Iqela B leStreptococcus Nucleic Acid
Igama lemveliso
Ikhithi yokuFumanisa i-HWTS-UR027-Group B Streptococcus Nucleic Acid (i-Fluorescence PCR)
I-HWTS-UR028-Ikhithi yokuFumanisa iStreptococcus Nucleic Acid eyomileyo kwiQela B (iFluorescence PCR)
Isatifikethi
CE, FDA
I-Epidemiology
I-Group B Streptococcus (GBS), eyaziwa ngokuba yi-streptococcus agalactiae, yintsholongwane enobungozi enegram-positive ehlala kwiindawo ezisezantsi zesisu kunye ne-urogenital zomzimba womntu. Malunga ne-10%-30% yabasetyhini abakhulelweyo bane-GBS vaginal survival.
Abafazi abakhulelweyo basesichengeni sosulelo lwe-GBS ngenxa yotshintsho olukwimeko yangaphakathi yendlela yokuzala ngenxa yotshintsho kumanqanaba ehomoni emzimbeni, nto leyo eya kubangela iziphumo ezimbi zokukhulelwa ezifana nokubeletha ngaphambi kwexesha, ukuqhekeka kwe-membranes ngaphambi kwexesha, kunye nokuzalwa komntwana oswelekileyo, kwaye kunokukhokelela kwiintsholongwane zokukhulelwa kwabasetyhini abakhulelweyo.
I-streptococcus yeqela leentsana ezisandul’ ukuzalwa inxulunyaniswa nosulelo oluvela ngaphambi kokuzalwa kwaye yintsholongwane ebalulekileyo yezifo ezisulelayo ezinzulu ezifana ne-sepsis yeentsana kunye ne-meningitis. Ama-40%-70% oomama abosulelwe yi-GBS baya kudlulisela i-GBS kwiintsana zabo ezisandul’ ukuzalwa ngexesha lokubeleka ngomjelo wokuzalwa, nto leyo ebangela izifo ezinzulu ezosulelayo zeentsana ezifana ne-sepsis yeentsana kunye ne-meningitis. Ukuba iintsana ezisandul’ ukuzalwa zine-GBS, malunga ne-1%-3% ziya kuba nosulelo olungena kwangethuba, apho ama-5% aya kuphumela ekufeni.
Itshaneli
| I-FAM | Ithagethi ye-GBS |
| I-VIC/HEX | Ulawulo lwangaphakathi |
Iiparameters zobugcisa
| Indawo yokugcina izinto | Ulwelo: ≤-18℃ ebumnyameni; I-Lyophilization: ≤30℃ ebumnyameni |
| Beka ubomi kwishelufa | Iinyanga ezili-12 |
| Uhlobo lweSibonelelo | Ukukhuhlana Kwesini Nesempundu |
| Ct | ≤38 |
| CV | ≤5.0％ |
| I-LoD | 1 × 103Iikopi/mL |
| Iintlobo ezingaphantsi ezigubungelayo | Fumana ii-serotypes ze-streptococcus zeqela B (I a, I b, I c, II, III, IV, V, VI, VII, VIII, IX kunye ne-ND) kwaye zonke iziphumo zilungile. |
| Ukuchaneka | Fumana ezinye iisampuli ze-genital tract kunye ne-rectal swab ezifana ne-candida albicans, i-trichomonas vaginalis, i-chlamydia trachomatis, i-ureaplasma urealyticum, i-neisseria gonorrhoeae, i-mycoplasma hominis, i-mycoplasma genitalium, i-herpes simplex virus, i-human papilloma virus, i-lactobacillus, i-gardnerella vaginalis, i-staphylococcus aureus, i-national negative reference N1-N10 (i-streptococcus pneumoniae, i-streptococcus pyogenes, i-streptococcus thermophilus, i-streptococcus mutans, i-streptococcus pyogenes, i-lactobacillus acidophilus bacillus, i-lactobacillus reuteri, i-escherichia coli DH5α, i-candida albicans) kunye ne-human genomic DNA, iziphumo zonke azikho kwi-group B streptococcus. |
| Izixhobo Ezisebenzayo | Ingalingana nezixhobo zePCR ezikhanyayo ezithengiswayo. Iinkqubo ze-PCR ze-SLAN-96P zeXesha langempela Iinkqubo ze-ABI 7500 ze-Real-Time PCR Iinkqubo ze-PCR zeQuantStudio®5 zeXesha langempela Iinkqubo ze-PCR zeLightCycler®480 zeXesha langempela Iinkqubo zokuFumanisa i-LineGene 9600 Plus zeXesha langempela ze-PCR I-MA-6000 Real-Time Quantitative Thermal Cycler |
Isisombululo se-PCR iyonke
