg lub qhov ntswg kab noj hniav lossis cov caj pas zais zis. Nws kuaj pom tus kab mob cov ntsiab lus hauv cov qauv rho tawm, tsis hais seb tus kab mob puas kis tau. Yog li ntawd, cov txiaj ntsig ntawm cov khoom no thiab cov kab lis kev cai kab lis kev cai ntawm tib tus qauv yuav tsis cuam tshuam.
3. Daim ntawv xeem thiab cov qauv rho tawm cov khoom siv no yuav tsum tau muab rov qab rau hauv chav sov ua ntej siv. Qhov ntsuas kub tsis raug yuav ua rau muaj qhov txawv txav.
4. Thaum lub sijhawm kuaj, cov txiaj ntsig kev kuaj yuav tsis sib haum nrog cov txiaj ntsig ntawm kev kho mob vim tsis muaj cov qauv sau tsis txaus ntawm cov kab mob tsis muaj menyuam lossis kev sau tsis raug thiab kev ua haujlwm ntawm cov khoom siv.
5. Thaum lub sij hawm siv cov khoom no, koj yuav tsum nruj me ntsis ua raws li kev khiav hauj lwm cov kauj ruam ntawm phau ntawv. Cov kauj ruam ua haujlwm tsis raug thiab ib puag ncig tej zaum yuav ua rau cov txiaj ntsig tsis zoo.
6. Lub swab yuav tsum tau tig li ntawm 10 zaug ntawm cov phab ntsa sab hauv ntawm lub raj kuaj uas muaj cov qauv rho tawm. Kev sib hloov tsawg dhau los yog ntau dhau tuaj yeem ua rau cov txiaj ntsig tsis zoo.
7. Qhov txiaj ntsig zoo ntawm cov khoom no tsis tuaj yeem txiav txim siab qhov ua tau ntawm lwm cov kab mob ua rau qhov zoo.
8. Qhov kev kuaj pom tsis zoo f cov khoom no tsis tuaj yeem txiav txim siab qhov muaj peev xwm ntawm lwm cov kab mob zoo.
9. Cov txiaj ntsig tsis zoo raug pom zoo kom raug txheeb xyuas nrog cov nucleic acid nrhiav kom tau cov tshuaj tiv thaiv kom tsis txhob muaj kev pheej hmoo ntawm kev kuaj tsis tau.
10. Tej zaum yuav muaj qhov sib txawv ntawm cov txiaj ntsig ntawm kev kuaj mob khov thiab cov qauv tshuaj tshiab uas tau sau tseg.
11. Cov qauv yuav tsum tau kuaj tam sim tom qab sau kom tsis txhob muaj qhov txawv txav tom qab tau tso tseg ntev dhau lawm.
12. Thaum lub sij hawm siv cov khoom no, yuav tsum muaj tus qauv tsim nyog, tsawg lossis ntau tus qauv yuav ua rau cov txiaj ntsig tsis zoo. Nws raug nquahu kom siv lub pipette nrog cov qauv ntsuas kom raug ntau dua rau cov qauv ntsuas ntxiv.
【PRECAUTIONS】
1. Thov sib npaug ntawm cov qauv diluent thiab kuaj daim npav rau chav tsev kub (siab tshaj 30min) ua ntej kuaj.
2. Kev tshuaj xyuas yuav tsum tau ua raws li cov lus qhia nruj.
3. Cov txiaj ntsig yuav tsum tau txhais tsis pub dhau 15-30min, thiab cov txiaj ntsig tau nyeem tom qab 30 min tsis raug.
4. Cov qauv kuaj yuav tsum raug suav tias yog cov khoom sib kis, thiab kev ua haujlwm yuav tsum tau ua raws li kev ua haujlwm tshwj xeeb ntawm chav kuaj kab mob sib kis, nrog rau kev tiv thaiv kev tiv thaiv thiab ua tib zoo saib xyuas kev ua haujlwm bio-kev nyab xeeb.
5. Cov khoom no muaj cov khoom siv los ntawm tsiaj. Txawm hais tias nws tsis kis tau, nws yuav tsum tau kho nrog ceev faj thaum tuav cov peev txheej ntawm tus kab mob. Cov neeg siv yuav tsum muaj kev tiv thaiv kom muaj kev nyab xeeb ntawm lawv tus kheej thiab lwm tus.
6. Cov ntawv xeem siv, cov qauv rho tawm, thiab lwm yam raug kho raws li bio-kev kho mob pov tseg tom qab kuaj, thiab ntxuav koj txhais tes raws sijhawm.
7. Yog tias cov qauv kev kho mob ntawm cov khoom no ua rau poob rau hauv daim tawv nqaij lossis ob lub qhov muag, thov yaug sai sai nrog dej ntau, thiab nrhiav kev kho mob yog tias tsim nyog.
8. Tsis txhob siv cov khoom siv nrog kev puas tsuaj, thiab daim ntawv xeem nrog pob puas.
9. Cov khoom no yog cov khoom siv ib zaug, thov tsis txhob rov siv dua, thiab tsis txhob siv cov khoom siv tas sijhawm.
10. Tsis txhob raug tshav ntuj ncaj qha thiab ncaj qha los ntawm cov kiv cua hluav taws xob thaum kuaj.
11. Cov dej kais dej, dej distilled lossis deionized dej thiab dej haus tsis tuaj yeem siv los ua cov tshuaj tiv thaiv tsis zoo.
12. Vim qhov txawv ntawm cov qauv, qee cov kab xeem yuav sib dua lossis greyish xim. Raws li cov khoom lag luam zoo, tsuav yog muaj ib pawg ntawm txoj haujlwm ntawm T kab, nws tuaj yeem txiav txim siab zoo.
13. Yog tias qhov kev kuaj ntawd zoo, nws raug nquahu kom siv daim npav xeem no rov kuaj dua ib zaug kom tsis txhob muaj qhov tshwm sim me me.
14. Muaj ib lub desiccant nyob rau hauv lub hnab ntawv aluminium, tsis txhob noj nws qhov ncauj
Cov khoom muaj feem xyuam
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