I-Innovative IVD Detection Reagents Revolutionize Arbovirus Diagnosis

Igciwane leZika, ilungu lomndeni wakwaFlaviviridae, lisakazeka kakhulu kubantu ngokulunywa umiyane osulelekile we-Aedes, njengo-Aedes aegypti no-Aedes albopictus. Leli gciwane labonakala okokuqala ngo-1947 eZika Forest e-Uganda, lapho lahlukaniswa khona nenkawu okuthiwa i-rhesus. Emashumini eminyaka, ukutheleleka ngegciwane leZika bekungavamile futhi kukhawulelwe ezimweni ezingavamile e-Afrika nase-Asia, nezifo eziningi ezibangela izimpawu ezithambile noma ezingenazo nhlobo. Kodwa-ke, ngo-2015, ukuqubuka okukhulu kwenzeka eBrazil, okwasakazekela ngokushesha kwamanye amazwe aseLatin America, eCaribbean, nangale kwayo, kwadonsa ukunaka komhlaba wonke.

Izimpawu zokutheleleka ngegciwane le-Zika ngokuvamile ziba mnene futhi zingabandakanya imfiva, ukuqubuka, ubuhlungu bamalunga, ubuhlungu bemisipha, ikhanda elibuhlungu kanye ne-conjunctivitis. Lezi zimpawu zivame ukuvela ezinsukwini ezi-2 kuya kweziyi-7 ngemuva kokulunywa umiyane onamagciwane futhi zihlala izinsuku ezimbili kuya kweziyi-7. Nakuba abantu abaningi belulama ngokugcwele ngaphandle kwezinkinga ezinzima, igciwane leZika liye laxhunyaniswa nokuphazamiseka okukhulu kwemizwa, ikakhulukazi i-microcephaly ezinganeni ezizalwa komama abangenwe yilesi sifo ngesikhathi sokukhulelwa, kanye nesifo sikaGuillain-Barré kubantu abadala.

Lapho sibhekene nosongo oluqhubekayo olubangelwa ama-arboviruses anjengeZika, Chikungunya, noDengue,Testsealabsyethule i-suite ye-advanced in vitro diagnostic (IVD) reagents, okumaka ukugxuma okubalulekile ekuxilongweni okunembile nokusheshayo kwalezi zifo. Lawa ma-reagents, okuhlanganisa i-Zika Virus Antibody IgG/IgM Test, i-ZIKA IgG/IgM/Chikungunya IgG/IgM Combo Test, kanye noDengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM Combo Test, kanye neDengue IgG/IgM yeDengue IgG/IgM ebanzi Ukuhlolwa kwe-IgG/IgM/Chikungunya, kusethelwe ukuguqula isimo sokuxilongwa kwe-arbovirus.

Inselele enkulu ekubhekaneni nalawa ma-arboviruses ukuthi izimpawu zabo zakuqala zifana kakhulu, ngokuvamile okuholela ekuxilongeni kabi. Ithebula elilandelayo ligqamisa izimpawu ezijwayelekile zeZika, uDengue, neChikungunya, kanye nemininingwane ebalulekile yomtholampilo, ekhombisa ukuthi kungani kuvela ukudideka:

*Kusekelwe ocwaningweni lwango-2024 lwezimo zomtholampilo ezingu-1,200 ezifundeni ezishisayo

**Kubandakanya ukuqoqwa kwesampula, ezokuthutha, nokuhlola okulandelanayo

Ngenxa yalokhu kufana okuphawulekayo kwezimpawu zokuqala kanye namazinga aphezulu okuxilonga (adlula ama-50% awo womathathu amagciwane), kunzima kakhulu kubahlinzeki bezokunakekelwa kwempilo ukuhlukanisa phakathi kwalezi zifo ngokusekelwe ekwethulweni komtholampilo kuphela. Isikhathi eside esidingekayo ukuze kuqinisekiswe ngokuhlolwa okukodwa kuqhubezela ukubambezeleka kokwelashwa nokulawula ukuqubuka. Yilapho kuqala khona ukuhlola kwethu kwe-combo. Ukwakhela phezu kwesisekelo sokuhlolwa kwekhadi elilodwa, sisungule ama-reagents okuthola inhlanganisela yamakhadi amaningi akwazi ukuhlonza izifo eziningi ekuhlolweni okukodwa, ukunciphisa isikhathi sokuxilongwa kufika ku-70% futhi sehlise izinga lokuxilonga libe ngaphansi kuka-5% ezivivinyweni zomtholampilo.

I-Zika Virus Antibody IgG/IgM Test: Ukuthola Ukutheleleka kweZika Ngokunemba

I-Zika Virus Antibody IgG/IgM Test iyi-chromatographic immunoassay esheshayo eyenzelwe ukutholwa kwekhwalithi yamasosha omzimba e-IgG ne-IgM kugciwane le-Zika egazini lomuntu lonke, i-serum, noma i-plasma. Lokhu kuhlolwa kusebenza njengosizo olubalulekile ekuxilongweni kwezifo ze-Zika virus. Ngokuthola ukuba khona kwalawa ma-antibody, abahlinzeki bezempilo banganquma ukuthi isiguli sisanda kuthola ukutheleleka (i-IgM positive) noma sike saba nokuchayeka okwedlule (i-IgG positive).

Izinzuzo Zomkhiqizo: Ukuhlola kugqama ngokuzwela kwakho okuphakeme kakhulu (98.6% ezivivinyweni zomtholampilo), okukwazi ukuthola amasosha omzimba ngisho nasezigabeni zokuqala zokutheleleka lapho amazinga e-antibody ephansi. Ukucaciswa kwayo okukhethekile (99.2%) kunciphisa ukusebenza kabusha okuphambene namasosha omzimba avela kuma-flavivirus ahlobene, okuqinisekisa imiphumela ethembekile. Ngaphezu kwalokho, ikhithi yokuhlola yakhelwe ukuzinza kwesikhathi eside, neshelufu yezinyanga ezingama-24 lapho igcinwe ku-2-8°C, inciphisa imfucuza futhi iqinisekise ukutholakala ezindaweni ezikude ezinengqalasizinda elinganiselwe yamaketanga abandayo.

I-ZIKA IgG/IgM/Chikungunya IgG/IgM Combo Test: Ukuxilongwa Okukabili Kwama-Arbovirus Ahlobene

I-ZIKA IgG/IgM/Chikungunya IgG/IgM Combo Test iyithuluzi elishintshashintshayo elivumela ukutholwa kanye nokuhlukaniswa ngesikhathi esisodwa kwamasosha omzimba e-immunoglobulin M (IgM) kanye ne-immunoglobulin G (IgG) kukho kokubili igciwane leZika kanye negciwane leChikungunya. I-Chikungunya, njenge-Zika, isifo esithwalwa omiyane esingabangela ubuhlungu obukhulu emalungeni, umkhuhlane, nokuqubuka.

Izinzuzo Zomkhiqizo: Lokhu kuhlolwa kwe-combo kuqeda isidingo sokuhlolwa okuhlukene kwe-Zika ne-Chikungunya, ukunciphisa isikhathi sokuhlola ngo-50% uma kuqhathaniswa nokuhlolwa ngakunye (kusuka esilinganisweni samahora angu-52 kuya kumaminithi angu-20). Isebenzisa uhlelo lokuhlonza lweziteshi ezimbili oluhlukile oluqinisekisa umehluko ocacile phakathi kwala magciwane amabili, ngezinga lokuphinda lisebenze elingaphansi kuka-1%, ligwema ukudideka okungavela ezimpawini ezifanayo zomtholampilo. Ukuhlola futhi kudinga umthamo wesampula omncane (u-5µL kuphela), okwenza kube ntofontofo ezigulini, ikakhulukazi izingane kanye nabantu abadala.

I-Dengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM Combo Test: Indlela Ephelele Yokuxilonga I-Arbovirus

I-Dengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM Combo Test iyisixazululo esibanzi esingatholi nje kuphela ubukhona begciwane lodenga ngokutholwa kwe-NS1 antigen, IgG, ne-IgM kodwa futhi ihlola amasosha omzimba eZika virus IgG ne-IgM. Udenga luyinkinga enkulu yezempilo yomphakathi ezindaweni eziningi ezishisayo nezishisayo, okubangela inhlobonhlobo yezimpawu kusukela ekuguleni okunjengomkhuhlane kuya kumkhuhlane wodenga oyingozi kakhulu futhi ongase ube yingozi empilweni.

Izinzuzo Zomkhiqizo: Ukufakwa kokutholwa kwe-antigen ye-NS1 kunika amandla ukuxilongwa kusenesikhathi koDengue ezinsukwini ezi-1-2 ngemuva kokuqala kwezimpawu, nokuzwela okungama-97.3% kokutholwa kwe-NS1, okubalulekile ekwelashweni okufika ngesikhathi ukuze kuvinjelwe izinkinga ezinzima (ezivela ku-10-20% wezigameko ezingalashwa). Ukutholwa kokuhlolwa okunamapharamitha amaningi (NS1, IgG, IgM for Dengue and IgG, IgM for Zika) kunikeza iphrofayili yokuxilonga ebanzi, ukusiza abahlinzeki bezempilo baqonde isigaba sokutheleleka futhi benze izinqumo zokwelashwa ezinolwazi. Ukwengeza, ukuhlolwa kuqinisekisiwe ukuthi kusetshenziswe ezilungiselelweni ezihlukahlukene zomtholampilo, okubonisa ukusebenza okungaguquki kuwo wonke amalabhorethri ahlukene ane-coefficient of variation (CV) engaphansi kuka-5%.

I-Dengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM/Chikungunya Test: The Ultimate Arbovirus Diagnostic Tool

Ukuhlolwa kweDengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM/Chikungunya kubeka ezingeni elilandelayo ngokuhlanganisa amandla okubona kukho konke ukuhlola kwangaphambilini nokungeza ukutholwa kwamasosha omzimba eChikungunya virus IgG kanye ne-IgM. Lokhu kuhlola konke-kokukodwa kuklanyelwe ukuhlinzeka ngokuxilongwa okuphelele nokunembile kwezifo eziningi ze-arbovirus ekuhlolweni okukodwa.

Izinzuzo Zomkhiqizo: Lokhu kuhlola okuhlanganisa konke kunikeza ukusebenza kahle okungenakuqhathaniswa ngokuthola ama-arbovirus amakhulu amathathu ngesikhathi esisodwa, ukwehlisa izindleko eziphelele ngesiguli ngasinye ngama-40% uma kuqhathaniswa nokuhlolwa komuntu ngamunye futhi kunciphisa kakhulu umthwalo wezisebenzi zaselabhorethri. Ifaka ubuchwepheshe obuthuthukisiwe bokukhulisa isignali obuthuthukisa ukuzwela kokutholwa kwakho konke okuqondiwe (isilinganiso sokuzwela esingu-98.1% kuzo zonke izihlaziyi), iqinisekisa ukuthi ngisho nezifo ezisezingeni eliphansi azigeji. Ukuhlola futhi kuza nesixhumi esibonakalayo esisebenziseka kalula kanye nemihlahlandlela ecacile yokutolika imiphumela, okwenza kube lula ukusebenzisa ngisho nakubasebenzi bezempilo abanolwazi oluncane, ngesikhathi sokuqeqeshwa samahora angu-2 kuphela adingekayo ukuze uthole ulwazi.

Izici Nezinzuzo zeTestsealabs I-IVD Detection Reagents

• Imiphumela Esheshayo: Konke lokhu kuhlola kunikeza imiphumela ngesikhathi esifushane, ngokuvamile phakathi nemizuzu engu-15, okuvumela ukuthathwa kwezinqumo ngokushesha ekuxilongweni nasekulapheni iziguli.
• Ukuzwela Okuphezulu kanye Nokucaciswa: Ukuhlola kuklanyelwe ukuzwela kakhulu (≥97%), okuqinisekisa ukutholwa kwamazinga aphansi amasosha omzimba noma ama-antigen, kanye nokucaciswa (≥99%), okunciphisa ubungozi bezinto ezingamanga. Lokhu kubalulekile ekuxilongweni okunembile nokuphathwa kwesiguli ngendlela efanele.
• Izinhlobo Zesampula Eziguqukayo: Angasetshenziswa nezinhlobonhlobo zezinhlobo zesampula, okuhlanganisa igazi eliphelele leminwe, igazi eligcwele le-venous, i-serum, ne-plasma, okuyenza ifanelekele ukusetshenziswa kuzilungiselelo ezihlukene zomtholampilo nezindawo zokunakekela.
• Ukusebenziseka kalula: Ukuhlola kulula ukukwenza futhi kudinga ukuqeqeshwa okuncane, okubenza bafinyeleleke kubahlinzeki bokunakekelwa kwezempilo kuzo zombili izindawo ezinothile nezinsizakusebenza ezinomkhawulo.
• Imiphumela Yezinjongo: Izivivinyo eziningi, njengalezo ezisebenzisa ubuchwepheshe be-DPP (I-Dual Path Platform) enelungelo lobunikazi, zinikeza imiphumela eqondile kusetshenziswa isifundi esilula esiphathwa ngesandla sedijithali, okunciphisa amandla okuba nephutha lomuntu ekuchazeni umphumela.

Isiphetho

Testsealabsuhla olusha lwama-reagents okuthola i-IVD lwe-Zika, Chikungunya, kanye namagciwane oDengue lumelela intuthuko enkulu emkhakheni wokuxilongwa kwe-arbovirus. Uma kubhekwa ukufana okuphezulu kwezimpawu zakuqala kanye namazinga aphezulu ngendlela eshaqisayo okuxilongwa okungalungile (ngaphezu kwama-50%) phakathi kwalezi zifo, ukuhlolwa kwethu kwe-combo, okuthuthukiswe ekuhlolweni kwekhadi elilodwa, okungathola izifo eziningi ngesikhathi esisodwa ngamazinga okuxilongwa okungalungile angaphansi kuka-5% kanye nezikhathi zokuxilongwa ngaphansi kwemizuzu engu-20, zibaluleke kakhulu. Ngezinzuzo zabo eziyingqayizivele zomkhiqizo ohlanganisa ukuzwela okuphezulu, ukucaciswa, ukusebenza kahle, kanye nokusebenziseka kalula, lawa ma-reagents asethwe ukuze achaze kabusha ukuthi izifo ze-arbovirus zitholwa futhi ziphathwe kanjani. Ngokuhlinzeka abahlinzeki bezempilo ngamathuluzi okuxilonga anembile, asheshayo, futhi aphelele, lawa ma-reagents anamandla okuthuthukisa imiphumela yesiguli, athuthukise ukubhekwa kwezifo, futhi abambe iqhaza ekulawuleni ngempumelelo ukuqubuka kwe-arbovirus. Njengoba umthwalo womhlaba wonke wezifo ze-arbovirus uqhubeka nokukhula, lezi zivivinyo ezintsha zisethelwe ukudlala indima ebalulekile ekulweni nalezi zinsongo ezibalulekile zezempilo yomphakathi.