IiReagents zokuFumana ezintsha ze-IVD ziguqule uFundo lweArbovirus

Intsholongwane kaZika, ilungu lentsapho yeFlaviviridae, isasazeka ebantwini ngokulunywa yingcongconi ye-Aedes, efana ne-Aedes aegypti kunye ne-Aedes albopictus. Le ntsholongwane yaqala ukuchongwa ngo-1947 kwiHlathi laseZika laseUganda, apho yahlala yodwa kwinkawu yerhesus. Kwiminyaka emininzi, usulelo lwe-Zika lwentsholongwane lwalunqabile kwaye lukhawulelwe kwiimeko eziqhelekileyo e-Afrika nase-Asia, kunye nosulelo oluninzi olubangela iimpawu ezincinci okanye ezingenazo. Nangona kunjalo, kwi-2015, ukuqhambuka okukhulu kwenzeke eBrazil, okwasasazeka ngokukhawuleza kwamanye amazwe eLatin America, iCaribbean, nangaphaya, ukutsala ingqalelo yehlabathi.

Iimpawu zokosuleleka yintsholongwane kaZika zihlala zincinci kwaye zinokubandakanya umkhuhlane, irhashalala, iintlungu zamalungu, iintlungu zemisipha, intloko ebuhlungu, kunye ne-conjunctivitis. Ezi mpawu zikholisa ukuvela kwiintsuku ezi-2 ukuya kwezi-7 emva kokulunywa yingcongconi eyosulelekileyo kwaye zihlala iintsuku ezi-2 ukuya kwezi-7. Ngelixa abaninzi abantu bephila ngokupheleleyo ngaphandle kweengxaki ezinzima, i-virus yeZika iye yadibaniswa neengxaki ezinzulu ze-neurological, ngokukodwa i-microcephaly kwiintsana ezizalwa ngoomama abasulelekileyo ngexesha lokukhulelwa, kunye ne-Guillain-Barré syndrome kubantu abadala.

Ebusweni besoyikiso esiqhubekayo esibangelwa yi-arboviruses efana neZika, Chikungunya, kunye neDengue,Testselabsiye yazisa i-suite ye-advanced in vitro diagnostic (IVD) reagents, ephawula ukutsiba okubalulekileyo ekuxilongeni ngokuchanekileyo nangokukhawuleza kwezi zifo. Ezi reagents, kuquka i-Zika Virus Antibody IgG/IgM Test, i-ZIKA IgG/IgM/Chikungunya IgG/IgM Combo Test, kunye neDengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM Combo Test, kunye neDengue Dengue NS1/Dengue IgG/I-Dengue ebanzi Uvavanyo lwe-IgG/IgM/Chikungunya, lusetelwe ukuguqula indawo yokuxilongwa kwe-arbovirus.

Umceli mngeni omkhulu ekujonganeni nezi arboviruses kukuba iimpawu zabo zokuqala zifana kakhulu, zihlala zikhokelela ekuxilongeni kakubi. Le theyibhile ilandelayo igxininisa iimpawu eziqhelekileyo zeZika, iDengue, kunye neChikungunya, kunye nedatha ephambili yekliniki, ebonisa ukuba kutheni kuvela ukudideka:

*Ngokusekwe kuphononongo luka-2024 lweemeko zeklinikhi ezili-1,200 kwimimandla etshisayo

**Kubandakanya ukuqokelela iisampulu, ukuthuthwa, kunye novavanyo olulandelelanayo

Ngenxa yoku kufana okumangalisayo kweempawu zokuqala kunye namazinga aphezulu oxilongo (angaphezulu kwama-50% kuzo zontathu iintsholongwane), kunzima kakhulu kubaboneleli bezempilo ukuba bahlule phakathi kwezi zifo ngokusekelwe kwinkcazo yezonyango kuphela. Ixesha elide elifunekayo ukuze kuqinisekiswe ngovavanyo olulodwa lulibazisa ngakumbi unyango kunye nolawulo lokuqhambuka. Apha kulapho uvavanyo lwethu lwe-combo luqala khona ukudlala. Ukwakha kwisiseko sovavanyo lwekhadi elinye, siye saqulunqa ii-reagents zokufumanisa ukudibanisa kwamakhadi amaninzi anokuchonga izifo ezininzi kuvavanyo olunye, ukucutha ixesha lokuxilongwa ukuya kuthi ga kwi-70% kunye nokunciphisa amazinga okuxilongwa kakubi ukuya ngaphantsi kwe-5% kwizilingo zeklinikhi.

Uvavanyo lweZika Virus Antibody IgG/IgM: Ukufumanisa iZika usulelo ngokuchaneka

Uvavanyo lweZika Virus Antibody IgG/IgM luvavanyo olukhawulezayo lwe-chromatographic immunoassay eyenzelwe ukuchongwa okusemgangathweni kwe-IgG kunye ne-IgM ye-antibodies kwintsholongwane yeZika egazini lomntu wonke, i-serum, okanye iplasma. Olu vavanyo lusebenza njengoncedo olubalulekileyo ekufunyanisweni kosulelo lwentsholongwane kaZika. Ngokubona ubukho bezi zithinteli-gazi, ababoneleli bezempilo banokugqiba ukuba ngaba isigulane sisandul 'ukusuleleka (i-IgM positive) okanye siye safumana ixesha elidlulileyo (IgG positive).

Iinzuzo zeMveliso: Uvavanyo lugqame ngobuntununtunu be-ultra-high (98.6% kulingo lwezonyango), olukwaziyo ukufumanisa izilwa-buhlungu nakwizigaba zokuqala zosulelo xa amanqanaba e-antibody esezantsi. Ukuchaneka kwayo okukhethekileyo (99.2%) kunciphisa i-cross-reactivity kunye ne-antibodies ezivela kwii-flaviviruses ezinxulumene, ukuqinisekisa iziphumo ezithembekileyo. Ngaphezu koko, ikiti yokuvavanya yenzelwe ukuzinza kwexesha elide, kunye neshelufu yeenyanga ezingama-24 xa igcinwe kwi-2-8 ° C, ukunciphisa inkunkuma kunye nokuqinisekisa ukufumaneka kwiindawo ezikude ezineziseko ezinqabileyo ezibandayo.

I-ZIKA IgG/IgM/Chikungunya IgG/IgM Combo Test: Ukuxilongwa kabini kwiiArboviruses eziNxulumeneyo

Uvavanyo lwe-ZIKA IgG/IgM/Chikungunya IgG/IgM Combo sisixhobo soguqulo esivumela ukufunyanwa ngaxeshanye kunye nokwahlulahlula kwe-immunoglobulin M (IgM) kunye ne-immunoglobulin G (IgG) kwi-antibodies kwi-virus ye-Zika kunye ne-Chikungunya virus. I-Chikungunya, njengeZika, isifo esithwalwa yingcongconi esinokubangela intlungu edibeneyo, umkhuhlane kunye nokugqithisa.

Iinzuzo zeMveliso: Olu vavanyo lwe-combo luphelisa imfuno yovavanyo oluhlukeneyo lweZika kunye neChikungunya, ukunciphisa ixesha lokuvavanya nge-50% xa kuthelekiswa novavanyo lomntu ngamnye (ukusuka kumyinge weeyure ezingama-52 ukuya kwimizuzu engama-20). Isebenzisa inkqubo yokufumanisa imijelo emibini ekhethekileyo eqinisekisa umahluko ocacileyo phakathi kweentsholongwane ezimbini, kunye nesantya sokuphinda sisebenze kwakhona esingaphantsi kwe-1%, ukuthintela ukubhideka okunokuthi kuvele kwiimpawu zeklinikhi ezifanayo. Uvavanyo lukwafuna umthamo omncinci wesampulu (kuphela i-5µL), iyenza ikhululeke ngakumbi kwizigulane, ngakumbi abantwana kunye nabantu abadala.

Uvavanyo lweDengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM Combo Test: Indlela eNgqongileyo yokuHlola iArbovirus

Uvavanyo lweDengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM Combo sisisombululo esibanzi esingafumani nje ubukho bentsholongwane yeDengue ngokubhaqwa kwe-NS1 antigen, IgG, kunye ne-IgM antibodies kodwa kwakhona izikrini zeZika virus IgG kunye ne-IgM antibodies. I-Dengue yeyona nto iphambili kwimpilo yoluntu kwimimandla emininzi etshisayo kunye ne-subtropical, ebangela uluhlu olubanzi lweempawu ukusuka kwisigulo esifana nomkhuhlane ukuya kumandundu kwaye anokubeka ubomi esichengeni i-dengue hemorrhagic fever.

Iinzuzo zeMveliso: Ukufakwa kwe-NS1 ukufumanisa i-antigen kuvumela ukuxilongwa kwangaphambili kwe-Dengue kwangoko ngeentsuku ze-1-2 emva kokuqala kweempawu, kunye novakalelo lwe-97.3% yokufumanisa i-NS1, eyona nto ibalulekileyo kunyango lwangexesha ukukhusela iingxaki ezinzima (eziphuhliswa kwi-10-20% yamatyala angaphendulwanga). Uvavanyo lwe-parameter ye-multi-parameter (NS1, IgG, IgM yeDengue kunye ne-IgG, i-IgM ye-Zika) inikeza iphrofayili ebanzi yokuxilonga, ukunceda ababoneleli bezempilo baqonde isigaba sokusuleleka kunye nokwenza izigqibo zonyango ezinolwazi. Ukongezelela, uvavanyo luye lwaqinisekiswa ukuba lusetyenziswe kwimimiselo eyahlukeneyo yeklinikhi, ebonisa ukusebenza okuhambelanayo kwiilebhu ezahlukeneyo kunye ne-coefficient of variation (CV) engaphantsi kwe-5%.

I-Dengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM/Chikungunya Test: Esona sixhobo Sokuxilonga seArbovirus

Uvavanyo lweDengue NS1/Dengue IgG/IgM/Zika Virus IgG/IgM/Chikungunya luthatha ukuxilongwa kwe-arbovirus ukuya kwinqanaba elilandelayo ngokudibanisa amandla okubona zonke iimvavanyo zangaphambili kunye nokongeza ukufunyanwa kwe-Chikungunya virus IgG kunye ne-IgM antibodies. Olu vavanyo lwe-in-one lwenzelwe ukubonelela ngoxilongo olubanzi noluchanekileyo lwezifo ezininzi ze-arbovirus kwi-assay enye.

Iinzuzo zeMveliso: Olu vavanyo olubandakanya konke lunikeza ukusebenza kakuhle okungenakulinganiswa ngokufumanisa i-arboviruses ezintathu ezinkulu ngexesha elinye, ukunciphisa iindleko ezipheleleyo ngesigulane nge-40% xa kuthelekiswa novavanyo lomntu ngamnye kunye nokunciphisa kakhulu umsebenzi wabasebenzi basebhubhoratri. Ibonisa iteknoloji yokukhulisa umqondiso ophuculweyo ophucula ubuntununtunu bokubona kuzo zonke iithagethi (umyinge wobuntununtunu be-98.1% kubo bonke abahlalutyi), iqinisekisa ukuba nosulelo olukwinqanaba elisezantsi aluphoswa. Uvavanyo kwakhona luza kunye nomsebenzisi-friendly interface kunye nezikhokelo zokutolika iziphumo ezicacileyo, okwenza kube lula ukusebenzisa nabasebenzi bezempilo abanamava, kunye nexesha loqeqesho lweeyure ezi-2 kuphela ezifunekayo kubuchule.

Iimpawu kunye neeNzuzo zeTestselabs IiReagents zokufumanisa i-IVD

• Iziphumo eziKhawulezayo: Zonke ezi mvavanyo zibonelela ngeziphumo ngexesha elifutshane, ngokuqhelekileyo ngaphakathi kwemizuzu eyi-15, evumela ukuthathwa kwezigqibo ngokukhawuleza ekuxilongweni kunye nonyango lwezigulane.
• Uvakalelo oluPhezulu kunye nokuNgcaciswa: Iimvavanyo zenzelwe ukuba zibe novakalelo oluphezulu (≥97%), ukuqinisekisa ukufunyanwa kwamanqanaba aphantsi e-antibodies okanye i-antigens, kunye neyodwa (≥99%), ukunciphisa umngcipheko wobuxoki. Oku kubalulekile kuxilongo oluchanekileyo kunye nolawulo olululo lwezigulane.
• Iintlobo zeesampuli eziguquguqukayo: Zingasetyenziswa kunye neentlobo zeesampulu ezahlukeneyo, kubandakanywa igazi elipheleleyo leminwe, igazi elipheleleyo le-venous, i-serum, kunye ne-plasma, ezenza zilungele ukusetyenziswa kwiikliniki ezahlukeneyo kunye neendawo zokunyamekela.
• Ukusebenziseka lula: Iimvavanyo zilula ukuzenza kwaye zifuna uqeqesho oluncinci, okwenza ukuba zifikeleleke kubaboneleli bezempilo kuzo zombini iindawo ezinobutyebi kunye nezixhobo ezilinganiselweyo.
• Iziphumo zeNjongo: Uninzi lweemvavanyo, njengalezo zisebenzisa iteknoloji ye-DPP enelungelo lobunikazi (i-Dual Path Platform) iteknoloji, ibonelela ngeziphumo ezinenjongo usebenzisa i-handheld reader yedijithali, ukunciphisa amandla okuba nephutha lomntu kwisiphumo sokutolika.

Ukuqukumbela

Testselabsuluhlu olutsha lwee-reagents ze-IVD zokufumanisa i-Zika, i-Chikungunya, kunye ne-Dengue virus imele ukuqhubela phambili okubonakalayo kwintsimi yokuxilongwa kwe-arbovirus. Ukunika ukufana okuphezulu kweempawu zokuqala kunye namazinga aphezulu ngokumangalisayo okuxilonga (ngaphezulu kwe-50%) phakathi kwezi zifo, iimvavanyo zethu ze-combo, eziphuhliswe kwiimvavanyo zekhadi elinye, ezinokufumanisa izifo ezininzi ngaxeshanye kunye namazinga okuxilongwa kakubi ngaphantsi kwe-5% kunye namaxesha okuxilongwa phantsi kwemizuzu engama-20, kubaluleke kakhulu. Ngeenzuzo zabo zemveliso ezizodwa ezibandakanya uvakalelo oluphezulu, ukuchaneka, ukusebenza kakuhle, kunye nokulula kokusetyenziswa, ezi zixhobo zisetyenziselwe ukucacisa kwakhona ukuba izifo ze-arbovirus zifunyaniswa kwaye zilawulwa njani. Ngokubonelela ababoneleli bezempilo ngezixhobo zokuxilonga ezichanekileyo, ezikhawulezayo, kunye nezibanzi, ezi zixhobo zinamandla okuphucula iziphumo zesigulane, ukuphucula ukubhekwa kwezifo, kunye negalelo ekulawuleni okusebenzayo kokuqhambuka kwe-arbovirus. Njengoko umthwalo wehlabathi jikelele wezifo ze-arbovirus uqhubeka ukhula, ezi mvavanyo zintsha zibekwe ukuba zidlale indima ebalulekileyo ekulweni nezi zoyikiso ezibalulekileyo zempilo yoluntu.