5-Part Hematology Analyzer Control em i wanpela tri-level tri-phasic ful-blut refrens materiel we ol i wokim bilong glasim stretpela na stretpela wok bilong ol otomatik diferensiel sel kaunta. Ol i wokim wantaim ol gutpela sel bilong man na pisin, na em i bihainim ol nupela blut bilong ol waitpela sel, retpela blut sel, hemoglobin, na ol pletlet. Olgeta wan wan prodaksen lot i gat ol instramen-spesifik mak veliu bilong mekim gut ol wok bilong kontrolim kwaliti bilong laboratori long olgeta de.
Wanem samting em ol 'hematology controls' / 'calibrators'?
Ol 'hematology control' na 'calibrator' i save wok olsem ol bikpela samting bilong lukautim gut ol samting insait long ol 'clinical laboratories', na i no wankain olsem ol samting bilong yusim olsem ol 'diluents' o 'lysing reagents'.
Ol samting bilong bosim blut:Ol stebol sel suspensen wantaim ol mak bilong konsentresen we ol i makim pinis. Ol i save testim ol wantaim ol klinik sempel bilong skelim stretpela bilong skelim ol samting long olgeta de, luksave long 'analytical drift', na sekim wok bilong 'baseline system'.
Hematology Calibrators:Ol 'reference materials' we i gat gutpela mak wantaim ol 'single traceable point values'. Ol i save yusim tasol long stretim ol seting bilong 'signal gain' na putim ol 'physical measurement baselines' taim ol i putim sistem o bihain long ol i mekim bikpela wok mentenens.
Rol long Hematology Kwaliti Kontrol
Ol wok painimaut bilong kwaliti kontrol i save mekim sistem i stap gut na i gat wankain wok painimaut long olgeta de long olgeta de wok bilong leboretri:
Sistemik Drift Identifikesen:Painim ol 'optical pathway misalignment', 'fluidic pressure' i senis, na 'reagent' i bagarap pastaim long ol i kisim ol risal bilong sikman.
Precision Verification:Ol trek i save ron-i go long-ran na de-i go long-de i ken kamap gen insait long ol standet deviesen baundri.
Regulatori Rekodkiping:I kamapim ol rekot bilong pefomens we ol i ken painim long en we ol i nidim long mekim ol odit bilong akreditesen bilong laboratori.
Diferensiel Gating Validesen:Em i strongim ol 'optical scatter' na 'impedance gating algorithms' bilong luksave stret long ol 'leukocyte subpopulations'.
Kontrol Level / Aplikesen
Dispela refrens materiel i stap long tripela kain konsentresen level bilong skelim bekim bilong instramen long olgeta klinikel mesamen ranj:
Low Level
I mekim wankain olsem ol sel konsentresen we i stap aninit long -normal. Skelim 'measurement sensitivity' na 'linearity' long ol liklik mak bilong painim, na sekim stretpela ripot bilong 'leukopenia', 'anemia', na 'thrombocytopenia'.
Nomal Level
I makim ol helti namba bilong ol sel bilong bodi. Em i stap olsem namba wan mak bilong skelim wok bilong ol sistem na verifikesen bilong 'optical scatterplot' long olgeta de.
Hai Level
I mekim wankain olsem ol sel konsentresen i go antap. Sekim 'measurement linearity' na i no gat 'signal saturation' o 'cell coincidence loss' long ol 'upper detection limits'.
Kontrol na Kalibreta
Pasin bilong luksave long ol kontrol na ol kalibreta i save stopim ol rong stretim long ol faktori kalibresen fakta na i save holim gut tes:
|
Wok bilong samting |
Hematology Kontrol |
Hematology Calibrator |
|
Namba wan wok |
Ol i wok long sekim stretpela na stebiliti |
Setim 'baseline accuracy' na 'gain adjustment' |
|
Testing Frekwensi |
Long olgeta de o long wanwan sif |
Bi-long wanwan yia o bihain long-mentenens |
|
Kain veliu ol i makim |
Taget min wantaim mak we i stap (±SD) |
Wanpela 'fixed refrens' veliu |
|
Sistem Impakt |
Monitim pefomens na i no senisim ol seting |
Em i save apdetim ol intanel kalibresen konstan stret |
Ol masin bilong skelim blut we i stret wantaim
Ol i wokim bilong mekim ol 'matrix' i ken wok gut wantaim ol 'automated 5-part differential platforms' we i yusim 'semiconductor laser scatter', 'flow cytometry', 'chemical staining', na ol 'electrical impedance' teknoloji. Ol 'parameter channels' we i ken wok wantaim em:
- Lait i go het, i go long sait, na ol 'fluorescence channels'
- Elektrikel impedens volium geting
- Kolorimetrik spektrofotometri bilong hemoglobin konsentresen
Ol veliu / parameta we ol i makim
Ol i save skelim olgeta wan wan lot long ol 'target analytical platforms' we ol i yusim ol 'reference measurement procedures'. Ol 'assay sheets' i givim ol 'target means' na ol 'acceptable ranges' bilong ol dispela 26 paramita:
|
Kategori |
Sotpela nem |
Nem bilong paramita |
Eksampel bilong mak bilong mak (Nomal) |
|
Namba bilong ol 'leukocyte' |
WBC |
Ol waitpela sel bilong blut |
6.5 - 8.5 × 10⁹/L |
|
Difrensel % |
NEU% / LYM% / MON% / EOS% / BAS% |
Ol 'Leukocyte Subpopulations' (%) |
Ol i kamapim long wanwan hap graun |
|
Differential Absolute |
NEU# / LYM# / MON# / EOS# / BAS# |
Leukocyte Subpopulations (Abs) |
Ol i kamapim long wanwan hap graun |
|
Namba bilong ol 'Erythrocyte' |
RBC |
Retpela Blut Sel |
4.00 - 5.00 × 10¹²/L |
|
Hemoglobin |
HGB |
Hemoglobin Konsentresen |
135 - 155 g/L |
|
Ol indeks |
HCT / MCV / MCH / MCHC |
Hematocrit & Red Cell Indices |
Standet mak bilong bodi |
|
Red Cell Width |
RDW-CV / RDW-SD |
Red Cell Distribution Width |
11.5 - 15.0 % |
|
Namba bilong ol pletlet |
PLT |
Namba bilong ol pletlet |
180 - 280 × 10⁹/L |
|
Ol Pletlet Indeks |
MPV / PDW / PCT |
Ol Pletlet Indeks |
Standet mak bilong bodi |
Ol spesifikasen bilong prodak
|
Teknikel Propati |
Spesifikasen |
|
Fom bilong bodi |
Suspensen wara; tudak ret taim yu miksim |
|
Matriks Sos |
Ol retpela sel bilong blut bilong man na ol samting bilong bodi i stap gut |
|
Kain botol |
Skruim-kap bilong ol botol wantaim 'puncture-permeable septa |
|
Ol opsen bilong volium |
2.0 mL / 3.0 mL / 4.0 mL |
|
Ol Konfigurasen bilong Pakejing |
Tri-level kombinesen set o singel-level bikpela paket |
|
Measurement Traceability |
Ol 'reference procedures' we ICSSH gaidens i makim |
Stoa na Stebiliti
|
Operesenel Paramita |
Gaidlain |
|
Tempereja bilong Stoa |
2 digri i go long 8 digri (35 digri F i go long 46 digri F). Noken mekim i kamap ais. Lukautim long lait. |
|
Laip bilong Shelf we i no op yet |
90 de stat long deit bilong wokim taim ol i putim long 2 digri -8 digri |
|
Open-Vial Stability |
14 de taim ol i kisim sempel bihainim protokol na putim hariap long aisbokis |
|
Themal Cycle Limit |
Inap long 14-pela 'thermal cycles' insait long 14-de open-vial windo |
Kwaliti Asurens
Batch Precision:Ol i wokim aninit long ISO 13485 kwaliti sistem bilong holim liklik senis namel long ol lot (CV < 2.5%).
Donor Screening:Ol samting bilong laip we ol i kisim i no gat HBsAg, anti-HCV, na anti-HIV antibodi long yusim ol standet skrining tes.
Homogeneity Analysis:Random sampling long olgeta prodaksen ran i save go insait long statistikel evaluesen pastaim long distribusen.
Cold Chain Shipping:Ol kontena bilong sip i gat insulesen i save holim tempereja insait long en namel long 2 digri na 8 digri long taim bilong intanesenel transit.
FAQ
Q: Olsem wanem ol i mas miksim botol pastaim long kisim sempel?
A: Rausim botol long aisbokis na larim em i stap long rum tempereja inap 15 minit. Rolim botol i go stret namel long ol han bilong yu 8 i go inap 10 taim, tanim isi isi 8 i go inap 10 taim, na sekim olsem 'cellular pellet' long daunbilo i pas gut gen. Noken mekim ol 'mechanical vortexing'.
Q: Wanem samting yu mas mekim sapos ol kontrol veliu i pundaun ausait long ol mak yu ting bai kamap?
A: Lukluk gut long 'vial' sapos i gat 'hemolysis', 'clotting', o 'microbial contamination'. Miksim gut gen dispela botol na mekim gen dispela wok painimaut. Sapos ol veliu i stap ausait long mak, sekim ol 'reagent fluidics', ol 'temperature controls', na ol 'background counts' pastaim long yu stretim ol seting bilong ol instramen.
Q: Dispela prodak inap long yusim long kalibretim wanpela 'analyzer'?
A: Nogat. Ol i wokim ol kontrol bilong sekim gut na sekim gut ol samting. Kalibresen i nidim ol dediket kalibreta materiel wantaim wanpela refrens setpoin.
Q: Olsem wanem taim rum tempereja i save mekim 'open-vial i stap gut?
A: Tempereja we i winim 25 digri i save mekim ol sel i bagarap hariap. Putim ol botol i go bek long 2 digri –8 digri stoa bihain stret long pulim wara bilong sempel.
Q: Ol 'target values' i stap long ol dijitel fomat?
A: Yes. Ol 'assay values', 'target means', na ol 'ranges' i stap long 'printed format' na olsem ol fail we yu ken daunlodim na i stret wantaim ol 'analyzer quality control software modules'.
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