COVID-19 Test Overview
The Color COVID-19 testing platform supports testing of various types, including at multiple laboratories.
Color may also use its own laboratory facilities to conduct testing. Information on Color’s FDA Emergency Use Authorized (EUA) COVID tests can be found below.
For all laboratory tests, the laboratory where testing is completed and the testing modality is listed in the methodology and limitation section on each individual lab report. Please refer to your lab report and the patient fact sheets for FDA EUA molecular tests for SARS-CoV-2 on the FDA website.
For at-home antigen diagnostic tests supplied through Color, please refer to the manufacturer’s information and applicable patient fact sheets. Patient fact sheets for all FDA EUA antigen diagnostic tests for SARS-CoV-2 can be found on the FDA website.
Color SARS-CoV-2 RT-LAMP Diagnostic Assay
The Color SARS-CoV-2 RT-LAMP Diagnostic Assay is a loop-mediated isothermal amplification (LAMP) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, midturbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, as well as bronchoalveolar lavage specimens collected from individuals suspected of COVID-19 by a healthcare provider, and anterior nasal swabs collected from any individual, including from individuals without symptoms or other reasons to suspect COVID-19 infection.
The test is also for use with anterior nasal swab specimens that are collected using either the Color COVID-19 Self-Swab Collection Kit or the Color COVID-19 Self-Swab Collection Kit with Saline when used consistent with their authorizations.
Testing is limited to Color Health, Inc., located at 863 Mitten Road, Burlingame, CA 94010, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a., and meets requirements to perform high-complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Color SARS-CoV-2 RT-LAMP Diagnostic Assay is intended for use by qualified laboratory personnel specifically instructed and trained in LAMP and in vitro diagnostic procedures. The Color SARS-CoV-2 RT-LAMP Diagnostic Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
24-72 hours. Turnaround time is the usual number of hours from the time a specimen is accessioned at the laboratory to when the result is released to the ordering provider. Test results are most typically reported electronically, which generally allows for faster delivery. Schedules may vary.
- Color COVID-19 Self-Swab Collection Kit with Saline. Instructions for Use.
- Color COVID-19 Self-Swab Collection Kit. Instructions for Use.
- Color COVID-19 Self-Swab Collection Kit DTC. Fact sheet for patients. Instructions for Use.
- Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC. Fact sheet for patients. Fact sheet for healthcare providers.
- Color SARS-CoV-2 RT-LAMP Diagnostic Assay. Fact sheet for patients. Fact sheet for healthcare providers.
- This test has currently been validated for use with AN, NP, and OP swabs.
- Acceptable transport media include: DNA/RNA shield, VTM or UTM, 1ml minimum.
- Samples can also be sent “dry” (a swab with no media, in a sterile tube), using a Color-provided collection kit.
- Storage and Transport Instructions
- Ship all samples as Category B (UN3373 – Biological Substances) material.
- Specimens collected without media (dry swabs) or swabs collected in DNA/RNA shield may be handled and shipped at room temperature.
- VTM and UTM should be refrigerated at 2-8℃ prior to and during transport within 24 hrs. If the specimen is to be submitted greater than 24 hrs post collection, freeze the specimens at -20℃ or below and then ship on dry ice.
- Sample may be rejected or significantly delayed if they arrive with:
- Insufficient, incompatible or congealed media in specimens collected in transport media
- Dry swabs that arrive more than 56 hours after sample collection
- Improperly capped or labeled tubes
- Swabs inverted in collection tubes (i.e. swab bud facing up)
- Missing physician order
- Incomplete or missing patient information
- Not in compliance with Color’s Terms of Service
- Detection of SARS-CoV-2 to assist in the diagnosis of COVID-2019 infections
- Result types:
- Positive for SARS-CoV-2. Positive indicates that SARS-CoV-2 (the virus that causes COVID-19) was detected in the patient’s sample. False positives are possible.
- Negative for SARS-CoV-2. Negative indicates that SARS-CoV-2 (the virus that causes COVID-19) was not detected in the patient’s sample. False negatives are possible.
- Inconclusive result for SARS-CoV-2. Inconclusive indicates that the test results were internally inconsistent and cannot be classified as either positive or negative.
- Unsatisfactory sample. Test could not be completed.
- Test method for Color SARS-CoV-2 Amplification Assay
- This test was developed and its performance characteristics determined by Color Genomics, Inc. (“Color”), a clinical laboratory accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing (CAP #8975161 – CLIA #05D2081492).
- RNA is extracted from the primary sample and analyzed using a colorimetric loop-mediated isothermal amplification (LAMP) based assay. The presence of SARS-CoV-2 is assessed by analyzing two viral targets (N & E genes, or Orf1A & S genes). The human RNAseP gene is analyzed as an extraction control.
- Test Limitations include:
- This assay has a >99% accuracy with a limit of detection of 0.75 copies/uL for samples processed up to 72 hours from collection time.
- Positive results are indicative of an active infection with SARS-CoV-2 but do not rule out bacterial infections or co-infection with other viruses. Negative results do not eliminate the possibility of a SARS-CoV-2 infection.
- The sample collection technique can meaningfully impact test sensitivity. False positives and false negatives are possible. False negatives can occur for several reasons including (but not limited to) reduced sensitivity due to a viral load below the limit of detection of this assay, or mutations in the targeted viral sequence, or the presence of amplification inhibitors.