Monkeypox Virus rapid test kit 2022 MPV Nukléat Asam Deteksi Kit PCR Test kalawan CE Euro Sertifikasi

[PENDAHULUAN]
* Kit ieu dianggo pikeun deteksi kualitatif in vitro tina kasus anu disangka tina Monkeypox Virus (MPV), kasus clustered sareng kasus-kasus sanés anu * kedah didiagnosis inféksi Monkeypox Virus.
* Kit ieu dipaké pikeun ngadeteksi gén f3L tina MPV dina swab tikoro jeung sampel swab nasal.
*Hasil tés kit ieu ngan ukur pikeun rujukan klinis sareng henteu kedah dianggo salaku hiji-hijina kriteria pikeun diagnosis klinis. Disarankeun ngalaksanakeun analisa komprehensif ngeunaan kaayaan dumasar kana manifestasi klinis pasien sareng tés laboratorium anu sanés. 

[CIRI PRODUK]

[ Principle ]
Kit ieu nyokot runtuyan konservasi husus tina gén MPV f3L salaku wewengkon target. Téknologi PCR kuantitatif fluoresensi sacara real-time sareng téknologi pelepasan gancang asam nukléat dianggo pikeun ngawas asam nukléat virus ngaliwatan parobahan sinyal fluoresensi produk amplifikasi. Sistem deteksi kalebet kontrol kualitas internal, anu dianggo pikeun ngawas naha aya sambetan PCR dina conto atanapi naha sél dina conto dicandak, anu sacara efektif tiasa nyegah kaayaan négatip palsu.

[KOMPONEN UTAMA]

The kit contains reagents for processing 48 tests or quality control, including the following components:

Reagent A

Reag B

Catetan: Komponén tina angka bets béda teu bisa dipaké bulak balik

[Kaayaan Panyimpenan Sareng Kahirupan Rak] 
1.Reagent A/B can be stored at 2-30°C, and the shelf life is 10 months.
2.Please open the test tube cover only when you are ready for the test.
3. Ulah make tabung tés saluareun tanggal béakna.
4. Ulah make tube deteksi bocor.
[ Applicable Instrument ]
Cocog jeung Cocog jeung LC480 sistem analisis PCR, Gentier 48E Sistim analisis PCR otomatis, ABI7500 sistem analisis PCR.

[Syarat Sampel]
jenis sampel 1.Applicable: sampel swabs tikoro.
2. Solusi sampling: After verification, it is recommended to use normal saline or Virus preservation tube produced by Hangzhou Testsea biology for sample collection.
throat swab: usap amandel pharyngeal bilateral jeung tembok pharyngeal posterior kalawan swab sampling steril disposable, neuleumkeun swab kana tabung nu ngandung 3mL solusi sampling, piceun buntut, sarta tighten panutup tabung.
3.Sample gudang sarta pangiriman: The samples to be tested should be tested as soon as possible. The transportation temperature should be kept at 2~8ºC.The samples that can be tested within 24 hours can be stored at 2ºC~8ºC and if the samples cannot be tested within 24 hours, it should be stored at less than or equal to -70ºC (if there is no storage condition of -70ºC, it can be stored at -20ºC temporarily), avoid repeated
freezing and thawing.
4.Proper kempelan sampel, neundeun, sarta transportasi anu kritis kana kinerja produk ieu.
[Metode Tés]
1.Sample processing jeung tambahan sampel
1.1 conto ngolah
Saatos nyampur solusi sampling di luhur sareng conto, cokot 30μL sampel kana tabung réagen pelepasan DNA sareng aduk rata.
1.2 Ngamuat
Take 20μL of the reconstitution reagent and add it to the MPV detection reagent, add 5μL of the above processed sample (The positive control and negative control shall be processed in parallel with the samples), cover the tube cap, centrifuge it at 2000rpm for 10 seconds.
2. amplifikasi PCR
2.1 Muatkeun piring / tabung PCR anu disiapkeun kana alat PCR fluoresensi, Kontrol négatif sareng kontrol positif kedah diatur pikeun unggal tés.
2.2 Fluorescent channel setting:
1)Choose FAM channel for MPV detection;
2) Pilih saluran HEX / VIC pikeun deteksi gén kontrol internal;
3. Hasil analisis
Setel garis dasar di luhur titik pangluhurna kurva fluoresensi kontrol négatip.
4.Quality control
4.1 kontrol négatip: Taya nilai Ct kauninga dina FAM, HEX / channel VIC, atawa Ct> 40;
4.2 kontrol positif: Dina FAM,HEX/VIC channel, Ct≤40;
4.3 Sarat di luhur kedah dicumponan dina ékspérimén anu sami, upami henteu hasil tés henteu sah sareng ékspérimén kedah diulang deui.
[Nilai Dipotong]
Sampel dianggap positip nalika: Urutan target Ct≤40, Gén kontrol internal Ct≤40.
[ Interprétasi hasil ]
Sakali kadali kualitas diliwatan, pamaké kudu mariksa lamun aya kurva amplifikasi pikeun tiap sampel dina channel HEX / VIC, lamun aya tur kalawan Ct≤40, éta dituduhkeun gén kontrol internal ieu hasil amplified jeung test husus ieu valid. Pamaké bisa neruskeun kana analisis nurutan:
3. Pikeun sampel kalawan amplifikasi gén kontrol internal gagal (HEX/VIC
channel, Ct>40,or no amplification curve), low Viral load or the existence of PCR inhibitor could be the reason of failure, the examination should repeated from the specimen collection;
4. Pikeun sampel positif jeung virus berbudaya, hasil kontrol internal teu mangaruhan;
For samples tested negative, the internal control needs to be tested positive otherwise the overall result is invalid and the examination needs to be repeated, starting from the specimen collection step

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