The 5-Part Hematology Analyzer Control inhatu-level tri{{3}phasic whole-blood reference material yakagadziridzwa kuti itarise huchokwadi uye huchokwadi hweautomated differential cell counters. Yakagadzirwa neyakagadzika masero emunhu neavian, inoteedzera zvienzaniso zveropa zvitsva mukati memasero machena eropa, masero matsvuku eropa, hemoglobin, uye maplatelet. Yese yekugadzira mijenya inosanganisira chiridzwa-chaicho chinonangwa kukosha kuti ive nechokwadi chekuenderana zuva nezuva marabhoritari emhando yekudzora mapuroteni.
Chii chinonzi Hematology Controls / Calibrators?
Hematology inodzora uye macalibrator anoshanda seakakosha emhando yekutarisira maturusi mumakiriniki marabhoritari, akasiyana neanoshanda ekushandisa senge diluents kana lysing reagents.
Hematology Controls:Kumiswa kwemaserura kwakagadzikana ne-yakatemerwa maconcentration ranges. Ivo vanoyedzwa pamwe chete nemaitiro ekiriniki masampuli kuti vaongorore kuyerwa kwezuva nezuva, kuona analytical drift, uye kuona yekutanga system system.
Hematology Calibrators:Yakanyanya kucherechedzwa mareferensi zvinhu zvine imwechete inoteedzera point values. Iwo anoshandiswa chete kugadzirisa masaini ekuwana marongero uye kuseta ekutanga kuyerwa kwekutanga panguva yekuisa system kana mushure mekugadzirisa kukuru.
Basa muHematology Kudzora Hunhu
Routine quality control test inovimbisa kugadzikana kwesystem uye analytical kuenderana mukati memazuva ese mabasa erabhoritari:
Systemic Drift Identification:Inoona nzira yekusarongeka, fluidic pressure fluctuation, uye reagent degradation isati yabuda mhedzisiro yemurwere.
Precision Verification:Matuki anomhanya-ku{{1}kumhanya uye zuva-ku{3}kuberekana kwezuva mukati memiganhu yakatarwa.
Regulatory Recordkeeping:Inogadzira marekodhi ekuita anoteedzera anodiwa pakuongorora marabhoritari accreditation.
Differential Gating Validation:Inosimbisa Optical scatter uye impedance gating algorithms yechokwadi kuzivikanwa kweleukocyte subpopulations.
Kudzora Mazinga / Kushandisa
Ichi chinyorwa chinopihwa mumatanho matatu akasiyana ekusimbisa kuti asimbise mhinduro yezviridzwa mukati meiyo yakazara kiriniki kuyerwa renji:
Low Level
Inotevedzera-yakajairika maserura concentrations. Inotarisa kuyerwa kwekunzwa uye mutsara pamiganho yakaderera yekuona, kuratidza kurongeka kwakaringana kweleukopenia, anemia, uye thrombocytopenia.
Normal Level
Inomiririra hutano hwemasero ehutano. Inoshanda seyekutanga zuva nezuva bhenji rekuita maitiro system uye optical scatterplot verification.
High Level
Inotevedzera yakakwira cellular concentrations. Inosimbisa kuyerwa kwechiyero pasina kuzara kwechiratidzo kana kurasikirwa kwesero zvakasangana pazviyero zvekuonekwa.
Kudzora vs. Calibrator
Kusiyanisa pakati pezvinodzora uye calibrator zvinodzivirira zvigadziriso zvisina kunaka kune fekitori calibration zvinhu uye inochengetedza kutendeka kwebvunzo:
|
Functional Feature |
Hematology Control |
Hematology Calibrator |
|
Primary Function |
Kuenderera mberi nemazvo uye kugadzikana kwekutarisa |
Kugadzirisa kurongeka kwekutanga uye kuwana kugadzirisa |
|
Testing Frequency |
Zuva nezuva kana pashift |
Bi-pagore kana-kugadzirisa |
|
Yakagoverwa Kukosha Type |
Chinangwa chinoreva neyakatsanangurwa renji (± SD) |
Single fixed reference value |
|
System Impact |
Inotarisisa kuita pasina kushandura marongero |
Yakananga inogadziridza zvemukati calibration constants |
Inopindirana Hematology Analyzers
Yakagadzirirwa kuenderana kwematrix pane otomatiki 5-chikamu akasiyana mapuratifomu anoshandisa semiconductor laser scatter, kuyerera cytometry, makemikari kusvibisa, uye magetsi impedance tekinoroji. Inoenderana parameter nzira dzinosanganisira:
- Forward light scatter, side scatter, uye fluorescence channels
- Magetsi impedance vhoriyamu gating
- Colorimetric spectrophotometry ye hemoglobin concentration
Yakagoverwa Values / Parameters
Imwe neimwe mijenya inoyedzwa pane inonangwa yekuongorora mapuratifomu uchishandisa referensi kuyerwa maitiro. Mashizha eAssay anopa nzira dzakanangwa uye marenji anogamuchirwa eanotevera 26 paramita:
|
Category |
Kudimburira |
Parameter Zita |
Target Range Muenzaniso (Zvose) |
|
Leukocyte Count |
WBC |
Masero Machena Eropa |
6.5 - 8.5 × 10⁹/L |
|
Musiyano % |
NEU% / LYM% / MON% / EOS% / BAS% |
Leukocyte Subpopulations (%) |
Yakagadzirwa pane mujenya |
|
Differential Absolute |
NEU# / LYM# / MON# / EOS# / BAS# |
Leukocyte Subpopulations (Abs) |
Yakagadzirwa pane mujenya |
|
Erythrocyte Count |
RBC |
Masero Matsvuku eRopa |
4.00 - 5.00 × 10¹²/L |
|
Hemoglobin |
HGB |
Hemoglobin Concentration |
135 - 155 g/L |
|
indices |
HCT / MCV / MCH / MCHC |
Hematocrit uye Red Cell Indices |
Standard physiological bounds |
|
Red Cell Width |
RDW{{0}CV / RDW-SD |
Red Cell Distribution Width |
11.5 - 15.0 % |
|
Platelet Count |
PLT |
Platelet Count |
180 - 280 × 10⁹/L |
|
Platelet Indices |
MPV / PDW / PCT |
Platelet Indices |
Standard physiological bounds |
Zvigadzirwa Zvinotsanangurwa
|
Technical Property |
Tsanangudzo |
|
Chimiro Chemuviri |
Suspension liquid; tsvuku tsvuku kana yasanganiswa |
|
Matrix Source |
Yakagadzikana masero matsvuku eropa uye nucleated biological components |
|
Vial Type |
Dira{{0}zvivharo zvevhavha zvine puncture-permeable septa |
|
Volume Options |
2.0 mL / 3.0 mL / 4.0 mL |
|
Packaging Configurations |
Tri-level combination sets kana single{1}level yakawanda mapasuru |
|
Measurement Traceability |
Reference maitiro anotsanangurwa neICSSH nhungamiro |
Kuchengetedza & Kugadzikana
|
Operational Parameter |
Guideline |
|
Storage Temperature |
2℃kusvika 8℃(35℃F kusvika 46℃F). Usaomesa nechando. Dzivirira kubva kuchiedza. |
|
Hupenyu Husina Kuvhurwa |
Mazuva makumi mapfumbamwe kubva pazuva rekugadzira kana akachengetwa pa2℃-8 degree |
|
Vhura{{0}Vial Stability |
14 mazuva kana sampled zvinoenderana neprotocol uye nekukurumidza firiji |
|
Thermal Cycle Limit |
Kusvikira ku14 kutenderera kwemafuta mukati me14-yemazuva akavhurika hwindo |
Hunhu Hwakanaka
Batch Precision:Yakagadzirwa pasi peISO 13485 masisitimu emhando kuitira kuchengetedza mashoma epakati-yakawanda kusiyana (CV <2.5%).
Donor Screening:Kwakabva biological materials test negative zveHBsAg, anti-HCV, uye -masoja ekudzivirira eHIV achishandisa ongororo yakajairika.
Homogeneity Analysis:Random sampling mukati mekugadzira inomhanya inoongororwa nhamba isati yagoverwa.
Cold Chain Shipping:Insulated midziyo yekutakura inochengetedza tembiricha yemukati pakati pe2℃uye 8℃panguva yekufambisa kwenyika.
FAQ
Mubvunzo: Vial inofanira kusanganiswa sei isati yatorwa?
A: Bvisa vial kubva mufiriji yekuchengetedza uye uibvumira kuti igadzirise kutonhora kwekamuri kwemaminitsi gumi nemashanu. Rongedza vial yakatwasuka pakati pezvanza 8 kusvika gumi nguva, shandura zvinyoro 8 kusvika gumi nguva, uye simbisa iyo cellular pellet pazasi yakamiswa zvizere. Dzivisa mechanical vortexing.
Mubvunzo: Chii chinodiwa kana hutsika hwekutonga huchiwira kunze kwemiganhu inotarisirwa?
A: Ongorora vial nemaziso kuona hemolysis, clotting, kana microbial kusvibiswa. Dzokorora{{1}sanganisa bhodhoro zvakanaka uye dzokorora muyedzo. Kana ukoshi hukaramba huri kunze kwechikamu, tarisa reagent fluidics, tembiricha yekudzora, uye kumashure kuverenga usati wagadzirisa chiridzwa marongero.
Mubvunzo: Chigadzirwa ichi chinogona kushandiswa kugadzirisa analyzer?
A: Kwete. Zvidzoreso zvakagadzirirwa zvakanangana nekunyatsoongorora uye maitiro ekugadzirisa kugadzikana. Calibration inoda yakatsaurwa calibrator zvinhu zvine imwechete referensi seti.
Mubvunzo:
A: Tembiricha inopfuura 25 dhigirii inomhanyisa kuparara kweserura. Dzosa mabhodhoro ku2 dhigirii -8 dhigirii rekuchengetedza nekukurumidza mushure mekushuvira iyo inodiwa sampling vhoriyamu.
Mubvunzo: Ko kukosha kwakatarwa kunowanikwa mumafomati edhijitari?
A: Hongu. Assay values, chinangwa chenzira, uye marenji anopihwa akadhindwa fomati uye seanorodha mafaera anowirirana neanalyzer quality control software modules.
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