Opanga ndi ogulitsa makaseti a Antigen Rapid Test Cassette (Colloidal Gold) yogulitsa COVID-19 |HEO

COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

Kufotokozera Kwachidule:

Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

[ZOFUNIKA KUGWIRITSA NTCHITO]
Kaseti ya COVID-19 Antigen Rapid Test Cassette (Saliva) ndi lateral flow immunoassay yopangidwira kuzindikira zamtundu wa SARS-CoV-2 nucleocapsid antigens m'malovu kuchokera kwa anthu omwe akuwaganizira kuti ali ndi COVID-19 ndi othandizira awo azaumoyo.
Zotsatira ndizomwe zimadziwika ndi SARS-CoV-2 nucleocapsid antigen.Antigen nthawi zambiri imapezeka m'malovu panthawi yovuta kwambiri ya matenda.Zotsatira zabwino zimasonyeza kukhalapo kwa tizilombo toyambitsa matenda, koma mgwirizano wachipatala ndi mbiri ya odwala ndi zina zowunikira ndizofunikira kuti mudziwe momwe matenda alili.Zotsatira zabwino sizimaletsa matenda a bakiteriya kapena kupatsirana ndi ma virus ena.Wothandizira wapezeka sangakhale wotsimikizika woyambitsa matenda.
Zotsatira zoyipa sizimaletsa matenda a SARS-CoV-2 ndipo siziyenera kugwiritsidwa ntchito ngati maziko okha a chithandizo kapena zisankho zowongolera odwala, kuphatikiza zisankho zowongolera matenda.Zotsatira zoyipa ziyenera kuganiziridwa potengera zomwe wodwala wakumana nazo posachedwa, mbiri yakale komanso kupezeka kwa zizindikiro zachipatala zomwe zimagwirizana ndi COVID-19, ndikutsimikiziridwa ndi kuyesa kwa maselo, ngati kuli kofunikira pakuwongolera odwala.
Makaseti a COVID-19 Antigen Rapid Test Cassette (Mate) amapangidwa kuti agwiritsidwe ntchito ndi akatswiri azachipatala kapena ogwira ntchito ophunzitsidwa bwino omwe ali ndi luso loyesa mayeso a lateral.Chogulitsacho chingagwiritsidwe ntchito kumalo aliwonse a labotale komanso omwe si a labotale omwe amakwaniritsa zofunikira zomwe zafotokozedwa mu Malangizo Ogwiritsa Ntchito ndi malamulo akumaloko.
[CHIDULE]
Novel coronaviruses (SARS-CoV-2) ndi amtundu wa p.COVID-19 ndi matenda opatsirana pachimake kupuma.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 yoyamwitsa 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.
[MFUNDO]
Kaseti ya COVID-19 Antigen Rapid Test Cassette (Saliva) ndi lateral flow immunoassay kutengera mfundo ya sangweji ya ma antibody awiri.SARS-CoV-2 nucleocapsid protein monoclonal antibody yolumikizidwa ndi ma microparticles amtundu amagwiritsidwa ntchito ngati chojambulira ndikupopera pa conjugation pad.Pakuyesa, ma antigen a SARS-CoV-2 pachitsanzo amalumikizana ndi ma anti-SARS-CoV-2 ophatikizidwa ndi ma microparticles amitundu omwe amapanga antigen-antibody olembedwa kuti ndizovuta.Zovutazi zimasuntha pa nembanemba kudzera pa capillary action mpaka mzere woyeserera, pomwe udzagwidwa ndi SARS-CoV-2 nucleocapsid protein monoclonal antibody.Mzere woyesera wamitundu (T) ukhoza kuwoneka pazenera lazotsatira ngati ma antigen a SARS-CoV-2 alipo pachitsanzocho.Kusakhalapo kwa mzere wa T kukuwonetsa zotsatira zoyipa.Mzere wowongolera (C) umagwiritsidwa ntchito poyang'anira njira, ndipo uyenera kuwonekera nthawi zonse ngati mayesowo achitidwa moyenera.
[CHENJEZO NDI CHENJEZO]
•Kugwiritsa ntchito mu vitro diagnostic kokha.
• Kwa akatswiri azaumoyo ndi anthu omwe aphunzitsidwa m'malo osamalira.
•Musagwiritse ntchito mankhwalawa ngati njira yokhayo yodziwira kapena kusapatula
Matenda a SARS-CoV-2 kapena kudziwitsa za matenda a COVID-19.
•Musagwiritse ntchito mankhwalawa tsiku litatha.
•Chonde werengani zonse zomwe zili mu kapepalaka musanapange mayeso.
•Kaseti yoyesera ikhalebe muthumba lomata mpaka itagwiritsidwa ntchito.
•Zitsanzo zonse ziyenera kuonedwa ngati zowopsa ndikusamalidwa mofanana ndi mankhwala opatsirana.
•Kaseti yoyeserera yomwe yagwiritsidwa ntchito iyenera kutayidwa molingana ndi malamulo aboma, boma komanso mdera lanu.
[COMPOSITION]
Zida Zoperekedwa
• Makaseti Oyesa: kaseti iliyonse yokhala ndi desiccant m'thumba lazojambulazo
• Zida Zotulutsa: Ampoule yomwe ili ndi 0.3 ml ya reagent yotulutsa
•Otolera Malovu
•Machubu otolera
•Madontho
• Phukusi Lowetsani
Zinthu Zofunika Koma Zosaperekedwa
• Chowerengera nthawi
[KUSINTHA NDI KUKHALA]
•Sungani monga mwa phukusi lomata pa kutentha (4-30°C kapena 40-86T).Zidazi ndi zokhazikika mkati mwa tsiku lotha ntchito lomwe lidasindikizidwa.
•Mukatsegula thumba, kuyezetsa kumayenera kugwiritsidwa ntchito pasanathe ola limodzi.Kusungidwa kwanthawi yayitali kumalo otentha ndi achinyezi kungayambitse kuwonongeka kwa zinthu.
•LOT ndi tsiku lotha ntchito zidasindikizidwa pa malembo.
[KUSONKHANITSA KOMANSO KUKONZERA ZINTHU]
OSATIKIKA kalikonse mkamwa kuphatikizapo chakudya, zakumwa, chingamu kapena fodya kwa mphindi zosachepera 30 kuti mutolere.
Gwiritsani ntchito chubu chotolera ndi malovu kuti mutenge malovu.Lowetsani chotolera malovu mu chubu chotolera, kenako ikani malovuwo pafupi ndi milomo ndikusiya malovuwo alowe mu chubu chotolera.Kuchuluka kwa malovu kuyenera kukhala pa sikelo (pafupifupi.300|jL).Ngati malovu ndi ochuluka, gwiritsani ntchito dontho kuti muchotse malovu ochulukirapo mpaka kutha kwa sikelo (pafupifupi 300pL).[ZOFUNIKA KUGWIRITSA NTCHITO]
Kaseti ya COVID-19 Antigen Rapid Test Cassette (Saliva) ndi lateral flow immunoassay yopangidwira kuzindikira zamtundu wa SARS-CoV-2 nucleocapsid antigens m'malovu kuchokera kwa anthu omwe akuwaganizira kuti ali ndi COVID-19 ndi othandizira awo azaumoyo.
Zotsatira ndizomwe zimadziwika ndi SARS-CoV-2 nucleocapsid antigen.Antigen nthawi zambiri imapezeka m'malovu panthawi yovuta kwambiri ya matenda.Zotsatira zabwino zimasonyeza kukhalapo kwa tizilombo toyambitsa matenda, koma mgwirizano wachipatala ndi mbiri ya odwala ndi zina zowunikira ndizofunikira kuti mudziwe momwe matenda alili.Zotsatira zabwino sizimaletsa matenda a bakiteriya kapena kupatsirana ndi ma virus ena.Wothandizira wapezeka sangakhale wotsimikizika woyambitsa matenda.
Zotsatira zoyipa sizimaletsa matenda a SARS-CoV-2 ndipo siziyenera kugwiritsidwa ntchito ngati maziko okha a chithandizo kapena zisankho zowongolera odwala, kuphatikiza zisankho zowongolera matenda.Zotsatira zoyipa ziyenera kuganiziridwa potengera zomwe wodwala wakumana nazo posachedwa, mbiri yakale komanso kupezeka kwa zizindikiro zachipatala zomwe zimagwirizana ndi COVID-19, ndikutsimikiziridwa ndi kuyesa kwa maselo, ngati kuli kofunikira pakuwongolera odwala.
Makaseti a COVID-19 Antigen Rapid Test Cassette (Mate) amapangidwa kuti agwiritsidwe ntchito ndi akatswiri azachipatala kapena ogwira ntchito ophunzitsidwa bwino omwe ali ndi luso loyesa mayeso a lateral.Chogulitsacho chingagwiritsidwe ntchito kumalo aliwonse a labotale komanso omwe si a labotale omwe amakwaniritsa zofunikira zomwe zafotokozedwa mu Malangizo Ogwiritsa Ntchito ndi malamulo akumaloko.
[CHIDULE]
Novel coronaviruses (SARS-CoV-2) ndi amtundu wa p.COVID-19 ndi matenda opatsirana pachimake kupuma.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 yoyamwitsa 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.
[MFUNDO]
Kaseti ya COVID-19 Antigen Rapid Test Cassette (Saliva) ndi lateral flow immunoassay kutengera mfundo ya sangweji ya ma antibody awiri.SARS-CoV-2 nucleocapsid protein monoclonal antibody yolumikizidwa ndi ma microparticles amtundu amagwiritsidwa ntchito ngati chojambulira ndikupopera pa conjugation pad.Pakuyesa, ma antigen a SARS-CoV-2 pachitsanzo amalumikizana ndi ma anti-SARS-CoV-2 ophatikizidwa ndi ma microparticles amitundu omwe amapanga antigen-antibody olembedwa kuti ndizovuta.Zovutazi zimasuntha pa nembanemba kudzera pa capillary action mpaka mzere woyeserera, pomwe udzagwidwa ndi SARS-CoV-2 nucleocapsid protein monoclonal antibody.Mzere woyesera wamitundu (T) ukhoza kuwoneka pazenera lazotsatira ngati ma antigen a SARS-CoV-2 alipo pachitsanzocho.Kusakhalapo kwa mzere wa T kukuwonetsa zotsatira zoyipa.Mzere wowongolera (C) umagwiritsidwa ntchito poyang'anira njira, ndipo uyenera kuwonekera nthawi zonse ngati mayesowo achitidwa moyenera.
[CHENJEZO NDI CHENJEZO]
•Kugwiritsa ntchito mu vitro diagnostic kokha.
• Kwa akatswiri azaumoyo ndi anthu omwe aphunzitsidwa m'malo osamalira.
•Musagwiritse ntchito mankhwalawa ngati njira yokhayo yodziwira kapena kusapatula
Matenda a SARS-CoV-2 kapena kudziwitsa za matenda a COVID-19.
•Musagwiritse ntchito mankhwalawa tsiku litatha.
•Chonde werengani zonse zomwe zili mu kapepalaka musanapange mayeso.
•Kaseti yoyesera ikhalebe muthumba lomata mpaka itagwiritsidwa ntchito.
•Zitsanzo zonse ziyenera kuonedwa ngati zowopsa ndikusamalidwa mofanana ndi mankhwala opatsirana.
•Kaseti yoyeserera yomwe yagwiritsidwa ntchito iyenera kutayidwa molingana ndi malamulo aboma, boma komanso mdera lanu.
[COMPOSITION]
Zida Zoperekedwa
• Makaseti Oyesa: kaseti iliyonse yokhala ndi desiccant m'thumba lazojambulazo
• Zida Zotulutsa: Ampoule yomwe ili ndi 0.3 ml ya reagent yotulutsa
•Otolera Malovu
•Machubu otolera
•Madontho
• Phukusi Lowetsani
Zinthu Zofunika Koma Zosaperekedwa
• Chowerengera nthawi
[KUSINTHA NDI KUKHALA]
•Sungani monga mwa phukusi lomata pa kutentha (4-30°C kapena 40-86T).Zidazi ndi zokhazikika mkati mwa tsiku lotha ntchito lomwe lidasindikizidwa.
•Mukatsegula thumba, kuyezetsa kumayenera kugwiritsidwa ntchito pasanathe ola limodzi.Kusungidwa kwanthawi yayitali kumalo otentha ndi achinyezi kungayambitse kuwonongeka kwa zinthu.
•LOT ndi tsiku lotha ntchito zidasindikizidwa pa malembo.
[KUSONKHANITSA KOMANSO KUKONZERA ZINTHU]
OSATIKIKA kalikonse mkamwa kuphatikizapo chakudya, zakumwa, chingamu kapena fodya kwa mphindi zosachepera 30 kuti mutolere.
Gwiritsani ntchito chubu chotolera ndi malovu kuti mutenge malovu.Lowetsani chotolera malovu mu chubu chotolera, kenako ikani malovuwo pafupi ndi milomo ndikusiya malovuwo alowe mu chubu chotolera.Kuchuluka kwa malovu kuyenera kukhala pa sikelo (pafupifupi.300|jL).Ngati malovu ndi ochuluka, gwiritsani ntchito dontho kuti muchotse malovu ochulukirapo mpaka kutha kwa sikelo (pafupifupi 300pL).

Zitsanzo Zoyendera ndi Kusungirako

Zitsanzo zomwe zangotengedwa kumene ziyenera kukonzedwa posachedwa, koma pasanathe ola limodzi chitsanzo chatoleredwa.

[NJIRA YOYESA]

Zindikirani: Lolani makaseti oyesera, ma reagents ndi zitsanzo kuti zifanane ndi kutentha kwa chipinda (15-30 ° C kapena 59-86T) musanayesedwe.

Ikani chubu chotolera ndi malovu omwe ali ndi malovu pamalo ogwirira ntchito.Chotsani chivindikiro cha reagent yochotsa.Onjezerani ma reagents onse mu chubu chosonkhanitsira.

Tayani malovu;Phimbani chubu chotolera ndi nsonga yodontha pa chubu chotolera.Gwirani chubu chosonkhanitsira mopitilira katatu mwamphamvu kusakaniza malovu ndi reagent yochotsa, kenaka sungani njira yosakanikirana kakhumi kuti malovu asakanizidwe bwino.

Chotsani makaseti oyesera m'thumba lomata.

Sinthani chubu chosonkhanitsira, gwira chubu mowongoka, sinthani madontho atatu (pafupifupi 100pL) pang'onopang'ono kupita pachitsime cha chitsanzo (S) cha makaseti oyeserera, kenako yambani chowerengera.

Yembekezerani kuti mizere yamitundu iwonekere.Tanthauzirani zotsatira za mayeso pa mphindi khumi ndi zisanu.Osawerenga zotsatira pakadutsa mphindi 20.

[KUMASULIRIDWA KWA ZOTSATIRA]
Zabwino \|	§	Mizere iwiri ikuwonekera.Mzere umodzi wachikuda umawoneka H c pagawo lolamulira (C), ndipo wina wachikuda Jt\|jne amawonekera pagawo loyesa (T), mosasamala kanthu za kukula kwa mzere woyesera.
Zoipa		Mzere umodzi wachikuda umapezeka pamalo olamulira (C), ndipo palibe mzere womwe umapezeka pagawo loyesa (T).
Zosalondola		Mzere wowongolera ukulephera kuwonekera.Zosakwanira,Voliyumu yachitsanzo kapena njira zolakwika 5 ndizomwe zimapangitsa kuti mzere wa c ulephereke.Onani ndondomekoyi ndi Jtbwerezani mayeso pogwiritsa ntchito kaseti yatsopano yoyesera.NgatiJ)vuto likupitirirabe, siyani kugwiritsa ntchito maere nthawi yomweyo ndipo funsani wogawa wakomweko.

[KUKHALA KWAKHALIDWE]

Kuwongolera kwadongosolo kumaphatikizidwa muyeso.Mzere wachikuda womwe ukuwoneka m'chigawo chowongolera (C) umatengedwa ngati njira yoyendetsera mkati.Imatsimikizira kuchuluka kokwanira kwa sampuli, kupukuta kokwanira kwa membrane ndi njira yoyenera.

Zowongolera siziperekedwa ndi zida izi.Komabe, tikulimbikitsidwa kuti zowongolera zabwino ndi zoyipa ziyesedwe ngati machitidwe abwino a labotale kuti atsimikizire njira yoyezetsa komanso kuyeserera koyenera.

[MALIRE]

Chogulitsacho chili ndi malire kuti chidziwike bwino.Kuchuluka kwa mzere woyesera sikumayenderana ndi kuchuluka kwa ma antigen a zitsanzo.
Zotsatira zoyipa siziletsa kutenga kachilombo ka SARS-CoV-2 ndipo siziyenera kugwiritsidwa ntchito ngati maziko okhawo pazosankha zowongolera odwala.
Dokotala ayenera kutanthauzira zotsatira zake mogwirizana ndi mbiri ya wodwalayo, zomwe apeza, ndi njira zina zowunikira.
Chotsatira choyipa chitha kuchitika ngati kuchuluka kwa ma antigen a SARS-CoV-2 omwe ali pachitsanzo ali pansi pa gawo loyesera, kapena kachilomboka kakhala kakusintha pang'ono amino acid m'chigawo cha epitope chomwe chimadziwika ndi ma antibodies a monoclonal. zogwiritsidwa ntchito muyeso.

[ZINTHU ZOCHITIKA]

Magwiridwe Achipatala

Ntchito yachipatala ya COVID-19 Antigen Rapid Test Cassette (Saliva) idakhazikitsidwa m'maphunziro omwe akuyembekezeka ndi zitsanzo zotengedwa kuchokera kwa odwala 628 omwe ali ndi zizindikiro (m'masiku 7 okha) komanso odwala omwe akuwaganizira kuti ali ndi COVID-19.

Chidule cha Mayeso a COVID-19 Antigen Rapid monga pansipa:

The RT-PCR cycle threshold (Ct) ndiye chizindikiro choyenera.Kutsika kwa Ct kumawonetsa kuchuluka kwa ma virus.Kukhudzika kunawerengeredwa pamitundu yosiyanasiyana ya mtengo wa Ct (Ct valueW37)

Antfgeno COVID-19		RT-PCR		Zonse
Antfgeno COVID-19		Positivo	Negativo	Zonse
HEO®	Positivo	172	0	172
HEO®	Negativo	3	453	456
Zonse		175	453	628

Mgwirizano Wabwino Paperesenti(PPA)=98.28%(172/175),(95%CI:95.08%~99.41%)

Mgwirizano Wopanda Malire (NPA)=100%(453/453),(95%CI:99.15%~100%)

PPA - Mgwirizano Wabwino Paperesenti (Kukhudzidwa)

NPA - Pangano Lopanda Maperesenti (Kukhazikika)

Malire Ozindikira (Kukhudzidwa Kwambiri)

Kafukufukuyu adagwiritsa ntchito kachilombo koyambitsa matenda a SARS-CoV-2 (Isolate Hong Kong/ VM20001061/2020, NR-52282), yomwe imakhala yosasunthika ndikulowa m'malovu.Malire a Kuzindikira (LoD) ndi 8.6 X10²TCIDso/mL.

Cross Reactivity (Analytical Specificity)

Cross reactivity idawunikidwa poyesa ma 32 commensal ndi tizilombo toyambitsa matenda omwe angakhalepo mu oralcavity.

Palibe mtanda-reactivity unkawonedwa ndi recombinant MERS-CoV NP mapuloteni pamene anayesedwa pa ndende ya 50 pg/mL.

Palibe cross-reactivity yomwe idawonedwa ndi ma virus otsatirawa atayesedwa pandende ya 1.0x10⁶PFU/mL: Influenza A (H1N1), Chimfine A

(H1N1 pdm09), Influenza A(H3N2), Fuluwenza B(Yamagata), Influenza B(Victoria), Adenovirus (mtundu 1, 2, 3, 5, 7, 55), Human metapneumovirus, Parainfluenza virus (mtundu 1,2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

Palibe mabakiteriya otsatirawa omwe adawonedwa ndi mabakiteriya otsatirawa atayesedwa pa kuchuluka kwa 1.0x10' CFU/mL: Mycoplasma pneumoniae, Chlamy dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (gulu A), Streptococcus pneumoniae, Candida al. aureus.

Kusokoneza

Zinthu zotsatirazi zomwe zitha kusokoneza zidawunikidwa ndi COVID-19 Antigen Rapid Test Cassette (Mate) pazigawo zomwe zalembedwa pansipa ndipo zidapezeka kuti sizikhudza magwiridwe antchito a tegt.

Mankhwala	Kukhazikika	Mankhwala	Kukhazikika
Mucin	2%	Mwazi wonse	4%
Benzocaine	5 mg/mL	Menthol	10 mg/mL
Saline nasal spray	15%	Phenylephrine	15%
Oxymetazoline	15%	Histamine dihydrochloride	10 mg/mL
Tobramycin	5 p/ml	Mupirocin	10 mg/mL
Oseltamivir phosphate	10 mg/mL	Zanamivir	5 mg/mL
Arbidol	5 mg/mL	Ribavirin	5 mg/mL
Fluticasone propionate	5%	Dexamethasone	5 mg/mL
Triamcinolone	10 mg/mL

Mlingo waukulu wa Hook Effect

Kaseti ya COVID-19 Antigen Rapid Test Cassette (Saliva) idayesedwa mpaka 1.15x1 o' TCIDso/mL ya SARS-CoV-2 yosagwira ntchito ndipo palibe mbedza yamphamvu kwambiri yomwe idawonedwa.

Malingaliro a kampani Hangzhou Heo Technology Co., Ltd.

Address: Room201, Building3, No.2073 Jinchang Road,

Liangzhu Street, Yuhang District, Hangzhou, China Postcode: 311113

Tel:0086-571-87352763 Imelo:52558565@qq.com

Lotus NL BV Address:Koningin Julianaplein 10, le Verd,

2595AA, The Hague, Netherlands.Imelo:Peter@lotusnl.com

Tel:+31644168999

1.Chotsani swab mu phukusi.

2. Pendekerani mutu wa wodwala kumbuyo pafupifupi 70 °.

3.1-2Potembenuza pang'onopang'ono swab, ikani swab pafupifupi 2.5 cm (1 inchi) mumphuno mpaka kukana kukumane ndi ma turbinate.

4.Sungani swab kangapo ku khoma lamphuno ndikubwerezanso mumphuno ina pogwiritsa ntchito swab yomweyo.

Zitsanzo Zoyendera ndi Kusungirako

Osabwezera swab ku paketi yoyambirira ya swab.Zitsanzo zomwe zangotengedwa kumene ziyenera kukonzedwa posachedwa, koma pasanathe ola limodzi chitsanzo chatoleredwa.

NJIRA YOYESA

Zindikirani:Lolani makaseti oyesera, ma reagents ndi zitsanzo kuti zifanane ndi kutentha kwachipinda (15-30 ℃ kapena 59-86 ℉) musanayesedwe.

1.Ikani chubu chochotsa m'malo ogwirira ntchito.

2.Chotsani chosindikizira chosindikizira cha aluminiyamu pamwamba pa chubu chochotsa chomwe chili ndi chubu chochotsamo.

3.Sampling ikutanthauza gawo la 'Specimen Collection'.

4.Ikani chitsanzo cha swab ya m'mphuno mu chubu chochotsa chomwe chili ndi reagent yochotsa.Pereka swab osachepera kasanu ndikukankhira mutu pansi ndi mbali ya chubu chochotsa.Siyani swab ya m'mphuno mu chubu chochotsa kwa mphindi imodzi.

5.Chotsani swab ya m'mphuno kwinaku mukufinya mbali za chubu kuti mutenge madzi kuchokera ku swab.Yankho lochotsedwa lidzagwiritsidwa ntchito ngati chitsanzo choyesera.6.Kuphimba chubu chochotsa ndi dontho lachitsulo mwamphamvu.

7.Chotsani makaseti oyesera m'thumba lomata.

8.Sinthani chubu chotsitsa cha specimen, kugwira chubu molunjika, tumizani madontho a 3 (pafupifupi 100 μL) pang'onopang'ono ku chitsime cha chitsanzo (S) cha kaseti yoyesera, ndiye yambani chowerengera.

9.Dikirani kuti mizere yamitundu iwonekere.Tanthauzirani zotsatira za mayeso pa mphindi khumi ndi zisanu.Osawerenga zotsatira pakadutsa mphindi 20.

KUMASULIRIDWA KWA ZOTSATIRA

Zabwino

C T

Mizere iwiri ikuwonekera.Mzere umodzi wachikuda umawoneka wa mphamvu ya mzere woyesera.

Zoipa

Mzere umodzi wachikuda umapezeka pamalo olamulira (C), ndipo palibe mzere womwe umapezeka pagawo loyesa (T).

Zosalondola

C T

Kulamulira mzere amalephera to kuwonekera. Kusakwanira kwa kuchuluka kwa zitsanzo kapena njira zolakwika ndizo zifukwa zomwe zimalepheretsa mzere wowongolera.Unikaninso ndondomekoyi ndikubwereza kuyesanso pogwiritsa ntchito kaseti yatsopano yoyesera.Vuto likapitilira, siyani kugwiritsa ntchito maere nthawi yomweyo ndipo funsani wofalitsa wapafupipafupi.

KUKHALA KWAKHALIDWE

ZOPHUNZITSA

•Zogulitsazo zimangopereka chidziwitso chodziwika bwino.Kuchuluka kwa mzere woyesera sikumayenderana ndi kuchuluka kwa ma antigen a zitsanzo.

•Zotsatira zoyipa sizilepheretsa kutenga kachilombo ka SARS-CoV-2 ndipo ngati zizindikiro zilipo muyenera kufufuzanso nthawi yomweyo Kudzera pa Njira ya PCR.

•Dokotala ayenera kutanthauzira zotsatira zake mogwirizana ndi mbiri ya wodwalayo, zomwe wapeza, ndi njira zina zowunikira.

• Zotsatira zoyipa zomwe zapezedwa kuchokera ku Kit zikuyenera kutsimikiziridwa ndi PCR.Chotsatira choyipa chitha kuchitika ngati kuchuluka kwa ma antigen a SARS-CoV-2 omwe ali pachitsanzo ali pansi pa gawo loyesera, kapena kachilomboka kakhala kakusintha pang'ono amino acid m'chigawo cha epitope chomwe chimadziwika ndi ma antibodies a monoclonal. zogwiritsidwa ntchito muyeso.

•Magazi ochulukira kapena ntchofu pa swab akhoza kusokoneza kagwiritsidwe ntchito kake ndipo angapereke zotsatira zabodza.

ZINTHU ZOCHITIKA

Magwiridwe Achipatala

COVID-19 antigen		RT-PCR		Totale
COVID-19 antigen		Zabwino	Zoipa	Totale
HEO®	Zabwino	212	0	212
HEO®	Zoipa	3	569	572
Zonse		215	569	784

PPA =98.60% (212/215), (95%CI: 95.68%~99.71%) NPA =100% (569/569), (95%CI: 99.47%~100%)

PPA - Positive Percent Agreement (Sensitivity) NPA - Negative Percent Agreement (Specific) 95% *Zigawo Zachikhulupiriro

Masiku chiyambireni chizindikiro	RT-PCR	HEO TECHNOLOGY	Mgwirizano (%)
0-3	95	92	96.84%
4-7	120	120	100%

Mtengo wa CT	RT-PCR	HEO TECHNOLOGY	Mgwirizano (%)
Ct≤30	42	42	100%
Ct≤32	78	78	100%
Ct≤35	86	85	98.84%
＜37	9	7	77.78%

Malire Ozindikira (Kukhudzidwa Kwambiri)

Kafukufukuyu adagwiritsa ntchito kachilombo koyambitsa matenda a SARS-CoV-2, komwe sikumatenthedwa ndikulowa m'mphuno.Malire a Kuzindikira (LoD) ndi 1.0 × 102 TCID50/mL.

Cross Reactivity (Analytical Specificity)

Cross reactivity inayesedwa poyesa 32 commensal ndi tizilombo toyambitsa matenda zomwe zingakhalepo m'mphuno.Palibe mtanda-reactivity unkawonedwa ndi recombinant MERS-CoV NP mapuloteni pamene anayesedwa pa ndende ya 50 pg/mL.

Palibe ma virus omwe adawonedwa ndi ma virus otsatirawa atayesedwa pamlingo wa 1.0 × 106 PFU/mL: Fuluwenza A (H1N1), Influenza A (H1N1pdm09), Fuluwenza A (H7N9), Fuluwenza A (H3N2), Fuluwenza B ( Yamagata), Influenza B (Victoria), Adenovirus (mtundu 1, 2, 3, 5, 7, 55), Human metapneumovirus,

Parainfluenza virus (mtundu 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

Palibe mabakiteriya otsatirawa omwe adayesedwa pamlingo wa 1.0 × 107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (gulu A), Streptococcus pneumoniae, albicans Staphylococcus aureus.

Kusokoneza

Zinthu zotsatirazi zomwe zitha kusokoneza zidawunikidwa ndi COVID-19 Antigen Rapid Test Cassette (Nasal Swab) pazigawo zomwe zalembedwa pansipa ndipo zidapezeka kuti sizikhudza momwe mayeso akuyendera.

Mankhwala	Kukhazikika	Mankhwala	Kukhazikika
Mucin	2%	Mwazi wonse	4%
Benzocaine	5 mg/mL	Menthol	10 mg/mL
Saline nasal spray	15%	Phenylephrine	15%
Oxymetazoline	15%	Mupirocin	10 mg/mL
Tobramycin	5 μg/mL	Zanamivir	5 mg/mL
Oseltamivir phosphate	10 mg/mL	Ribavirin	5 mg/mL
Arbidol	5 mg/mL	Dexamethasone	5 mg/mL
Fluticasone propionate	5%	Histamine dihydrochloride	10 mg/mL
Triamcinolone	10 mg/mL	Histamine dihydrochloride	10 mg/mL

Mlingo waukulu wa Hook Effect

Kaseti ya COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) idayesedwa mpaka 1.0×10 5 TCID50 /mL ya SARS-CoV-2 yosagwira ntchito ndipo palibe mbedza yamphamvu kwambiri yomwe idawonedwa.

Mafunso Ofunsidwa Kawirikawiri

1.Kodi kuyesa kwa SARS-CoV-2 Antigen Rapid kumagwira ntchito bwanji?Mayesowa ndi ozindikira kuti ma antigen a SARS-CoV-2 ali m'zitsanzo zodzitolera zokha.Zotsatira zabwino zikuwonetsa ma antigen a SARS-CoV-2 omwe amapezeka pachitsanzocho.

Kodi mayesowo agwiritsidwe ntchito liti?

SARS-CoV-2 antigen amatha kudziwika pachimake kupuma thirakiti matenda, tikulimbikitsidwa kuthamanga mayeso pamene zizindikiro kuphatikizapo mwadzidzidzi isanayambike chimodzi mwa zotsatirazi: chifuwa, kutentha thupi, kupuma movutikira, kutopa, kuchepa chilakolako, myalgia.

Kodi zotsatira zake zingakhale zolakwika?

Zotsatira zake ndi zolondola malinga ndi malangizo omwe amalemekezedwa mosamala.Komabe, zotsatira zake zitha kukhala zolakwika ngati sampling volume yosakwanira kapena SARS-CoV-2 Antigen Rapid Test inyowa mayeso asanayesedwe, kapena ngati kuchuluka kwa madontho ocheperako ndi osakwana 3 kapena kupitilira 4. Kupatula apo, chifukwa cha mfundo za immunological okhudzidwa, pali mwayi wa zotsatira zabodza nthawi zina.Kukambirana ndi dokotala nthawi zonse kumalimbikitsidwa paziyeso zotere zochokera ku mfundo za immunological.

Momwe mungatanthauzire mayeso ngati mtundu ndi kukula kwa mizere ndizosiyana?Mtundu ndi mphamvu ya mizere ilibe kufunikira pakutanthauzira zotsatira.Mizere iyenera kukhala yofanana komanso yowonekera bwino.Chiyesocho chiyenera kuonedwa ngati chabwino, kaya ndi mtundu wamtundu wanji wa mzere woyesera.5.Kodi ndiyenera kuchita chiyani ngati zotsatira zake zili zopanda pake?

Zotsatira zoyipa zikutanthauza kuti mulibe kachilombo kapena kuti kuchuluka kwa ma virus ndikotsika kwambiri

kuti azindikiridwe ndi mayeso.Komabe, ndizotheka kuti mayesowa apereke zotsatira zolakwika zomwe sizolondola (zabodza) mwa anthu ena omwe ali ndi COVID-19.Izi zikutanthauza kuti mutha kukhalabe ndi COVID-19 ngakhale mayeso alibe.

Ngati mukukumana ndi zizindikiro monga kupweteka kwa mutu, mutu waching'alang'ala, kutentha thupi, kutaya fungo ndi kukoma, funsani kuchipatala chapafupi pogwiritsa ntchito malamulo a boma lanu.Kuphatikiza apo, mutha kubwereza mayesowo ndi zida zatsopano zoyeserera.Ngati mukukayikira, bwerezani mayesowo patatha masiku 1-2, chifukwa coronavirus siyingadziwike m'magawo onse a matenda.Malamulo a mtunda ndi ukhondo ayenera kuwonedwabe.Ngakhale zotsatira zoyipa zitayesedwa, malamulo a mtunda ndi ukhondo ayenera kutsatiridwa, kusamuka/kuyendayenda, kupita ku zochitika ndi zina zotero ziyenera kutsatira malangizo/zofunikira za COVID kwanuko.6.Kodi ndiyenera kuchita chiyani ngati zotsatira zake zili zabwino?

Zotsatira zabwino zikutanthauza kukhalapo kwa ma antigen a SARS-CoV-2.Zotsatira zabwino zikutanthauza kuti ndizotheka kuti muli ndi COVID-19.Nthawi yomweyo dzipatuleni molingana ndi malangizo amdera lanu ndipo funsani sing'anga / dokotala kapena dipatimenti yazaumoyo mdera lanu malinga ndi malangizo a aboma amdera lanu.Zotsatira zanu zidzawunikidwa ndi kuyesa kotsimikizira kwa PCR ndipo mudzafotokozedwa masitepe otsatirawa.