Bio-Rad Laboratories
9500 Jeronimo Road, 92618, Irvine, CA, United States
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What this lab is accredited for
We could not match the method references in this lab’s scope to published test standard numbers. The full scope as published is below.
Only this lab. Searches the method, matrix and range of each of the 10 scope lines.
A2LA certificate 3233.01 · 10 lines
| Line | Method | Matrix | Range |
|---|---|---|---|
| 1 | ISO/IEC 17043:2010 | Blood | - |
| 2 | isol 21 | Blood | - |
| 3 | - | human plasma with added chemicals and stabilizersShow page textExtracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3233.01) Revised 9/10/2024 Page 3 of 9
PROGRAM NAME FREQUENCY ANALYTES MEASURED1
Clinical Chemistry
(Monthly) Program
(Continued)
22. Creatinine
23. Gamma Glutamyl Transferase (GGT)
24. Glucose
25. Iron
26. Iron Binding Capacity, Total (TIBC)
27. Iron Binding Capacity, Unsaturated
(UIBC)
28. Lactate (Lactic Acid)
29. Lactate Dehydrogenase (LDH)
30. Lipase
31. Lithium
32. Magnesium
33. Osmolality
34. Phosphorus
35. Potassium
36. Protein (Total)
37. Sodium
38. Thyroid Stimulating Hormone (TSH)
39. Thyroxine (T4), Free
40. Thyroxine (T4), Total
41. Transferrin
42. Triglycerides
43. Triiodothyronine (T3), Free
44. Triiodothyronine (T3), Total
45. Urea
46. Urea Nitrogen
47. Uric Acid
48. Zinc
49. Bile Acid
Coagulation Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These lyophilized proficiency samples are
prepared from human plasma with added
chemicals and stabilizers.
Analytes:
1. Activated Partial Thromboplastin Time
(APTT)
2. Antithrombin III (ATIII)
3. D-dimer
4. Factor VIII
5. Fibrinogen
6. International Normalized Ratio (INR)
7. Prothrombin Time (PT)
8. Protein C
9. Protein S
10. Thrombin Time (TT)
11. Von Willibrand Factor (vWF) | - |
| 4 | - | BloodShow page textExtracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3233.01) Revised 9/10/2024 Page 4 of 9
PROGRAM NAME FREQUENCY ANALYTES MEASURED1
Ethanol/Ammonia
Program
One distribution of 12
samples every 12
months.
One sample to be tested
every month.
These liquid proficiency samples are prepared
from human serum and purified chemicals
with added preservatives and stabilizers.
Analytes:
1. Ethanol
2. Ammonia
Hematology Program
Four distribution of 3
samples every 12
months. One sample to
be tested every month.
These liquid proficiency samples are prepared
from human erythrocytes, mammalian
leukocytes and platelets with preservatives.
Analytes:
1. Hematocrit (HCT)
2. Hemoglobin (Total)
3. Mean Corpuscular Hemoglobin (MCH)
4. Mean Corpuscular Hemoglobin
Concentration (MCHC)
5. Mean Corpuscular Volume (MCV)
6. Mean Platelet Volume (MPV)
7. Platelets (PLT)
8. Red Blood Cells (RBC)
9. Red Blood Cell Distribution Width
(RDW)
10. Red Blood Cell Distribution Width
Standard Deviation (RDW-SD)
11. White Blood Cells (WBC)
Hemoglobin Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These lyophilized proficiency samples are
prepared from human whole blood with
added stabilizers and preservatives.
Analytes:
1. Hemoglobin A1C
2. Hemoglobin A2
3. Hemoglobin (Total Glycated)
HIV/Hepatitis Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These liquid samples are prepared with
human source material with added
constituents of animal origin and
preservatives.
Analytes:
1. Anti HAV
2. HAV IgG
3. HAV IgM
4. Anti HBc
5. HBc IgM
6. Anti HBe | - |
| 5 | isol 2; isol 18 | human serum with added constituents of human and animal origin, chemicals and therapeutic drugs | - |
| 6 | - | human serumShow page textExtracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3233.01) Revised 9/10/2024 Page 6 of 9
PROGRAM NAME FREQUENCY ANALYTES MEASURED1
Immunoassay (Monthly)
Program (Continued)
One distribution of 12
samples every 12
months. One sample to
be tested every month.
38. Prolactin
39. Prostate Specific Antigen (PSA), Free
40. PSA- Free/Total (Ratio)
41. Prostate Specific Antigen (PSA), Total
42. Renin (Direct)
43. S100 Protein
44. Sex Hormone Binding Globulin (SHBG)
45. T-Uptake
46. T3 Uptake
47. Testosterone
48. Theophylline
49. Thyroglobulin (Tg)
50. Thyroid Stimulating Hormone (TSH)
51. Thyroxine (T4), Free
52. Thyroxine (T4), Total
53. Thyroxine Binding Globulin (TBG)
54. Transferrin
55. Triiodothyronine (T3), Free
56. Triiodothyronine (T3), Total
57. Valproic Acid
58. Vitamin B12
59. Fructosamine
60. Free Testosterone
Lipids Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These liquid proficiency samples are prepared
from human serum with added constituents of
human origin, preservatives and stabilizers.
Analytes:
1. Apolipoprotein A1
2. Apolipoprotein B
3. Cholesterol, HDL
4. Cholesterol, LDL
5. Cholesterol, Total
6. Triglycerides
7. Lipoprotein(a)
Serum Proteins Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These lyophilized proficiency samples are
prepared from human serum with added
constituents of animal origin, chemicals
Analytes:
1. α -1-Acid Glycoprotein
2. α-1 Antitrypsin
3. α-2 Macroglobulin
4. β-2 Microglobulin
5. Albumin
6. Antistreptolysin O (ASO)
7. C-Reactive Protein (CRP)
8. Ceruloplasmin
9. Complement C3
10. Complement C4 | - |
| 7 | - | defibrinated human plasma; human source materialShow page textExtracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3233.01) Revised 9/10/2024 Page 7 of 9
PROGRAM NAME FREQUENCY ANALYTES MEASURED1
Serum Proteins Program
(Continued)
One distribution of 12
samples every 12
months. One sample to
be tested every month.
11. Haptoglobin
12. Immunoglobulin A (IgA)
13. Immunoglobulin E (IgE)
14. Immunoglobulin G (IgG)
15. Immunoglobulin M (IgM)
16. Kappa Light Chain
17. Lambda Light Chain
18. Prealbumin
19. Protein (Total)
20. Rheumatoid Factor
21. Transferrin
Specialty Immunoassay
Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These liquid proficiency samples are prepared
from defibrinated human plasma with added
chemicals, constituents of human and animal
origin, stabilizers and preservatives.
Analytes:
1. 25-Hydroxy Vitamin D
2. Active B12/HoloTC
3. Anti-Thyroglobulin (Anti-Tg)
4. Anti-Thyroperoxidase (Anti-TPO)
5. C-Peptide
6. Erythropoietin (EPO)
7. Fructosamine
8. IGF-1/Somatomedin C
9. Interleukin-6 (IL-6)
10. Osteocalcin
11. Procalcitonin
12. PTH (Intact)
13. TSH Receptor Antibody (TRAb)
Syphilis/Chagas Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These liquid samples are prepared from
human source material with added
preservatives.
Analytes:
1. Non-Treponemal Antibodies
2. Treponema pallidum IgG
3. Treponema pallidum Antibodies
4. Trypanosoma cruzi
Antibodies
Therapeutic Drug
Monitoring Program
One distribution of 12
samples every 12
months. One sample to
be tested every month
These lyophilized proficiency samples are
prepared from defibrinated human plasma
with added chemicals and therapeutic drugs.
Analytes:
1. Acetaminophen
2. Amikacin
3. Amitriptyline
4. Caffeine
5. Carbamazepine
6. Cyclosporine
7. Digoxin | - |
| 8 | - | BloodShow page textExtracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3233.01) Revised 9/10/2024 Page 8 of 9
PROGRAM NAME FREQUENCY ANALYTES MEASURED1
Therapeutic Drug
Monitoring Program
(Continued)
One distribution of 12
samples every 12
months. One sample to
be tested every month
8. Ethosuximide
9. Gentamicin
10. Lithium
11. Methotrexate
12. Nortriptyline
13. Phenobarbital
14. Phenytoin
15. Primidone
16. Salicylate
17. Theophylline
18. Tobramycin
19. Tricyclic Antidepressants (TCA) Screen
20. Valproic Acid
21. Vancomycin
ToRCH/EBV/MuMZ
Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These liquid samples are prepared from
human source material with added
preservatives.
Analytes:
1. Cytomegalovirus (CMV) IgG
2. Cytomegalovirus (CMV) IgM
3. Epstein-Barr Virus (EBNA) IgG
4. Epstein-Barr Virus (VCA) IgG
5. Epstein-Barr Virus (VCA) IgM
6. Herpes Simplex Virus (HSV-1) IgG
7. Herpes Simplex Virus (HSV-2) IgG
8. Herpes Simplex Virus (HSV1/2) IgG
9. Measles Virus (Rubeola) IgG
10. Mumps Virus IgG
11. Rubella Virus IgG
12. Rubella Virus IgM
13. Toxoplasma gondii (Toxo) IgG
14. Toxoplasma gondii (Toxo) IgM
15. Varicella Zoster Virus (VZV) IgG
Urinalysis Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These liquid samples are prepared with
human erythrocytes, constituents of animal
origin, chemicals, and preservatives.
Analytes:
1. Albumin
2. Albumin-to-Creatinine Ratio
3. Bilirubin
4. Blood (Hemoglobin)
5. Creatinine
6. Glucose
7. Human Chorionic Gonadotropin (hCG)
8. Ketones | - |
| 9 | - | UrineShow page textExtracted from the scope document; tables may not line up. View scope for the original. (A2LA Cert. No. 3233.01) Revised 9/10/2024 Page 9 of 9
PROGRAM NAME FREQUENCY ANALYTES MEASURED1
Urinalysis Program
(continued)
One distribution of 12
samples every 12
months. One sample to
be tested every month.
9. Leukocytes
10. Nitrites
11. pH
12. Protein (Total)
13. Protein-to-Creatinine Ratio
14. Specific Gravity
15. Urobilinogen
Urine Chemistry Program
One distribution of 12
samples every 12
months. One sample to
be tested every month.
These lyophilized proficiency samples are
prepared from human urine with added
chemicals, hormones and stabilizers.
Analytes:
1. 5-Hydroxyindoleacetic Acid (5-HIAA)
2. Calcium (Total)
3. Chloride
4. Cortisol (Free)
5. Creatinine
6. Dopamine
7. Epinephrine
8. Glucose
9. Homovanillic Acid (HVA)
10. Magnesium
11. Metanephrine
12. Microalbumin
13. Norepinephrine
14. Normetanephrine
15. Osmolality
16. Phosphorus
17. Potassium
18. Protein Total
19. Sodium
20. Urea Nitrogen
21. Uric Acid
22. Vanillylmandelic Acid (VMA)
1Analytes/parameters in each program are targeted per defined specifications. Assigned values and
associated uncertainties are known values with results determined by finished product testing of proficiency
program. | - |
| 10 | ISO/IEC 17043: 2010 | - | - |
Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
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