ʻO ka mea i hala iho nei, ua hoʻokumu ʻo Pluslife Biotech, kahi ʻoihana i hoʻokumu ʻia ma Greater Bay Area, i ka Covid-19 Nucleic Acid Test paʻa lima e kōkua i ka pale ʻana a me ka hoʻomalu ʻana.
Ua hōʻeha nui ʻia ʻo Hong Kong e ka nalu hou o nā maʻi COVID-19 i nā pule i hala. I ka pane ʻana i nā paʻakikī me ka nele o ke kanaka no ka pale ʻana a me ka hoʻomalu ʻana i ka maʻi maʻi, a me ka palena o ka hoʻāʻo ʻana, ua ʻōwili ke aupuni Hong Kong SAR i kahi papahana ākea, ka hāʻawi ʻana i nā pahu hoʻāʻo a ʻae i ka poʻe noho e hoʻāʻo iā lākou iho no COVID-19. Hiki i ka poʻe pono e hōʻoia i nā hopena ke hele i nā keʻena hoʻāʻo e kiʻi i nā hoʻokolohua qPCR hōʻoia hou.
ʻO ka Diagnosis and Treatment Protocol for COVID-19 (Trial Version 8), i hoʻokuʻu pū ʻia e ka National Health Commission a me ka National Administration of Traditional Chinese Medicine, e ʻōlelo maopopo ana ʻo ka hopena maikaʻi o ka hoʻāʻo ʻana i ka nucleic acid ka mea nui no ka maʻi COVID-19. Ke hoʻohālikelike ʻia i ka hoʻāʻo antigen wikiwiki, ʻoi aku ka maikaʻi o ka naʻau a me ka kikoʻī o ka hoʻāʻo ʻana o ka nucleic acid, a hiki ke ʻike i nā maʻi maʻi i kahi pae mua loa. Eia nō naʻe, ʻo ka hoʻāʻo ʻana o ka waika nucleic maʻamau e like me ka hoʻāʻo qPCR e koi i nā mea waiwai a me nā kaʻina hana paʻakikī, no laila e hoʻohana mua ʻia nā hoʻokolohua i nā haukapila, nā kikowaena hoʻāʻo ʻekolu a i ʻole nā laboratories. No laila, ʻaʻole kūpono ka hōʻike qPCR i ka loaʻa koke ʻana o nā hopena hōʻike ma nā kahua hoʻāʻo kaiaulu.
ʻOiai he maʻalahi a maʻalahi hoʻi ka hoʻāʻo antigen wikiwiki, ʻoi aku ka haʻahaʻa o kona naʻau ma mua o ka hoʻāʻo qPCR. I ka hapanui o nā hihia, hiki iā ia ke ʻike wale i nā laʻana maikaʻi ikaika, a inā ʻaʻole hiki i ka ʻike o nā maʻi i loko o nā laʻana i kahi helu, e loaʻa ana kahi probability of false negatives. No laila, i ka wā mua o ka maʻi, ʻoi aku ka pololei o ka hōʻike qPCR ma mua o ka hōʻike antigen.
Ua ʻōlelo ʻo Polofesa Zhou SONGYANG, ka mea nāna i hoʻokumu i ka Pluslife Biotech, "Me ka wikiwiki o ka hoʻolaha ʻana o COVID-19 a me ka hoʻonui ʻana i ka pono no ka nānā ʻana i ka COVID-19, e hoʻomohala ana i nā huahana nucleic acid Point of Care Testing (POCT) e like me ke kumu kūʻai haʻahaʻa a maʻalahi hoʻi. ʻO ka hoʻāʻo antigen wikiwiki, ʻoiai ka mālama ʻana i ka pololei a me ka naʻau e like me ka hoʻāʻo qPCR, he mea nui ia no ka hui holoʻokoʻa e hoʻomalu maikaʻi i ka maʻi maʻi.
ʻO Pluslife Biotech kahi mea hoʻomohala a hana i ka POCT nucleic acid testing & home-test products i hoʻokumu ʻia ma Greater Bay Area. Ua hoʻopuka koke ka ʻoihana i ka pūʻulu mua o nā kaukani hōʻike hōʻike no ka hoʻohana ʻana i nā haukapila a me nā keʻena ma Hong Kong. He ikaika hou ʻo Pluslife Biotech i ka hakakā ʻana i ka maʻi maʻi me ka ʻenehana, a ʻo kekahi o nā hui mua ma Kina e hoʻomaka i ka hoʻāʻo ʻana i ka waika nucleic acid POCT in vitro diagnostic (IVD). ʻO Pluslife Mini Dock, i hoʻomohala ʻia e Pluslife Biotech, ʻo ia ka huahana hoʻāʻo POCT nucleic acid mua no COVID-19. Ua hoʻopau ka hui i ka ʻōnaehana hoʻokele maikaʻi ISO13485 a me ka hōʻoia CE a loaʻa ke kūʻai aku ma nā wahi he nui a puni ka honua.
Hiki i ka ho'āʻo ʻana o ka waika nucleic POCT o Pluslife ke kiʻekiʻe kiʻekiʻe o ka naʻau, kikoʻī a me ka pololei, e like me ka hoʻāʻo qPCR. Hiki iā ia ke ʻike paʻa i nā maʻi maʻi ma kahi LoD haʻahaʻa loa (Limit of Detection). ʻO ka LoD paʻa maoli he 200 kope/mL, ʻoi aku ka maikaʻi ma mua o ka hoʻāʻo qPCR.
Eia kekahi, hoʻoponopono ʻo Pluslife Mini Dock i nā pilikia e pili ana i ka hilinaʻi ʻana i nā mea hana makamae (ua kūʻai pinepine ʻia ka ʻāpana hoʻokahi ma mua o nā haneli haneli o nā kālā Hong Kong), a hiki ke hoʻokō i ka hoʻāʻo ʻana o ka nucleic acid ma ka pae ʻāina a loaʻa nā hopena hōʻike. koke. Ma ke ʻano o ka hoʻāʻo ʻana, ma hope o ka lawe ʻana i ka laʻana o ka nasal swab mua, hoʻokomo nā mea hoʻohana i ka swab i loko o ka lysate a me ke kāleka hoʻāʻo, a laila hoʻokomo i ke kāleka hōʻike i loko o ka Mini Dock no ka hoʻāʻo ʻana i hoʻokahi ʻanuʻu a loaʻa nā hopena.
Ma ke ʻano o ka hoʻāʻo ʻana, hiki i ka Pluslife Mini Dock ke ʻike i kahi laʻana maikaʻi ma kahi o 15 mau minuke a hōʻoia i kahi laʻana maikaʻi ʻole i 35 mau minuke, e hōʻemi nui ana i ka manawa kali e hoʻohālikelike ʻia me ka hoʻāʻo qPCR (maʻa mau 3-4 mau hola me ka unuhi ʻana, ʻaʻole me ka hoʻoili ʻana o ka laʻana. manawa i ka lab). Ma ke ʻano o ke kumukūʻai, ʻoi aku ka maikaʻi o ke kumukūʻai o Pluslife Mini Dock ma mua o nā mea hana hoʻāʻo POCT nucleic acid i ka mākeke, a hiki ke hoʻohana hou ʻia, e kūpono ai no ka hoʻohana nui ʻana ma ka pae ʻāina.
Kākoʻo ʻia ka holomua o nā huahana koʻikoʻi, haʻahaʻa, maʻalahi e hoʻohana a hilinaʻi ʻia e kahi hui me nā mana hana hou a me ka manaʻo paʻa i ka ʻenehana.
Ua loaʻa iā Professor Zhou SONGYANG he mau makahiki o ka ʻike i ka noiʻi a me ka hoʻomohala ʻana ma ke kahua o ka ʻenekinia protein a me nā wahi ʻepekema ola ʻē aʻe. Ua paʻi ʻo ia ma mua o 150 mau ʻatikala ma ke ʻano he mea kākau mua a me ka mea kākau pili i loko o nā nūpepa kaulana kaulana e like me Cell, Nature and Science, me nā helu helu ʻoi aku ma mua o 19,000 mau manawa. Loaʻa i ka hui R&D ka hui mua o nā kālena kiʻekiʻe o nā ʻāina ʻē, nā polopeka, nā PhD a me nā loea kiʻekiʻe ma ka ʻoihana IVD, ka poʻe i loaʻa ka ʻike nui i nā protein kumu, nā ʻenehana assay, ka hoʻolālā huahana a me ka hana paʻa.
ʻO nā huahana qPCR kuʻuna e hilinaʻi nei i nā mahana kiʻekiʻe a loaʻa nā koi lako lako kiʻekiʻe, e hopena i ke kumukūʻai kiʻekiʻe o nā mea kani; ʻOiai ʻo ka hapa nui o ka isothermal nucleic acid hoʻāʻo e hiki ke hoʻoponopono i ka pilikia kumukūʻai a loaʻa ka wikiwiki amplification wikiwiki, akā ʻaʻole hiki iā lākou ke hoʻokō paʻa i ka naʻau maikaʻi a me ka kikoʻī, hiki ʻole iā lākou ke kuhikuhi pololei ʻia me qPCR, no laila no ka manawa lōʻihi ʻaʻohe ʻO ka hoʻāʻo ʻana o POCT nucleic acid i hana maikaʻi ʻia i hiki ke hoʻohana ʻia i nā ʻohana a me nā keʻena olakino olakino.
No ka hoʻomohala ʻana i kahi huahana hoʻāʻo wai nucleic POCT kiʻekiʻe, ua hoʻomohala ʻo Pluslife Biotech i ka RHAM, kahi ʻenehana i lalo me nā kuleana waiwai naʻauao kūʻokoʻa, ʻokoʻa ia mai nā ʻenehana hoʻonui isothermal maʻamau e like me ka ʻenehana ʻike LAMP a i ʻole CRISPR.
Hōʻike ka ʻenehana RHAM i ka hana like e like me qPCR, a ʻoi aku ka maikaʻi ma mua o nā ʻenehana isothermal amplification kuʻuna (e like me LAMP) ma ke ʻano o ka naʻau, kūpaʻa a me ka kikoʻī. ʻO ka hoʻomanawanui ākea a me ka ʻoi aku ka maikaʻi o ka RHAM e ʻike i ka hana hoʻokahi o ka hana hoʻohālike, hoʻonui a ʻike i nā mea āpau. ʻAʻole pili kēia kaʻina hana e like me ka wehe ʻana i ka poʻi ma hope o ka hoʻonui ʻana (ʻaʻohe aerosol contamination), a loaʻa nā koi haʻahaʻa no ke kaiapuni o waho a me ke kākoʻo lako. I kēia manawa, ua noi ʻo Pluslife Biotech no nā patent ma mua o 60 e pili ana i nā ʻenehana like ʻole me RHAM, ua hāʻawi ʻia ka nui o ia mau mea.
ʻO nā huahana hoʻāʻo COVID-19, i hōʻike ʻia e Pluslife Mini Dock, ua wehe i nā hiʻohiʻona hou aʻe no ka hoʻāʻo ʻana o POCT nucleic acid. Wahi a Polofesa Zhou SONGYANG, hiki ke hoʻohana ʻia ka Pluslife Mini Dock i nā hiʻohiʻona e like me nā kuʻuna, nā kahua hoʻāʻo mokulele, nā pilikia o ka haukapila, ka hoʻāʻo preoperative wikiwiki, mobile/field labs / hoʻāʻo me ka pūʻali koa, nā keʻena kaiāulu, a no ka hoʻāʻo ʻana i ka home. Ma o ka ho'āʻo maʻalahi ma ka pūnaewele, hiki ke hoʻokō ʻia ka pale ʻana i ka maʻi maʻi ma ke kumu. Hiki ke ʻike ʻia nā maʻi maʻi COVID-19 a hoʻopaʻa ʻia i ka wā mua, ʻoiai e hōʻemi ana i ka manawa kali no ka poʻe me nā hopena maikaʻi ʻole.
He aha e lawe ʻia mai kēia ʻatikala:
- Professor Zhou SONGYANG, Founder of Pluslife Biotech, said, “With the rapid spread of COVID-19 and increasing need for COVID-19 monitoring, developing suitable nucleic acid Point of Care Testing (POCT) products that are as low-cost and convenient as rapid antigen test, while retaining the accuracy and sensitivity the same as qPCR test, would be meaningful for the society as a whole to better control the pandemic.
- In terms of cost, the cost of Pluslife Mini Dock is much more affordable than other POCT nucleic acid testing instruments in the market, and it is also reusable, making it suitable for large-scale use at the grassroots level.
- In terms of testing efficiency, Pluslife Mini Dock can detect a positive sample in about 15 minutes and confirm a negative sample in 35 minutes, significantly reducing the waiting time compared to the qPCR test (usually 3-4 hours with extraction, not including sample transfer time to the lab).
