5-Ɔfã Mogya Ho Nhwehwɛmu Analyzer Control

5-Part Hematology Analyzer Control yɛ tri-level tri-phasic whole-mogya nkyerɛkyerɛmu ade a wɔayɛ sɛ wɔde bɛhwɛ sɛnea automated differential cell counters yɛ pɛpɛɛpɛ na ɛyɛ pɛpɛɛpɛ. Wɔde nnipa ne nnomaa nkwammoaa mu nneɛma a ɛyɛ den na ɛyɛe, na esuasua mogya a wɔayɛ no foforo wɔ mogya mu nkwammoaa fitaa, mogya mu nkwammoaa kɔkɔɔ, hemoglobin, ne mogya nkwammoaa mu nsonsonoe mu. Nneɛma a wɔyɛ no nyinaa de adwinnade pɔtee bi botae ahorow ka ho de hwɛ hu sɛ ɛne da biara da aduruyɛdan mu nneɛma a wɔhwɛ so yiye ho nhyehyɛe ahorow hyia.

Hematology controls ne calibrators yɛ nnwinnade a ɛho hia a wɔde hwɛ sɛnea nneɛma te wɔ ayaresabea aduruyɛdan ahorow mu, a ɛsono nea wɔde di dwuma wɔ adwumayɛ mu te sɛ diluents anaa lysing reagents.
Mogya Ho Nhwehwɛmu a Wɔde Di Dwuma:Nkwammoaa mu nsu a ɛyɛ den a wɔde ahyɛ mu a wɔadi kan -ahyɛ sɛ ɛyɛ den. Wɔsɔ wɔn hwɛ ka ayaresabea nhwɛsode ahorow a wɔyɛ no daa ho de hwɛ da biara da susuw pɛpɛɛpɛ, kyerɛ nhwehwɛmu a ɛkɔ akyiri, na wɔhwɛ sɛ mfitiase nhyehyɛe no yɛ adwuma yiye.
Hematology Calibrators: Nneɛma a Wɔde Yɛ Nneɛma:Nneɛma a wɔde gyina hɔ ma a ɛwɔ su kɛse a ɛwɔ nsɛntitiriw biako a wotumi hwehwɛ mu. Wɔde di dwuma nkutoo de siesie sɛnkyerɛnne kwan so mfaso nhyehyɛe na wɔde honam fam susuw mfitiasede sisi hɔ bere a wɔde nhyehyɛe no rehyɛ mu anaasɛ bere a wɔasiesie no kɛse akyi.

Nhwehwɛmu a wɔyɛ no daa a wɔde hwɛ sɛnea nneɛma te no hwɛ hu sɛ nhyehyɛe no gyina pintinn na nhwehwɛmu a ɛkɔ so pɛpɛɛpɛ wɔ da biara da aduruyɛdan mu dwumadi ahorow nyinaa mu:

Systemic Drift Nkyerɛkyerɛmu:Hu optical pathway misalignment, fluidic pressure fluctuations, ne reagent degradation ansa na ayarefo no aba.

Pɛpɛɛpɛ a Wɔde Di Dwuma:Tracks run-to-run na da-to{3}}da reproducibility wɔ standard deviation hye a wɔde asi hɔ mu.

Mmara kwan so Kyerɛwtohɔ a Wɔkora So:Ɔyɛ adwumayɛ ho kyerɛwtohɔ a wotumi hwehwɛ mu a ɛho hia ma aduruyɛdan mu adansedi akontaabu.

Nsonsonoe Gating Validation:Si optical scatter ne impedance gating algorithms so dua ma wohu leukocyte subpopulations pɛpɛɛpɛ.

Wɔde saa nsɛm a wɔde gyina so yi ma wɔ dodow abiɛsa a ɛsono emu biara mu de kyerɛ sɛ adwinnade no mmuae yɛ nokware wɔ ayaresabea susuw a edi mũ no nyinaa mu:
Level a Ɛba Fam
Simulates sub-nkwaboaa dodow a ɛyɛ daa. Ɔhwehwɛ susuw nkate ne linearity wɔ detection anohyeto a ɛba fam mu, hwɛ sɛ amanneɛbɔ a edi mu a ɛfa leukopenia, mogya a ɛtɔ kɔ mogya mu, ne thrombocytopenia ho.
Normal Level a Ɛyɛ Fɛ
Egyina hɔ ma nipadua mu nkwammoaa dodow a ɛte apɔw. Ɔsom sɛ da biara da gyinapɛn titiriw ma nhyehyɛe adwumayɛ a wɔyɛ no daa ne optical scatterplot nokwaredi.
Ɔsorosoroni a Ɛkorɔn
Ɔyɛ nkwammoaa mu dodow a ɛkɔ soro ho mfonini. Verifies susudua linearity a enni signal saturation anaa cell coincidence loss wɔ soro detection anohyeto.

Nsonsonoe a ɛda controls ne calibrators ntam no siw nsakrae a ɛmfata a wɔbɛyɛ wɔ factory calibration factors mu no ano na ɛkura sɔhwɛ no mudi mu kura mu:

Wɔhyehyɛɛ no ​​maa matrix nhyiamu wɔ automated 5-part differential platforms a wɔde semiconductor laser scatter, flow cytometry, nnuru staining, ne anyinam ahoɔden impedance mfiridwuma di dwuma. Parameter akwan a ɛne no hyia no bi ne:

• Anim hann apete, afã apete, ne fluorescence akwan
• Ɛlektrik impedance volume gating
• Colorimetric spectrophotometry a wɔde kyerɛ sɛnea hemoglobin dodow te

Wɔde reference measurement procedures na ɛsɔ lot biara hwɛ wɔ target analytical platforms so. Assay sheets ma target means ne ranges a wogye tom ma parameters 26 a edidi so yi:

Batch Pɛpɛɛpɛ:Wɔayɛ no wɔ ISO 13485 nhyehyɛe a ɛyɛ papa ase sɛnea ɛbɛyɛ a ɛbɛkɔ so akura nsakrae a ɛba fam koraa wɔ inter-lot (CV < 2.5%) mu.

Nhwehwɛmu a Wɔyɛ wɔ Wɔn a Wɔde Ma:Source biological materials nhwehwɛmu a ɛkyerɛ sɛ ɛnyɛ HBsAg, anti-HCV, ne anti-HIV antibodies denam standard screening assays so.

Homogeneity Nhwehwɛmu:Random sampling wɔ production runs nyinaa mu no yɛ akontabuo nhwehwɛmu ansa na wɔakyekyɛ.

Cold Chain a Wɔde Fa Nneɛma Kɔ:Nneɛma a wɔde fa po so hyɛn mu a wɔde nneɛma a ɛmma mframa nkɔ mu no ma emu hyew yɛ digrii 2 kosi digrii 8 bere a amanaman ntam akwantu no.

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