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Consolidated Comparison of Hematology Performance Specifications

 It's 2018, do you know how good your hematology performance needs to be? Just as with chemistry and immunoassay, there's no general consensus, agreement or standardization. But here's a consolidated summary that reveals how large the discrepancies are.

 Consolidated Comparison of Hematology Performance Specifications

January 22, 2018

Hematology Analyte

Sample

Type

 Total Allowable Error GoalTEa%

TEa Source

Recommended Critical Decision Level

HGB

B

±7%

CLIA,WLSH,NYS,AAB,CAP

1, 45g/L
2, 105g/L
3, 230g/L

±6%

ESFEQA, Rilibak

±5%

MIN SPANISH EQA

±4 g/L < 100g/L
±5% > 100 g/L

IQMH

± 5 < 100
± 5% > 100
RCPA 2010

±4.19%

BV DES

HCT

B

±6%

CLIA,WLSH,NYS,AAB,CAP

1, 14%
2, 33%
3, 70%

±12%

ESFEQA

±0.02 L/L < 0.20 L/L
±7% >0.20 L/L

IQMH

±8%

MIN SPANISH EQA

±9.0%

Rilibak

± 0.04 < 20
± 20% > 0.2
RCPA 2010

±3.97%

BV Des

MCH

B

±2.5%

BV DES

1, 27pg
2, 34pg

±5.0%

MIN SPANISH EQA

±9%

ESFEQA

MCHC

B

±2.2%

BV

1, 320g/L
2, 360g/L

±7%

ESFEQA

MCV

 

±2.42%

BV DES

1, 80fL
2, 100fL

±7%

MIN SPANISH EQA

±10%

ESFEQA

± 5 < 50
± 10% > 50
RCPA 2010

±5 fL <50 fL
±5% >50 fL

IQMH

 

PLT

B

±25%

CLIA,WLSH,NYS,AAB,CAP

1, 10*10^9/L
2, 50*10^9/L
3, 100*10^9/L
4, 600*10^9/L
5, 1000*10^9/L

±13.4%

BV

±15%

ESFEQA

± 25 < 100
± 25% > 100
 

±10 x 109/L
±15%

IQMH

RBC

B

±6%

CLIA,WLSH,NYS,AAB,CAP

1, 3.5*10^12/L
2, 5.5*10^12/L

±4%

MIN SPANISH EQA

±4.4%

BV DES

±0.3*1012/L ≤4*1012/L
±8% >4*1012/L

ESFEQA

± 0.2 < 2.0
± 10% > 2.0
RCPA 2010

±0.2 x 1012/L <5.0 x 109/L
±10% > 5.0 x 109/L

IQMH

±8.0%

Rilibak

WBC

B

±15%

CLIA,AAB,CAP

1, 0.5*10^9/L
2, 3*10^9/L
3, 12*10^9/L
4, 30*10^9/L

±9%

MIN SPANISH EQA

±17.6%

BV Des

±0.7*109/L ≤4*109/L
±18% >4*109/L

ESFEQA

±0.5 x 1012/L <2.0 x 1012/L
±10% < 2.0 x 1012/L

IQMH

± 0.5 < 5.0
± 10% > 5.0
RCPA 2010

±18.0%

Rilibak

RDW

B

±1%

ESFEQA

1, 15%

MPV

B

±13%

ESFEQA

1, 8fL
2, 12.5fL

±12%

IQMH

±5.84%

BV Des

Antithrombin III

P

8.30%

BV

1, 50%
2, 75%

±8%* ≤50%  (* % is unit)
±16%*
50%  (* % means ratio)

ESFEQA

±16mg/L ≤100mg/L
±16% >100mg/L

ESFEQA

APTT

P

4.50%

BV

1, 40s
2, 90s

15%

CLIA,WLSH,NYS,AAB,CAP

± 10 < 40
± 25% > 40
RCPA 2010

18%

ESFEQA

D-Dimer

P

30%

AAB

1, 1mg/L

±0.13mg/L ≤1mg/L
±31% >1mg/L

ESFEQA

± 0.25 < 0.50
± 50% > 0.50
RCPA 2010

±0.13 FEU mg/L 1 FEU mg/L
±31% 1 FEU mg/L

ESFEQA

Fibrinogen

P

13.60%

BV DES

1, 0.3g/L
2, 1.0g/L
3, 5.0g/L

20%

CLIA,WLSH,NYS,AAB,CAP

±0.34g/L ≤ 2g/L
±17% >2g/L

ESFEQA

± 0.25 < 1.0
± 25% > 1.1
 

±24%

MIN SPANISH EQA

Prothrombin Time

P

5.30%

BV DES

1, 15s
2, 30s

15%

CLIA,WLSH,NYS,AAB,CAP

±12% ≤50%
±23% >50%

ESFEQA

±12 ≤0.5
±23% >0.5

ESFEQA

±2.3s ≤10s
±23% >10s

ESFEQA

Granuloctye count

 

±5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH

 
± 1.0 < 10.0
± 10% > 10.0
RCPA 2010

Lymphocyte count

 

±5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH

 
± 2.0 < 10.0
± 20% > 10.0
RCPA 2010

±17.6%

BV DES

Monocyte count

 

±5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH

 
± 3.0 < 10.0
± 30% > 10.0
RCPA 2010

±27.9%

BV DES

Neutrophil count

 

±23.35%

BV DES

 
± 1.0 < 10.0
± 10% > 10.0
RCPA 2010

Eosinophil count

 

±5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH

 
± 3.0 < 10.0
± 30% > 10.0
RCPA 2010

±37.1%

BV DES

Basophil count

 

±5 x 109/L < 4.0 x 109/L
±15% > 4.0 x 109/L

IQMH

 
± 3.0 < 10.0
± 30% > 10.0
RCPA 2010

±38.5%

BV DES

(automated)
Reticulocyte count

 

±33% (instrument group mean)

IQMH

 

±35% (%)

MIN SPANISH EQA

±16.5%

BV DES

 

CLIA represents the US CLIA regulations

WLSH is Wisconsin State Lab of Hygiene.

NYS represents the now defunct New York State PT requirements

AAB is the PT program of the American Association of Bioanalyts

CAP is the PT program of the College of American Pathologists

Rilibak are the German EQA performance specifications of the Rilibak rules

Min Spanish EQA are the minimum consensus performance specifications of multiple Spanish EQA surveys

IQMH is the PT program of the Institute for Quality Management in Healthcare

BV DES represents the desirable performance specifications of the Biologic Variation Database

ESfEQA is the European Society for External Quality Assessment

RCPA 2010 is the allowable limits of performance for the RCAP QAP in Haematology from 2010

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