Ubuhumekero bwo gupima ubuhumekero - Ibicurane byinshi / COVID / RSV Panel OEM Utanga

Ibicuruzwa

Inzira Yubuhumekero Yumwanya

Kuva kumurongo umwe - intego yerekana kugeza kuri 4 - muri - 1 cassettes ya multiplex yagenewe kwandura indwara yimbeho.

Respiratory Multiple Rapid Test (FluA /FluB/COVID-19/RSV/Adeno/MP/HMPV)

Ubuhumekero Bwinshi Bwihuta (FluA / FluB / COVID - 19 / RSV / Adeno / MP / HMPV)

Intego:FluA / FluB / COVID - 19 / RSV / Adeno / MP / HMPV

Icyitegererezo:oropharyngeal cyangwa nasopharyngeal swab

CE IVDR ISO 13485

Respiratory Multiple Rapid Test (FluA/FluB/COVID-19/RSV)

Ubuhumekero Bwinshi Bwihuta (FluA / FluB / COVID - 19 / RSV)

Intego:FluA / FluB / COVID - 19 / RSV

Icyitegererezo:oropharyngeal cyangwa nasopharyngeal swab

CE IVDR ISO 13485

Novel Coronavirus (COVID-19) IgM IgG Antibody Combo Test Kit (Colloidal Gold)

Novel Coronavirus (COVID - 19) IgM IgG Antibody Combo Ikizamini Cyiza (Zahabu ya Colloidal)

Intego:Ibishya Coronavirus (COVID - 19) IgM IgG Antibody

Icyitegererezo:plasma / serumu / amaraso yose

CE IVDR ISO 13485

COVID-19 and Influenza A/B Antigen Test Kit

COVID - 19 hamwe na Grippe A / B Ikizamini cya Antigen

Intego:FluA / FluB / COVID - 19

Icyitegererezo:oropharyngeal cyangwa nasopharyngeal swab

CE IVDR ISO 13485

Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

Ibishya Coronavirus (COVID - 19) Igikoresho cyo gupima Antigen (Zahabu ya Colloidal)

Intego:Agashya Coronavirus (COVID - 19) Antigen

Icyitegererezo:oropharyngeal cyangwa nasopharyngeal swab

CE IVDR ISO 13485

Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) – Nasopharyngeal,oropharyngeal

Ibishya Coronavirus (COVID - 19) Ikizamini cya Antigen (Zahabu ya Colloidal) - Nasopharyngeal, oropharyngeal

Intego:Agashya Coronavirus (COVID - 19) Antigen

Icyitegererezo:oropharyngeal cyangwa nasopharyngeal swab

CE IVDR ISO 13485

LYHER Novel coronavirus (COVID-19) Antigen test kit (Colloidal Gold)

LYHER Novel coronavirus (COVID - 19) Ibikoresho byo gupima Antigen (Zahabu ya Colloidal)

Intego:Agashya coronavirus (COVID - 19) Antigen

Icyitegererezo:amacandwe

CE IVDR ISO 13485

Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) for self-testing

Novel Coronavirus (COVID - 19) Ikizamini cya Antigen (Zahabu ya Colloidal) yo kwikorera - kwipimisha

Intego:Agashya Coronavirus (COVID - 19) Antigen

Icyitegererezo:izuru

CE IVDR ISO 13485

SARS-CoV-2 Antigen Rapid Test Kit for self-testing (Saliva)

SARS - CoV - 2 Antigen Yihuta Yibikoresho byo Kwipimisha - kwipimisha (Amacandwe)

Intego:SARS - CoV - 2 Antigen

Icyitegererezo:Amacandwe

CE IVDR ISO 13485

Ibyerekeye Uru Rwego

Akanama gashinzwe guhumeka ni iki?

AAkanama k'ubuhumekeroni multiplex Ingingo - ya - Kwipimisha Kwitaho (POCT) igamije kumenya vuba no gutandukanya virusi zubuhumekero na bagiteri zisanzwe hamwe numurwayi umwe.

Kubera ko indwara zifata imyanya y'ubuhumekero nka COVID - 19, ibicurane, na RSV zisangiye ibimenyetso by’indwara (umuriro, inkorora, umunaniro), ibizamini byihuse byita ku buzima byita ku buzima kugira ngo bamenye vuba indwara yanduye, bahitemo imiti igabanya ubukana bwa virusi, kandi birinde icyorezo cya nosocomial.

Uburyo bwo Kumenya

Zahabu ya Colloidal (LFIA) cyangwa Fluorescence Immunoassay. Gutanga ibisubizo bisobanutse, bigaragara kumirongo myinshi yikizamini muminota 10 - 15.

Ubwoko bw'icyitegererezo

Nasopharyngeal Swab, Imbere ya Nasal Swab, cyangwa Oropharyngeal Swab bitewe na cassette yihariye.

Intego z'ingenzi

SARS - CoV - 2 (COVID - 19), ibicurane A & B, Virusi Syncytial Virus (RSV), Adenovirus, na Mycoplasma pneumoniae.

Ubuyobozi bwa Tekinike

Uburyo busanzwe bwo kugerageza

Byoroshye, 4 - intambwe yihuta protocole. Nta bikoresho bya laboratoire bisabwa. Nyamuneka ohereza kuri IFU yihariye yashyizwe mubikoresho byawe.

Kusanya Ingero

Shyiramo sterile swab mu mazuru yumurwayi (cyangwa nasofarynx) hanyuma uzenguruke witonze kugirango ukusanye urugero rwa antigen ihagije.

Kuramo Antigen

Shira swab mumashanyarazi yo gukuramo. Shira kandi uzenguruke swab ushikamye kurukuta rwa tube kugirango urekure antigene.

Saba Cassette

Kuraho swab hanyuma ushireho igitonyanga. Ongeraho ibitonyanga 3 byicyitegererezo cyakemuwe muri buri sample neza (S) kuri cassette ya multiplex.

Soma ibisubizo

> Tegereza nezaIminota 15. Umurongo kuri 'C' wemeza ikizamini cyemewe. Imirongo kuri 'T' (urugero, ibicurane A, ibicurane B, COVID) yerekana ibisubizo byiza.

Ikoranabuhanga

Ikoranabuhanga rya Zahabu Immunochromatographic Ikoranabuhanga

Indwara z'ubuhumekero ibikoresho byihuta byipimisha bishingiye kuri tekinoroji ya zahabu ya immunochromatographic assay, uburyo bukoreshwa cyane mugupima imigezi kugirango hamenyekane vuba indwara ziterwa n'ubuhumekero. Iri koranabuhanga rifasha gusobanura byihuse, gukora byoroshye, hamwe ningingo yizewe - ya - gupima ubuvuzi bwindwara zubuhumekero zanduye zirimo COVID - 19, ibicurane A / B, na RSV.

⚡

Ibisubizo Byihuse

Ibisubizo bifatika byo kwisuzumisha muminota 10 - 15, ingenzi kuri ER n'amavuriro.

🔬

Kumva neza

Yakozwe muburyo bwo gusesengura ibintu byinshi muburyo busanzwe bwa virusi.

🛡

Ihinduka ryiza cyane

24 - ukwezi kuramba hamwe nibikorwa bihoraho mubushyuhe bwicyumba (2 - 30 ° C).

👁

Ibisobanuro bigaragara

Byoroshye - to - gusoma imirongo yamabara ikuraho ibikenerwa ibikoresho bihenze.

✅

Igikorwa cyoroshye

Imwe - intambwe ikurikira itembera protocole, itunganijwe kubintu - bya - ibidukikije byitaweho.

🌍

Umusaruro rusange

Imirongo ikora yimashini itanga ubwinshi bwogutanga isi yose.

Kubahiriza amabwiriza

Impamyabumenyi & Ibyemezo byemewe

Ibikoresho byubuhumekero byubuhumekero bikozwe muburyo bwemewe bwo gucunga neza kandi bigasukurwa ku masoko akomeye ku isi.

Icyemezo cya ISO 13485

Icyemezo cya ISO 9001

Icyemezo cya MDSAP

Burezili ANVISA BGMP

Koresha Imanza

Ibizamini byubuhumekero bikoreshwa he?

Yashizweho kugirango ashyigikire protocole yo kurwanya indwara mu nzego zose z’ibikorwa remezo byubuzima.

Ibitaro & ER Tage

Menya vuba kandi utandukanye abarwayi banduye kugirango wirinde umusaraba - kwanduza mu byumba byo gutegereza byihutirwa

Ubuvuzi bw'abana & Ubuvuzi bw'ibanze

Menya neza virusi itera virusi yumwana mugihe kimwe, uyobora imiti ikwiye.

Farumasi & OTC

Tanga uburyo bworoshye - kwipimisha ibimamara kugirango umenye hakiri kare murugo, kugabanya ikwirakwizwa ryabaturage.

Amashuri & Akazi

Kwipimisha cyane mugihe cyimbeho kugirango ibungabunge umutekano wibikorwa byuburezi.

Inkunga & Serivisi

Ibibazo Bikunze Kubazwa & Ibisubizo

Ikizamini gishobora gutandukanya ibicurane A / B na COVID - 19?

Yego. Cassettes yikizamini cya combo igaragaramo imirongo yikizamini itandukanye (urugero, T1 kuri COVID - 19, T2 kuri ibicurane A, T3 kuri ibicurane B), itanga itandukaniro risobanutse nicyitegererezo kimwe cya swab muminota 15.

Ni ubuhe buzima bwo kubika ibikoresho byubuhumekero byihuse?

Ibikoresho byacu bifite ubuzima bubi bwaAmezi 24guhera umunsi byakorewe iyo bibitswe neza mumifuka yabo ifunze mubushyuhe bwicyumba (2-30 ° C / 36–86 ° F). Irinde gukonjesha no kuyobora izuba.

Ibi bikoresho bigenewe gukoreshwa mubuhanga cyangwa murugo wenyine - kwipimisha?

Dukora imiterere yombi. Umwuga - koresha ibikoresho byabugenewe kubitaro n'amavuriro (akenshi ukoresha ibinini byimbitse bya nasofaryngeal). Turatanga kandi CE yihariye - Yemerewe OTC (Kurenga - The - Counter) wenyine - verisiyo yikizamini ukoresheje ubwitonzi bwimbere bwizuru.

Ibisubizo Byambere byo Gukora

Witegure igihe cyibicurane ufatanya nu ruganda rwa IVD. Dutanga iherezo - to - kurangiza kugenera ikirango cyawe cyo gusuzuma, kwemeza kwihuta kwisoko no kubahiriza amategeko.

Ikoreshwa rya Multiplex

Huza ibipimo byihariye (urugero, SARS - CoV - 2 + ibicurane A / B + RSV + ADV) muri kimwe 3 - muri - 1, 4 - muri - 1, cyangwa 5 - muri - 1 cassette yikizamini ukurikije ibyifuzo byawe byo mu karere.

Ikirango cyihariye & Gupakira

Serivise yuzuye yubukorikori bwa pouches, byinshi - ururimi IFU yinjiza (Amabwiriza yo Gukoresha), hamwe namakarito yo kugurisha yo hanze ajyanye nibiranga ikirango cyawe.

Inkunga yo Gutanga Amabwiriza

Dutanga ibyangombwa bya tekiniki byuzuye, ubushakashatsi bwo kwemeza imikorere, hamwe namakuru yubuvuzi kugirango twihutishe Minisiteri yubuzima y’ibanze cyangwa CE IVDR kwiyandikisha.

Menyesha