SMILE Minimum Recommended Validation requirements for

Chemistry Total Allowable Error (TEa)

SMILE Total Error Limits (whichever is greater) Precision

Minimum detectable
Analyte Short Term Long Term
Percentage difference or absolute
25% TE 33% TE
value
±0.2 g/dL
Albumin ± 10% (1) 2.5% 3.3%
2.0 g/L (4)
Alk. Phos ± 30% (1) ±5.0 U/L (4) 7.5% 9.9%

ALT ± 20% (1) ±5.0 U/L (4) 5.0% 6.6%

Amylase ± 30% (1) ±5.0 U/L (4) 7.5% 9.9%

AST ± 20% (1) ±5.0 U/L (4) 5.0% 6.6%

± 0.4 mg/dL
Bilirubin, Direct ± 20% (2) 5.0% 6.6%
6.84 umol/L (2)
± 0.4 mg/dL
Bilirubin, Total ± 20% (1) 5.0% 6.6%
6.84 umol/L (1)
± 1.0 mg/dL
Calcium ± 8.3% (4) 2.08% 2.74%
0.25 mmol/L (1)
Chloride ± 5% (1) ±2.0 mmol/L (4) 1.25% 1.65%
±3.0 mg/dL
Cholesterol ± 10% (1) 2.50% 3.3%
0.08 mmol/L (4)
CO2 ± 20% (4) ±4.0 mmol/L (10) 5.00% 6.6%
± 0.3 mg/dL
Creatinine ± 15% (1) 3.75% 4.95%
26.52 µmol/L (1)
Creatine Kinase ± 30% (1) ±5.0 U/L (4) 7.5% 9.9%
± 16.5 ng/mL
Ferritin ± 16.9% (3) 4.2% 5.58%
16.5 µg/L (6)
± 0.3 ng/mL
Folate ± 30% (6) 7.50% 9.90%
0.68 nmol/L (6)
GGT ± 25% (4) ± 5.0 U/L (4) 6.25% 8.25%
Glucose ± 6.0 mg/dL
± 10% (1) 2.50% 3.3%
(serum and CSF) 0.33 mmol/L (1)
± 5.0 mIU/mL
hCG Quant ± 25% (8) 6.25% 8.25%
5.0 IU/L (8)
± 2.0 mg/dL
HDL Cholesterol ± 30% (1) 7.5% 9.9%
0.05 mmol/L (4)
HbA1c ± 6% (12) Not available 1.5% 2.0%
± 5.0 µg/dL
Iron ± 20% (1) 5.0% 6.6%
0.89 µmol/L (4)
Iron Binding
± 20% (2) Not available 5.0% 6.6%
Capacity (TIBC)
Iron Binding
± 20% (2) Not available 5.0% 6.6%
Unsaturated
Lactate ± 10% (9) ± 0.2 mmol/L (9) 2.5% 3.3%
Lactate
± 20% (1) ±5.0 U/L (4) 5.0% 6.6%
Dehydrogenase
LDL-Chol. Calc ± 30% (5) Not available 7.5% 9.9%

LDL-Chol. Meas. ± 30% (2) Not available 7.5% 9.9%

Lipase ± 30% (2) ±8.0 U/L (4) 7.5% 9.9%

±0.2 mg/dL
Magnesium ±25% (1) 6.25% 8.25%
0.08 mmol/L (4)
± 0.3 mg/dL
Phosphorus ±10.7% (2) 2.68% 3.53%
0.097 mmol/L (2)
Potassium ± 12.3%* (4) ± 0.5 mmol/L (1) 3.08% 4.06%
Protein, Total ± 0.2 g/dL
±10% (1) 2.5% 3.3%
(Serum) 2.0 g/L (4)
Protein, Total (CSF) ±20% (11) Not available 5.0% 6.6%

Sodium ± 3.1%* (4) ± 4.0 mmol/L (1) 0.78% 1.32%

±5.0 mg/dL
Transferrin ±20% (2) 5.0% 6.6%
0.05 g/L (7)
±4.0 mg/dL
Triglycerides ±25% (1) 6.25% 8.25%
0.05 mmol/L (4)
± 2.0 mg N/dL
Urea (BUN) ±9% (1) 2.25% 2.97%
0.714 mmol/L (1)
±0.5 mg/dL
Uric Acid ±17% (1) 4.25% 5.61%
30 µmol/L (4)
±30 pg/mL
Vitamin B-12 ± 30% (6) 7.5% 9.9%
22.2 pmol/L (6)

References:
1) http://www.westgard.com/clia.htm
2) http://www.cap.org, CAP2008 C-B General Chemistry Participant Summary Evaluation Criteria
3) http://www.westgard.com/biodatabase1.htm DESIRABLE SPECIFICATIONS FOR TOTAL ERROR, IMPRECISION, AND BIAS, DERIVED
FROM BIOLOGIC VARIATION, Ricos C, Alvarez V, et. al "Current databases on biologic variation: pros, cons and progress." Scand J Clin Lab
Invest 1999;59:491-500. Annex I, Part I: Within-subject and between-subject CV values of analytes and Desirable Analytical Quality Specifications
for imprecision, bias and total error

4) http://www.cap.org, CAP2007 LN2-B Chemistry Linearity and Calibration Verification Participant Summary Evaluation Criteria
5) Based on LDL-Measured criteria as determined in (2) CAP2008 C-B General Chemistry Participant Summary Evaluation Criteria
6) http://www.cap.org, CAP2007 LN5-B Chemistry Linearity and Calibration Verification Participant Summary Evaluation Criteria
7) http://www.cap.org, CAP2007 LN7-B Chemistry Linearity and Calibration Verification Participant Summary Evaluation Criteria
8) http://www.cap.org, CAP2007 LN8-B Chemistry Linearity and Calibration Verification Participant Summary Evaluation Criteria
9) Maine Standards, Evaluation criteria for Validate Lactate linearity product, MSDRx Rev. 6.4
10) Accutest PT Evaluation Criteria
11) http://www.cap.org, CAP2010 M-A Cerebrospinal Fluid Chemistry and Oligoclonal Bands Participant Summary Evaluation Criteria
12) http://www.ngsp.org, National Glycohemoglobin Standardization Program (NGSP)

020_SMILE Performance Criteria for DAIDS Analytes v.1.3 6/5/2019