CBC Analyzer Calibrator hian automated hematology analyzers calibrate nan measurement value dik tak, traceable a pe a, WBC, RBC, HGB, MCV, leh PLT te pawh telna parameter hrang hrangte tan baseline accuracy a siam a ni.

Hematology Control / Calibrator te hi eng nge ni?

Hematology control leh calibrator te hi specialized, reference-grade biological materials an ni a, laboratory measurement standards vawng reng tura engineer an ni.

Calibrator-ah hian hematology analyzer-te baseline measurement scaling set leh adjust-na atana hman cellular components concentration hriat tawhte a awm a.
Controls chu nitin emaw shift-by{1}}shift basis-a hman thin stable test sample a ni a, calibration siam a nih hnua precision kal zel leh system reproducibility enfiah nan hman thin a ni.

Run cycle pangngaia cell processing ti thin general operational reagent ang lo takin, calibrator leh control te hi analytical verification leh quality compliance atana mamawh quantitative reference standard angin an thawk a ni.

Hematology Quality Control-a a chanvo

Thisen zat test kimchang takah analytical accuracy vawng reng tur chuan systematic reference adjustment a ngai a ni.
A tehna Traceability: 1.1.Optical leh electrical impedance channel te chu international level-a hriat hlawh reference method nen a inmil tir thin.
Post-Enkawlna Recalibration:Optical adjustment, fluidic component thlak, sensor recalibration, emaw major instrument servicing emaw hnuah system dikna a siam tha leh thin.
Reagent Lot siamthat dan tur:Working reagent siamna lot hrang hrang inkara transition a nih hian baseline optical shift a siam tha.
Regulatory zawm dan: 1.1.Laboratory accreditation framework hnuaia standard operating procedure mamawh a hlen chhuak.

Control Level / A hman dan tur

Calibration hnua quality control routine kimchang tak neih theih nan hematology control system te hi physiological concentration hrang hrang pathum ah an thawk a:

Level hniam zawk:Cell count hniam tak takah instrument sensitivity a evaluate thin. Anemia na tak, leukopenia, leh thrombocytopenia te clinical decision thresholds validate na atan a pawimawh hle.

Level pangngai: 1.1.Routine patient screening atan standard physiological range chhunga measurement dikna a enfiah thin.

Level sang tak: 1.1.Leukocytosis, erythrocytosis, thrombocytosis neih laiin cellular concentration sang takah analyzer detector response a test thin.

Control leh Calibrator te a ni

Technical Parameter a ni	CBC Analyzer Calibrator hmanga siam a ni	Hematology Control (A hniam / A pangngai / A sang) 1.1.
Hnathawh hmasa ber	Instrument baseline a siamrem a, response factors a set bawk	Measurement kalpui mek precision leh stability a verify thin
A hman dan Frequency	Periodic (Installation, enkawl dan, reagent lot thlak danglam) 1.1.	Nitin, shift-based, emaw test batch khatah emaw
Target Value te chu a ni	Parameter khatah assignment value fixed pakhat chauh a awm a, limit tawi tak a awm bawk	Defined value hi concentration hniam, pangngai leh sang zawng zawngah a awm a
Mathematics lama a chanvo	System memory-a calibration slope leh intercept a thlak danglam thin	Levey-Jennings chart-ah data point a plot a, drift a hriat theih nan
Metroological Standard hmanga tehfung siam a ni	Primary emaw secondary emaw reference material standard emaw a ni	Secondary quality enfiahna hmanrua a ni

Hematology Analyzers hmantlak tak tak te

Thisen pum sample characteristic nena inmil tura stabilized biological components hmanga siam, instrument platform hrang hranga integration thlawptu:

3-Part Differential System hrang hrang: 1.1.Impedance-based counter hrang hrangah WBC, RBC, HGB, HCT, MCV, MCH, MCHC, leh PLT te calibration mamawh a ni.

5-Part Differential System hrang hrang: 1.1.Multi-angle laser scatter, flow cytometry, leh chemical staining platform hrang hrangah sub-population zawng zawngah differential calibration a ngai a ni.

Value / Parameter pek chhuah te

Lot tin hi reference method hmanga validate a ni a, target value leh acceptable range awmna lot-specific Assay Value Sheet nen supply a ni:

Parameter a ni	A tawi zawngin	Target Range pangngai (Typical Target Range) a ni	Unit ruat a ni
Thisen Cells Var (Whir Blood Cells) te	WBC a ni	6.5 - 8.5	x10^9/L
Thisen sen (Red Blood Cells) a awm	RBC a ni	4.00 - 5.00	x10^12/L
Hemoglobin a ni	HGB	120 - 150	g/L
Corpuscular Volume tih awmzia chu a ni	MCV a ni	80.0 - 95.0	fL
Platelets a awm	PLT	180 - 280	x10^9/L

Product chungchang chi hrang hrang

Specification Item a ni	Kimchang
Product Hming	CBC Analyzer Calibrator hmanga siam a ni
Formulation siam dan tur	Preservative medium-ah cellular suspension tihngheh a ni
Taksa dinhmun	Liquid suspension a ni
Parameters pek chhuah te	WBC, RBC, HGB, MCV, PLT, HCT te an ni
Volume chu fill rawh	Vial khatah 2.0 mL / 3.0 mL a ni
Traceability a awm bawk	International reference standard-te sawina a ni
Thil siam chhuahna Certification neih a ni	ISO 13485 a ni
Packaging duhthlan tur a awm	Multi-vial kits tam tak-specific barcode assay sheet nei

Storage & Stability a ni

Temperature control hian product dam chhung zawngin cell membrane integrity leh parameter stability a humhim a:

A hawn loh Storage Temperature: 1.1.2 atanga 8℃Celsius thleng a ni. Freeze suh.

A hawn loh Shelf Life:2 atanga 8℃Celsius-a dah a nih chuan siam chhuah atanga ni 60 chhung a ni.

Open-Vial a nghet thei ang bera awm:Ni 7 chhung chu sample lak zawh veleh 2 to 8℃Celsius-ah nghet taka sealed a nih chuan.

Thermal atanga invenna: 1.1.Transit laiin thermal stability humhim turin temperature-monitored insulated packaging-ah thawn chhuah a ni.

Quality Assurance neih a ni

Manufacturing protocols hian lot-to-lot consistency leh measurement verification a vawng reng thin:

Metroological hmanga finfiahna:Calibration lot tin hi international standard nena inmil reference instrument hmanga value pek an ni.

Homogeneity Testing hmanga thil tih dan: 1.1.Production cycle hrang hranga random vial sampling hian intra-lot consistency (Coefficient of Variation) a finfiah a ni<= 1.0%).

Stability enfiahna: 1.1.Production batch tinah real-time leh accelerated stability testing tih a ni.

Regulatory Documentation te chu a hnuaia mi ang hian a ni.Delivery lot tinah Certificate of Analysis leh Safety Data Sheet pek tur a ni.

FAQ

Q: Analyzer hi engzat nge calibrator hmanga calibrate tur?

A: Recalibration hi instrument installation hmasa berah, routine preventive maintenance zawhah, siamthatna lian tham hnuah, nitin quality control result-in consistent bias a lantir hunah emaw, laboratory protocol angin reagent lot thara inthlak hunah emaw a ngai a ni.

Q: Open-vial stability leh unopened shelf life hi eng nge a danglamna?

A: Unopened shelf life tih hian calibrator-in 2 to 8℃Celsius-a sealed-a dah a nih laiin assigned value a vawn reng chhung a kawk a ni. Open-vial stability hian a hawn hnua ni engzat nge a dik reng tih a tarlang a, chu chu boruak thianghlim hnuaia enkawl a nih a, hman zawh veleh℃Celsius 2 atanga 8 thlenga dah leh nghal a nih phawt chuan.

Q: Calibrator aiah hematology control hman theih a ni em?

A: Ni lo. Controls hian numerical range hrang hrangah system precision a enfiah a, calibrator erawh chuan analyzer software-in mathematical response curve leh baseline calibration factors siamremna atana a hman tur reference value dik tak a pe thung.

Q: Sampling hmain calibrator hi engtin nge siam tur?

A: Vial chu℃Celsius 2 atanga 8 thlenga dahna atanga la chhuakin room temperature (15 to 30℃Celsius) ah minute 15 chhung equilibrate turin dah la. Sample chu sampling probe-ah i hlan hmain inversion nem tak, kimchang tak hmangin uluk takin mix rawh. Cell tihbuai emaw, boruak bubble emaw awm loh nan tihnghing loh tur.

Q: International shipping neih chhung hian engtin nge temperature hi an vawn reng?

A: Order te hi thermal packaging-ah temperature-insulating materials leh cold pack-ah dah a ni a, air transit chhung zawnga℃Celsius 2 atanga 8 thlenga awm thei tura duan a ni.

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