Reticulocyte Hematology Control hian tri-level quality management material a pe a, chu chu reticulocyte parameters titu automated hematology analyzer te dikna leh dikna enfiah nan a bik taka siam a ni.
Hematology Control / Calibrator te hi eng nge ni?
Hematology control leh calibrator te hi laboratory analytical verification atana biological reference material mamawh a ni.
Controls tenitin hnathawh danah system performance endikna atan, analytical drift enfiahna atan, leh continuous precision verify turin designated target ranges nei stabilized whole-blood preparations an ni.
Calibrators te pawh a awmhi high-precision standards an ni a, reference value pek an ni a, hematology instrument-a mathematical response curve set emaw siamrem emaw nan a hun hunah hman thin an ni.
Hematology Quality Control-a a chanvo
Reticulocyte parameters hian erythrocyte puitling lote structural leh RNA staining characteristic danglam tak avang hian dedicated control materials a mamawh a ni.
Routine Precision Tracking neih dan tur: 1.1.Damlo sample test hmain analytical variation leh optical performance shift te a hmuchhuak thin.
Statistical Process Control dan tur: 1.1.Operational shift hrang hranga Levey-Jennings charting leh multi-rule quality control evaluation te a thlawp a ni.
System zawm dan: 1.1.International laboratory accreditation standard hrang hrangte tana baseline analytical verification data a pe chhuak thin.
Control Level / A hman dan tur
Level 1 (Hnuai zawk): .Detection limit hniam zawk hnaihah measurement sensitivity verify turin reticulocyte concentration hniam tak a nei a, hei hian bone marrow suppression evaluation te a thlawp a ni.
Level 2 (A tlangpuiin): 1.1.Routine clinical screening tihdik nan physiological reference range te a mirror thin.
Level 3 (High): 1.1.Upper measurement range hrang hranga analytical linearity nemnghet turin reticulocyte concentration sang tak a thleng.
Control leh Calibrator te a ni
|
Mihring ziarang |
Thunun |
Calibrator a ni |
|
Hnathawh hmasa ber |
Routine precision tracking a awm thin |
Parameter scaling leh alignment te a awm bawk |
|
Testing neih tam dan |
Nitin emaw, operating shift khatah emaw |
A hun hunah emaw, enkawl zawh hnuah emaw |
|
Assigned Value a ni |
Target range (A awmzia $\\pm 2\\text{SD}$) a ni. |
Target value tihfel a ni |
|
Material Form |
Multi-level (Low, Normal, High) tih a ni. |
Baseline level pakhat chauh a awm |
Hematology Analyzers hmantlak tak tak te
Multi-platform compatibility atana siam a ni a, he material hi multi-angle laser scatter leh fluorescence flow cytometry detection channels reticulocyte analysis atana thuam hmangin a thawk a ni.
Value / Parameter pek chhuah te
Target range hian reference run tam tak atanga lak chhuah mean assay value leh standard deviation limit (± 2SD) a entir a ni.
|
Parameter a ni |
Hlawm khat |
Level 1 (Low) Range a ni |
Level 2 (Normal) Range a ni |
Level 3 (High) Range a ni |
|
RET% 100% a ni.(Reticulocyte za zela 100) . |
% |
0.30 – 0.80 |
1.20 – 2.20 |
4.50 – 7.50 |
|
RET#(Reticulocyte chhiarna dik tak) . |
10¹²/L |
0.010 – 0.035 |
0.050 – 0.090 |
0.200 – 0.350 |
|
RBC a ni(Red Blood Cell chhiar dan) 1.1. |
10¹²/L |
1.80 – 2.40 |
3.80 – 4.40 |
4.80 – 5.40 |
|
HCT a ni(Hematocrit) a ni. |
% |
15.0 – 21.0 |
33.0 – 39.0 |
42.0 – 48.0 |
Product chungchang chi hrang hrang
|
Thil |
A sawifiahna |
|
Taksa dinhmun |
Liquid whole-thisen cell suspension a ni |
|
Vial Volume a ni |
3.0 mL / 1.0 mL a ni |
|
Packaging duhthlan tur a awm |
Tri-level combination pack emaw single-level pack emaw a ni thei |
|
Reported Parameters te chu |
RET%, RET#, RBC, HCT te a ni |
|
Value Sheet pek chhuah a ni |
Production lot khatah enclosed a ni |
|
Thil siamna hmun (Manufacturing Environment) a ni |
ISO 13485 certified a ni |
Storage & Stability a ni
A hawn loh Shelf Life:Ni 75 chhung ding chungin 2℃– 8℃ah dah a ni .
Open-Vial a nghet thei ang bera awm:Ni 14 chhung chu aseptic condition-a sample lak a nih hnuah hman zawh veleh 2℃– 8 degree-ah a kir leh nghal a ni.
Temperature Control dan tur: 1.1.Freeze suh. Eng laka venhimna hmunah dah rawh.
Quality Assurance neih a ni
Donor Screening neih dan tur: 1.1.Mihring donor source materials te chu HBsAg, anti-HCV, leh anti-HIV 1/2 te an ni tih hmuhchhuah a ni.
Lot-to-Lot inang tlang:Standardized preparation process hmang hian batch hrang hrangah cell distribution mumal tak a awm thei a ni.
Cold Chain hmanga thawn chhuah:Insulated thermal packaging hian a kal lai hian a chhung lam temperature chu 2℃– 8℃chhungah a vawng reng thin.
FAQ
Q: Sample lak hmain engtin nge material hi buatsaih tur?
A: Vial chu cold storage atangin la chhuakin minute 15 chhung room temperature (15℃- 30℃) thleng turin dah rawh. Vial chu vawi 8 atanga vawi 10 vel zawi zawiin invert la, red cells te chu a resuspended vek hma loh chuan. Cellular damage emaw bubble generation emaw ven nan aggressive shaking pumpelh tur a ni.
Q: Eng thil nge target range pawn lama value tlahniam chhan?
A: Out-of-range recovery hi mixing tling lo, refrigeration dik lo, contamination, emaw instrument optical flow cell drift atanga lo chhuak a ni fo thin.
Q: He material hi hematology instruments calibrate nan hman theih a ni em?
A: Ni lo Quality control materials hian range chhunga analytical precision verify nan a thawk a, calibration erawh chuan single-value assignment nei calibrator bik a mamawh thung.
Q: Engtin nge lot-specific target value te hi an access theih?
A: Package tin hian lot-specific assay sheet a keng tel a, chutah chuan compatible detection platform hrang hrangte tana expected mean value leh range limits tarlan a ni.
Q: Hmun hla tak-a hlat zawnga phurh chhuah chhung hian engtin nge temperature hi an vawn reng?
A: Shipment te hi thermal container-ah dah a ni a, refrigerant pack te chu transit chhung zawnga internal ambient range 2℃atanga 8℃vawng thei tura configured a ni.
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