5-Part Hematology Analyzer Control hi tri-level tri-phasic whole-blood reference material a ni a, automated differential cell counter-te dik leh dik loh enfiahna atana engineer a ni. Mihring leh sava cellular component nghet tak tak hmanga siam a ni a, thisen specimen tharte chu white blood cell differential, red blood cells, hemoglobin leh platelets hrang hrangah a entawn a ni. Production lot tin hian nitin laboratory quality control protocol zawm tur a nih theih nan instrument-specific target value a keng tel vek a ni.

Hematology Control / Calibrator te hi eng nge ni?

Hematology control leh calibrator te hi clinical laboratory-a quality management hmanraw pawimawh tak angin an thawk a, operational consumables, diluents emaw lysing reagents emaw nen a danglam hle.
Hematology Control dan tur: 1.1.Cellular suspension stable tak tak, concentration ranges pre-determined te. Nitin measurement precision endik nan, analytical drift hriatchhuah nan leh baseline system performance verify turin routine clinical samples nen test an ni.
Hematology Calibrator te chu: 1.1.Reference material characterized sang tak tak, single traceable point value nei te. System install lai emaw, maintenance lian tham neih zawh hnu emawa signal gain settings siamrem leh physical measurement baselines set nan chauh hman a ni.

Hematology Quality Control-a a chanvo

Routine quality control testing hian nitin laboratory hnathawhnaah system stability leh analytical consistency a tichiang a:

Systemic Drift hriatchhuahna:Damlo result siam hmain optical pathway misalignment, fluidic pressure inthlak danglamna, leh reagent degradation te a hmuchhuak thin.

Thil dik tak finfiahna:Tracks run-to-run leh ni-to-ni reproducibility chu standard deviation boundary siam tawh chhungah a ni.

Regulatory Record vawn dan tur: 1.1.Laboratory accreditation audit neihna atana mamawh performance record traceable a siam chhuak thin.

Differential Gating hmanga tihdikna:Leukocyte subpopulation dik taka hriat theihna turin optical scatter leh impedance gating algorithms a nemnghet.

Control Level / A hman dan tur

He reference material hi clinical measurement range kimchang takah instrument response validate turin concentration level hrang hrang pathum-ah supply a ni a:
Level hniam tak a ni
Cellular concentration pangngai aia sub-simulates. Detection limit hniam zawkah measurement sensitivity leh linearity a endik a, leukopenia, anemia, leh thrombocytopenia report dik tak a finfiah thin.
Normal Level a ni
Physiological cell count hrisel tak tak a entir. Routine system performance leh optical scatterplot verification atana nitin benchmark bulpui ber a ni.
Level sang tak a ni
Cellular concentration sang tak a simulate thin. Upper detection limit-ah signal saturation emaw cell coincidence loss emaw awm lovin measurement linearity a verify thin.

Control leh Calibrator te a ni

Control leh calibrator hrang hrangte thliar hran hian factory calibration factors-a siamthatna dik lo a veng a, test integrity a vawng reng bawk:

Hnathawh theihna Feature	Hematology Control a ni	Hematology Calibrator hmanga siam a ni
Hnathawh hmasa ber	Precision leh stability enfiah chhunzawm zel	Baseline dikna leh gain adjustment siam
Testing neih tam dan	Nitin emaw shift khatah emaw	Bi-kum tin emaw, post{1}}maintenance emaw
Value Type pek chhuah a ni	Target mean chu range tihfel (±SD) nen a ni.	Reference value pakhat chauh a awm
System-a nghawng a neih dan	Settings tihdanglam ngai lovin performance a enfiah thin	Internal calibration constant te chu direct in a update thin

Hematology Analyzers hmantlak tak tak te

Semiconductor laser scatter, flow cytometry, chemical staining, leh electrical impedance technology hmanga automated 5-part differential platform hrang hranga matrix inmil theihna tura siam a ni. Parameter channel inmil thei te chu:

Hma lam light scatter, side scatter, leh fluorescence channel te a awm bawk
Electrical impedance volume gating hmanga siam a ni
Hemoglobin awm zat hriat theihna tur colorimetric spectrophotometry hmanga enfiah a ni

Value / Parameter pek chhuah te

Lot tin hi target analytical platform-ah reference measurement procedure hmangin an enfiah thin. Assay sheet hian a hnuaia parameter 26 te tan target means leh acceptable ranges a pe a:

Bithliahna	A tawi zawngin	Parameter Hming a ni	Target Range Entirna (Normal) tih a ni.
Leukocyte awm zat	WBC a ni	Thisen Cells Var (Whir Blood Cells) te	6.5 - 8.5 × 10⁹/L
Differential % 100 a awm.	NEU% / LYM% / MON% / EOS% / BAS% a ni a, a man pawh a tlawm hle.	Leukocyte awm zat (%) 1.1.	Lot khatah din a ni
Differential Absolute a ni	NEU# / LYM# / MON# / EOS# / BAS# tih hi a ni.	Leukocyte Subpopulation (Abs) te chu a awm a.	Lot khatah din a ni
Erythrocyte awm zat	RBC a ni	Thisen sen (Red Blood Cells) a awm	4.00 - 5.00 × 10¹²/L
Hemoglobin a ni	HGB	Hemoglobin awm zat	135 - 155 g/L
Index hrang hrang a awm	HCT / MCV / MCH / MCHC te an ni	Hematocrit leh Red Cell Index te a awm bawk	Standard physiological bounds a ni
Red Cell A zau zawng	RDW-CV / RDW-SD	Red Cell Insem darh zau zawng	11.5 - 15.0 %
Platelet awm zat	PLT	Platelet awm zat	180 - 280 × 10⁹/L
Platelet Index te a awm bawk	MPV / PDW / PCT hmanga siam a ni	Platelet Index te a awm bawk	Standard physiological bounds a ni

Product chungchang chi hrang hrang

Technical lama thil neih a ni	A sawifiahna
Taksa lam Form	Suspension tui tak a ni a; a pawlh chuan a sen dum
Matrix atanga lo chhuak a ni	Mihring thisen sen (red blood cells) leh nucleated biological components te stabilized
Vial chi hrang hrang	Screw-cap vial te chu puncture-permeable septa hmanga siam a ni
Volume duhthlan tur a awm	2.0 mL / 3.0 mL / 4.0 mL a ni
Packaging Configuration hrang hrang te	Tri-level combination set emaw single-level bulk package emaw a ni
A tehna Traceability	ICSSH kaihhruaina hmanga tarlan reference kalphung

Storage & Stability a ni

Operational Parameter a ni	Kaihhruaina
A dahna Temperature a ni	2℃atanga 8℃(35℃F atanga 46℃F) thleng a ni. Freeze suh. Eng lakah venghim rawh.
Shelf Life hawn loh	2℃–8 degree-a dah a nih chuan siam chhuah atanga ni 90 chhung a ni
Open-Vial Stability a awm thei	Protocol angin sample lak a, refrigerator-a dah nghal a nih chuan ni 14 chhung a ni
Thermal Cycle tihkhawtlai a ni	Ni 14- chhunga open-vial window chhungah thermal cycle 14 thleng a awm thei

Quality Assurance neih a ni

Batch dik tak chu:ISO 13485 quality system hnuaia siam niin inter-lot variation tlem ber (CV < 2.5%) vawng reng turin a ni.

Donor Screening neih dan tur: 1.1.Source biological materials te chu standard screening assay hmangin HBsAg, anti-HCV, leh anti-HIV antibodies te chu an negative a ni.

Homogeneity thlirletna: 1.1.Production run hrang hranga random sampling hi distribution hmain statistical evaluation neih a ni.

Cold Chain hmanga thawn chhuah:Insulated shipping container te hian international transit chhungin in chhung boruak lum chu 2℃leh 8℃inkar a vawng reng thin.

FAQ

Q: Sample lak hmain vial hi engtin nge inhmeh tur?

A: Vial chu refrigerated storage atangin la chhuakin minute 15 chhung room temperature-ah dah la. Vial chu palm inkar ah vawi 8 atanga vawi 10 vel horizontal-in roll la, vawi 8 atanga vawi 10 vel zawi zawiin invert la, a hnuai lama cellular pellet chu fully resuspended a nih thu confirm rawh. Mechanical vortexing tih loh tur.

Q: Control value te chu beisei phak loha a tlak chuan eng action nge tih ngai?

A: Vial chu mit ngeiin enfiah la, hemolysis, clotting, microbial contamination emaw a awm leh awm loh enfiah rawh. Vial chu uluk takin re-mix la, assay chu ti leh rawh. Value te chu range atanga chhuak a nih chuan instrument settings i siamrem hmain reagent fluidics, temperature controls, leh background counts te enfiah hmasa phawt ang che.

Q: He product hi analyzer calibrate nan hman theih a ni em?

A: Ni lo, Controls hi precision monitoring leh routine stability checks atan bik siam a ni. Calibration atan hian calibrator material bik, reference setpoint pakhat nei a ngai a ni.

Q: Room temperature exposure hian engtin nge open-vial stability a nghawng?

A: Temperature 25℃aia sang chuan cellular degradation a ti chak hle. Sampling volume mamawh aspirate hnuah vial te chu 2℃–8℃storage ah dah leh nghal rawh.

Q: Target value hi digital format-ah a awm em?

A: Ni e. Assay value, target means, leh range te hi printed format-a pek a ni a, analyser quality control software module nena inmil download theih file angin pek a ni bawk.

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