This document describes the scope of services for Color Diagnostics Laboratory.
Color Diagnostics is located at
863 Mitten Road, Burlingame, CA 94010
Color Diagnostics is CLIA certified, CAP accredited and holds additional state licensure.
CAP 8975161
CLIA 05D2081492
California CDF 00346276
Maryland 2376
New York PFI 9069
Pennsylvania 034727
Rhode Island LCO00970
Washington D.C. HFD-OS38
The hours of operation for Color Diagnostics are:
Monday- Friday, 6AM- 5PM
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Test Offered: |
FIT Test |
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Instrument/Method: |
Polymedco OC-Auto SENSOR io - Immunoassay |
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Specimen Type: |
Stool |
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Specimen Container and Collection: |
iFOB/FIT sample collection container from Polymedco, FIT test stool collection instructions |
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Sample Stability and Shipping: |
Room Temperature, 15 days |
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TAT: |
5 days |
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Reportable Range: |
Negative, Positive |
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Test Offered: |
HPV Test |
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Instrument/Method: |
BD Viper LT |
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Specimen Type: |
Urine |
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Specimen Container and Collection: |
Collipee, HPV Instructions |
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Sample Stability and Shipping: |
Room Temperature, 7 days |
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TAT: |
5 days |
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Reportable Range: |
Negative, Positive |
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Test Offered: |
Hereditary Cancer Risk Test |
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Instrument/Method: |
Illumina Novaseq 6000 |
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Specimen Type: |
Saliva, Whole Blood |
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Specimen Container and Collection: |
Saliva: Oragene 510 Saliva Collection kit
Whole Blood: K2 EDTA, lavender top Refer to manufacturer’s recommendations for collection of venous blood into K2 EDTA tube with a licensed or approved individual. No centrifugation is necessary. |
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Sample Stability and Shipping: |
Saliva: Room Temperature or Refrigerated, 12 months.
Blood: Room Temperature, 7 days. Refrigerated or Frozen, 6 months. |
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TAT: |
6 Weeks |
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Reportable Range: |
Variable (ask for specifics) |
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Test Offered: |
Color Extended (29 cancer, 30 heart, 20 medication response) |
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Instrument/Method: |
Illumina Novaseq 6000 |
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Specimen Type: |
Saliva, Whole Blood |
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Specimen Container and Collection: |
Saliva: Oragene 510 Saliva Collection kit
Whole Blood: K2 EDTA, lavender top Refer to manufacturer’s recommendations for collection of venous blood into K2 EDTA tube with a licensed or approved individual. No centrifugation is necessary. |
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Sample Stability and Shipping: |
Saliva: Room Temperature or Refrigerated, 12 months.
Blood: Room Temperature, 7 days. Refrigerated or Frozen, 6 months. |
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TAT: |
6 Weeks |
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Reportable Range: |
Variable (ask for specifics) |
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Test Offered: |
Color Standard (7 cancer, 3 heart, 20 medication response) |
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Instrument/Method: |
Illumina Novaseq 6000 |
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Specimen Type: |
Saliva, Whole Blood |
|
Specimen Container and Collection: |
Saliva: Oragene 510 Saliva Collection kit
Whole Blood: K2 EDTA, lavender top Refer to manufacturer’s recommendations for collection of venous blood into K2 EDTA tube with a licensed or approved individual. No centrifugation is necessary. |
|
Sample Stability and Shipping: |
Saliva: Room Temperature or Refrigerated, 12 months.
Blood: Room Temperature, 7 days. Refrigerated or Frozen, 6 months. |
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TAT: |
6 Weeks |
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Reportable Range: |
Variable (ask for specifics) |
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Test Offered: |
Color Total PSA Test |
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Instrument/Method: |
Abbott Alinity i |
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Specimen Type: |
Serum |
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Specimen Container and Collection: |
SST Tubes with Gel and Clot Activator
Capillary Blood: Tasso Blood Collection Instructions
Venous Blood: Refer to manufacturer’s recommendations for collection of venous blood into SST tube with a licensed or approved individual. Sample should be spun down within 2 hours of collection. |
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Sample Stability and Shipping: |
Capillary Blood: Room Temperature (20-35℃), 10 days. Refrigerated: 14 days. Additional cold storage (4℃) stability of 3 days after spun down.
Venous Blood: Serum has sample stability of 24 hours at 2 to 8°C |
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TAT: |
5 days |
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Reportable Range: |
0.1 - 40.0 ng/mL |