Tsarin Tsarin Tsarin Gudanar da SARS-Cov-2 Antigen Rapid

A takaice bayanin:

Gyara 500210 Gwadawa 1 Gwaji / Akwatin
Ka'idojin ganowa Antickermacomogric assay Samfura
Yau
Amfani da aka yi niyya Yar amaryaTsarin tsari na tsarin SARS-Cov-2antigen da sauri gwajin riguna impyyy ya yi amfani da impunochromato Wannan gwajin ba shi da guda ɗaya kawai kuma an yi nufin gwajin kai. An ba da shawarar yin amfani da wannan gwajin a cikin kwanaki 7 na alamar alama. kimantawa ta hanyar kimantawa na dattic.

 


Cikakken Bayani

Tags samfurin

Amfani da aka yi niyya

Tsarin tsari na SARS na COV-2 Antigen mai saurin gwajin ƙwaƙwalwar rigakafi yana ɗaukar fasahar rigakafi don gano maganin rigakafi na sars-2. Wannan gwajin ba shi da guda ɗaya kawai kuma an yi niyya don gwajin sei. An ba da shawarar yin amfani da wannan gwajin a cikin kwanaki 7 na alamar alama ta farko da kimantawa ta asibiti.

Shigowa da

Da labari Morenaviruse na 0 GENU. COVID-19 cuta ce mai saurin cutar. Mutane gaba daya mai saukin kamuwa. A halin yanzu, marasa lafiya da cutar Coronavirus sune babban tushen kamuwa da cuta wanda ke haifar da kwanaki 1 zuwa 14, galibi 3 zuwa 7 zuwa 7 kwanaki. Babban bayyanar sun hada da zazzabi, gajiya da bushe tari. Rashin ambaliya, hanci hanci, ciwon makogwaro, myalgia ana samun sa a cikin fewan lokuta.

Ƙa'ida

Gwajin tsarin SARK na COV-2-2 2-2 Antigen Antigen da gwajin rigakafi gwajin daga gaban katin gwajin, da kuma samfurori na yau da kullun suna ci gaba a karkashin aikin City. Idan samfurin ya ƙunshi SARS-2 n furotin antigen.it an gano shi da ɗaure ta hanyar maganin rigakafi da aka yiwa alama a farfajiya don samar da hadaddun kariya. Lokacin da hadaddun shaye-shaye ta ƙaura zuwa ga nitric acid membrane layin ganowa, don gano layin da aka cakuda kuma samar da layin gano fuchsia (t-lin), yana nuna tabbataccen abu; Idan T-line bai nuna launi ba, sakamako ne mara kyau. Wani layin a kan membrane na Nitric orth acid an cika shi da magunguna na Steptavdin.

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MATAKAN KARIYA

• Wannan kit ɗin yana cikin amfani da bincike kawai.
• Ana iya sarrafa wannan kit ɗin ta hanyar likita ko marasa lafiya ta hanyar bin umarnin aiki.
• Karanta umarnin a hankali kafin yin gwajin.
• Wannan samfurin bai ƙunshi kowane kayan asalin ɗan adam ba.
• Kada kayi amfani da abubuwan da ke ciki bayan ranar karewa.
• rike duk samfurori a matsayin mai yiwuwa.
• Kada kayi maganin bututun ciki da baki kuma babu shan taba ko cin abinci yayin aiwatar da magoya.
• sanya safofin hannu a lokacin duka hanya.

Adana da kwanciyar hankali

Shafin da aka rufe a cikin kayan gwajin na iya adana tsakanin 2-30 ° C na tsawon lokacin da aka yiwa niyyar da aka nuna a kan jakar.

Samfuran samfuran da ajiya

Mafi kyawun samfuran Salin Salin ya kamata ya tara da safe bayan farka. Kada ku ci ko shan komai tsawon minti 30 kafin tattara samfurin yau da kullun. Yi shi kafin cin kofi, cin karin kumallo, ko goge haƙoranku - ko jira har sai kun cinye komai a cikin minti 30.

Hanya

Ku kawo gwaji zuwa zazzabi dakin (15-30 ° C) kafin amfani.
Mataki na 1:
Bude jaka, cire na'urar gwajin, buɗe murfin ƙarshen na'urar gwajin.
Mataki na 2:
• Riƙe Casette Cassette, sanya itacen adan.
• Raba na'ura madaidaiciya kuma bari salula ruwa don matsawa sama har sai isa sama C, sannan toshe hula baya.
Sanya na'urar a sarari akan aikin.
Mataki na 3:
Re-lokaci kuma karanta Ganawar Gano 15 Minti Bayan haka.
A hankali yakan jefa sharar gida a cikin akwati na Biohaz-Ad.

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Iko mai inganci

Gudanar da Gudanar da Cikin Gida suna cikin gwajin. Ana bayyana band na shuɗi a cikin yankin sarrafawa (C) azaman ikon shiga cikin ciki. Ya tabbatar da isasshen ƙimar ƙirar da madaidaiciyar hanyar aiwatarwa.

Iyakancewar gwaji

1. Kit ɗin an yi nufin amfani da shi ne don gano cancantar gano SARS-Cov-2 antigens daga yau.
2. Wannan gwajin yana gano duka biyu mai yiwuwa (live) da ba za a iya yiwuwa raba-cov-2 ba. Aikin gwaji ya dogara da adadin kwayar cuta (Antigen) a cikin samfurin da kuma iya daidaitawa tare da sakamakon al'adun kwamfuta akan samfurin.
3. Sakamakon gwajin gwaji na iya faruwa idan matakin antigen a cikin wani samfurin yana ƙasa da iyakokin ganowa ko kuma idan an tattara samfurin ba daidai ba.
4. Rashin bin hanyar gwajin na iya shafar aiwatar da gwaji da / ko lalata sakamakon gwajin.
5. Kit ɗin yana don ɗaukar hoto kawai. Sakamakon sakamako mara kyau Kada ku yi mulkin fita daga kamuwa da SARS-2 da mutumin da ba ya zama mai kamuwa da cuta. Idan bayyanar cututtuka suna nan, nemi ƙarin gwaji na gaggawa.
6. Dole ne a daidaita sakamakon gwaji tare da tarihin asibiti, bayanan annashuwa, da sauran bayanan da ke samarwa ga asibitin suna kimanta mai haƙuri.
7. Sakamakon gwajin ba zai yi watsi da tarin cutar tare da sauran wuraren ba kuma ba lallai ba ne sanin ko mutum mai kamuwa da cuta.
8. Ba a yi nufin sakamako na gwaji mara kyau ba don yin mulki a cikin wasu ba SARS ɗin kwayoyin cuta ko cututtukan ƙwayar cuta.
9. Sakamakon sakamako daga marasa lafiya da alama, ya kamata a kula da shi azaman mai ɗaukar hoto na gida mai izini, idan ya cancanta, har da ikon sarrafawa.
10. Shawarwarin ingantattun bayanai sun dogara ne akan bayanan kwanciyar hankali daga gwajin mura da aikin na iya bambanta da SARS-2-2. Masu amfani su gwada samfurori da sauri bayan samfuran samfuri.
11. Abin sani ga RT-PCR Asay a cikin ganewar cuta ta COVID-19 ne kawai% na rashin daidaituwa na kayan gwajin na kayan aikin gwajin damar da aka murmurewa ƙananan saboda hanyoyin sa.
12. Kyakkyawan ƙimar tsinkaya mara kyau suna dogara sosai kan farashin tafarki.
Sakamakon gwajin zai iya wakiltar kyakkyawan sakamako na karya a lokacin lokaci na ɗan ƙaramin abu / No sakamakon gwajin SSS.
13. Abun halittar monoclonal na iya kasa ganowa, ko ganowa da karancin hankali, kwayar cutar SARS-COV-2 wadanda suka canza karamin canje-canje a yankin Epitope.
14. Ba a kimanta aikin wannan gwajin don amfani da marasa lafiya ba tare da alamun kamuwa da cuta da aiki na iya bambanta da mutane asymptomatics.
15. Adadin antigen a cikin samfurin na iya raguwa kamar tsawon lokacin rashin lafiya yana ƙaruwa.
Dukkan samfurori sun tattara bayan kwana 7 na rashin lafiya sun fi dacewa idan an kwatanta su da ACK PCR Assay.
Sanarwar gwajin bayan kwana bakwai na farko na bayyanar cututtuka da aka san don ragewa kamar yadda aka kwatanta da Accr Assay.
16. Ba da shawarar yin amfani da kafofin watsa labarai na kwayar cutar (vtm) a cikin wannan gwajin ba, idan abokan ciniki sun nace don amfani da wannan nau'in, abokan ciniki sun inganta kansu.
17. Gwaji akai-akai ya zama dole don ƙara yawan jin daɗin bayyanar cututtuka na Covid-19.
18. Babu digo a cikin hankali idan aka kwatanta da nau'in daji dangane da masu zuwa na bambance-bambancen -b.1.1.7; B.1.351; B.1.2; B.1.1.28; B.1.617; B.1.1.522.
19. Sakamakon sakamako mai kyau ya nuna cewa an gano maganin antigens da bidiyo da sauri a cikin samfurin da aka ɗauka da kuma sanar da likitan danginku da / ko sashen kula da lafiyar ku.

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Yarjejeniyar Kudi: (PPA) = 98.02% (93.03% ~ 99.76%) *

Yarjejeniyar Bala'i: (NPA) = 100% (98.23% ~ 100%) *

Jimlar daidaituwa = 98.76%

* 95% amincewa tazara

Nazarin Nazarin

a) Iyakar ganewa (LOD):

Iyakar ganowa (lod) na gwajin an ƙaddara ta amfani da iyakance dilutions na Inact-2-2 2. Shirye-shiryen coronavirus-2 ne (SARS-2), an keɓe shi a CDC CDC, wanda ya kasance an ɓoye shi ta hanyar β-Periolacting. Kayan da aka kawo danshi a wani maida hankali na tcid50na 5.00 X105/ ml.
Don tantance SARS-2-2 don nuna assay lokacin amfani da Asiva kai tsaye. A cikin wannan binciken kusan 50μl na kwayar cutar da aka zubar da shi da samfurin mara kyau.
Lod an ƙaddara a matakai uku:

1. Lod nuni

10-ninka dilutions na pirtutions na rashin lafiyar ƙwayar cuta an yi shi a cikin mara kyau Asiva kuma an sarrafa kowane nazari kamar yadda aka bayyana a sama. An gwada waɗannan dilutions a cikin Tafiya. Taro na nuna 3 na abubuwa 3 na biyu don neman layukan lod.

2. Lissafin lod

Biyar (5) Dilutions Dilutions aka yi da tcid50na 5.00 X102/ ml maida hankali a cikin mummunan yanayi a cikin binciken kamar yadda aka bayyana a sama. An gwada waɗannan dilutions a cikin Tafiya. Taron ya nuna maki 3 na abubuwa 3 na biyu don tabbatar da LOD.

3. Tabbatar da lod

Tcid maida hankali50na 2.50 X102/ An gwada dilawa na ML don jimlar ashirin (20). Aƙalla goma sha tara (19) na sakamakon ashirin (20) ya kasance tabbatacce.
Kammalawa:
Dangane da wannan gwajin maida hankali ne kamar:
Lod: tcid502.50 X102/ ml

b) Cross-reciye:

Overse-rectent of Na'ur'in Tsarin Tsarin SSA-Cov-2 Antigen Ricp da aka tantance gwaji iri-iri (10 cfu / ml) da mara kyau matrixes-ml) da mara kyau matrixs Tsarin Na'urar SARS SARS-COV-2 Antigen mai saurin gwajin.
An gwada kowane kwayoyin da kwayar cuta a cikin kai tsaye. Dangane da bayanan da aka samar ta hanyar wannan binciken, na'urar tsarin tsarin, mai ƙarfi don gwajin ƙwayar SARS-2.

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c) tsoma baki:

Za a iya samun yiwuwar shiga cikin hadewar COV-2 SARS-2 An tantance gwajin abubuwa daban-daban tare da maida hankali a ƙasa gwajin ƙarfi na gaba. An gwada kowane abu a cikin Tafiya. Dangane da bayanan da aka kirkira ta wannan binciken, SARS ERVEP® SARS-2 Antigen da aka gwada da sauri da aka gwada.

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d) tasirin ƙugiya

Mafi girman taro na zafi-cov-2 stock 2 akwai (tcid50na 5.00 x 105/ An gwada. Babu wani sakamakon da aka gano.

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