Virus Influenza A/Virus Influenza B
Jeneng produk
HWTS-RT176-Kit Deteksi Asam Nukleat Virus Influenza A/Virus Influenza B sing Dibeku-garing (PCR Fluoresensi)
Persetujuan Produk
IVDR
Epidemiologi
Miturut bedane antigenik antarane gen NP lan M, virus influenzabisa dipérang dadi patang jinis: virus influenza A (IFV A), virus influenza B (IFV B),virus influenza C (IFV C) lan virus influenza D (IFV D) [1]. Kanggo virus influenza A,nduweni akeh host lan serotipe kompleks lan bisa nyebar ing antarane host liwatrekombinasi genetik lan mutasi adaptif. Manungsa ora duwe kekebalan sing langgeng kanggovirus influenza A, mula wong-wong saka kabeh umur umume rentan. Virus influenza Aminangka patogen paling utama sing nyebabake pandemi influenza [2]. Kanggo virus influenza B,umume nyebar ing wilayah cilik lan saiki ora duwe subtipe. ManungsaInfeksi utamane disebabake dening virus influenza B/Yamagata utawa B/Victoriagaris keturunan. Antarane kasus influenza sing dikonfirmasi saben wulan ing 15 negaraIng wilayah Asia-Pasifik, tingkat diagnosis virus influenza B antara 0 nganti 92%[3]. Ora kaya virus influenza A, klompok wong tartamtu, kayata bocah-bocah lanwong tuwa, rentan kena virus influenza B, sing bisa nyebabake komplikasi,malah ndadekake beban luwih gedhe kanggo masyarakat tinimbang virus influenza A[4].Asil negatif ora ateges infeksi IFV A/B lan ora kena digunakake minangkasiji-sijine dhasar kanggo diagnosis, perawatan, utawa keputusan manajemen liyane. A positifAsil kasebut ora ngilangi infeksi bakteri utawa koinfeksi virus liyane ing njaba IFVVirus A/B.
Parameter Teknis
| Panyimpenan | 2-28℃ |
| Umur simpan | 12 sasi |
| Jinis Spesimen | swab orofaring manungsa, swab nasofaring |
| Ct | ≤38 |
| CV | <5.0% |
| LoD | 200 Salinan/mL utawa 0,05TCID50/mL |
| Spesifisitas | Reaktivitas silang: Ora ana reaktivitas silang antarane kit lan Bocavirus, Virus respiratory syncytial tipe B, Virus Herpes simplex tipe 1, Enterovirus, Adenovirus (Tipe 1), Adenovirus (Tipe 3), Adenovirus (Tipe 7), SARS-CoV, Adenovirus (Tipe 1), Adenovirus (Tipe 3), Adenovirus (Tipe 7), SARS-CoV, Norovirus, Streptococcus pneumoniae, Legionella, Bordetella pertussis, Neisseria gonorrhoeae, Aspergillus fumigatus, Moraxella catarrhalis, Rhinovirus, Virus parainfluenza (Tipe 1), Virus parainfluenza (Tipe 3), Virus parainfluenza (Tipe 2), Virus varicella-zoster, Virus campak, Virus corona manungsa, MERS-CoV, Chlamydia pneumoniae, Klebsiella pneumoniae, Pneumocystis jirovecii, Staphylococcus aureus, Candida albicans, Cryptococcus neoformans, Lactobacillus, Cytomegalovirus, virus Epstein-Barr, virus gondongan, human metapneumovirus (A1), human metapneumovirus (B2), novel coronavirus 2019-nCoV, Rotavirus, Mycoplasma pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Mycobacterium tuberculosis, Candida glabrata, Streptococcus salivarius, Corynebacterium, virus influenza A, virus influenza B, DNA genomik manungsa |
| Instrumen sing Ditrapake | Tipe I: Sistem PCR Wektu Nyata Biosistem Terapan 7500, SLAN-96PSistem PCR Wektu Nyata (Hongshi Medical Technology Co., Ltd.). Tes Tipe II: EudemonTM AIO800 (HWTS-EQ007) dening Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. |
Reagen/Instrumen dibutuhake nanging ora diwenehake
1) Kit Ekstraksi RNA: Kit DNA/RNA Viral Makro & Makro & Mikro-Tes(HWTS-3017) (sing bisa digunakake karo Makro & Mikro-Tes Otomatis NuklirEkstraktor Asam (HWTS-EQ011)) dening Jiangsu Macro & Micro-Test Med-Tech Co.,Ltd., Kit DNA/RNA Viral Tes Makro & Mikro (HWTS-3017-8) (digunakake karoEudemonTM AIO800 (HWTS-EQ007) dening Jiangsu Macro & Micro-Test Med-TechPerusahaan, Ltd.
2) Larutan Pengawetan Sampel: Kit Pengambilan Sampel Virus (JXZZ20182400236) deningYocon Biology (Beijing) Co., Ltd., UTM® Universal Transport Medium™(GXB20191277) dening Copan Italia SpA, Pangumpulan Sampel Makro & Mikro-Tes,Piranti Kirim & Pos (HWTS-3002) dening Jiangsu Macro & Micro-Test Med-TechPerusahaan, Ltd.
Barang konsumsi sing dibutuhake nanging ora diwenehake:Ujung bebas DNase/RNase, sarung tangan sekali pakai,Tabung EP bebas DNase/RNase.









