Table 1 to Paragraph (b) -Analyte or Test
Cancer antigen (CA) 125. |
Carcinoembryonic antigen (CEA). |
Cortisol. |
Estradiol. |
Folate, serum. |
Follicle stimulating hormone. |
Free thyroxine. |
Human chorionic gonadotropin (HCG) (excluding urine pregnancy tests done by visual color comparison categorized as waived tests). |
Luteinizing hormone. |
Parathyroid hormone. |
Progesterone. |
Prolactin. |
Testosterone. |
T3 Uptake. |
Triiodothyronine. |
Thyroid-stimulating hormone. |
Thyroxine. |
Vitamin B12. |
Table 2 to Paragraph (c)(2)-Criteria for Acceptable Performance
The criteria for acceptable performance are- Analyte or test | Criteria for acceptable performance |
Cancer antigen (CA) 125 | Target value ±20%. |
Carcinoembryonic antigen (CEA) | Target value ±15% or ±1 ng/mL (greater). |
Cortisol | Target value ±20%. |
Estradiol | Target value ±30%. |
Folate, serum | Target value ±30% or ±1 ng/mL (greater). |
Follicle stimulating hormone | Target value ±18% or ±2 IU/L (greater). |
Free thyroxine | Target value or ±15% or ±0.3 ng/dL (greater). |
Human chorionic | Target value ±18% or ±3 |
gonadotropin (excluding urine pregnancy tests done by visual color comparison categorized as waived tests) | mIU/mL (greater) or positive or negative. |
Luteinizing hormone | Target value ±20%. |
Parathyroid hormone | Target value ±30%. |
Progesterone | Target value ±25%. |
Prolactin | Target value ±20%. |
Testosterone | Target value ±30% or ±20 ng/dL (greater). |
T3 uptake | Target value ±18%. |
Triiodothyronine | Target value ±30%. |
Thyroid-stimulating hormone | Target value ±20% or ±0.2 mIU/L (greater). |
Thyroxine | Target value ±20% or ±1.0 mcg/dL (greater). |
Vitamin B12 | Target value ±25% or ±30 pg/mL (greater). |
42 C.F.R. §493.933