The Color Lab Network supports testing at multiple laboratories. The laboratory where testing is completed is listed in the methodology and limitation section on each individual report. Test details for each laboratory are described below:
Color Health
Assay Overview
The Color SARS-CoV-2 RT-LAMP Diagnostic Assay is a real time reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus collected in respiratory swabs. Testing is performed at the Color laboratory which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Results are intended for the detection of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in the upper respiratory system during the acute phase of infection. Positive results are indicative of active infection with SARS-CoV-2 but do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of illness. In addition, nucleic acid detection can persist following clearance of active viral replication. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities, and in some jurisdictions (including where Color is located), all results (positive, negative, and indeterminate) will be reported to local public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Testing with the Color SARS-CoV-2 RT-LAMP Diagnostic Assay is intended for use by trained and competency-certified clinical laboratory personnel, specifically instructed and trained in the techniques and in vitro diagnostic procedures. The Color SARS-CoV-2 RT-LAMP Diagnostic Assay has been validated in accordance with the FDA’s Guidance Document (Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff Document) issued on March 16, 2020 (the “FDA Guidance of March 16, 2020”). This Test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by the Color lab, but is not FDA cleared or approved. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Expected Turnaround Time
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.
Related Documents
Specimen Requirements
- Specimen
- This test has currently been validated for use with AN, NP, and OP swabs.
- Media
- 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
Test Details
- Use:
- 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.
LetsGetChecked (Priva Path Labs)
Test Performed at: 222 E Huntington Dr, Monrovia, CA 91016
CLIA #: 05D2180792
Test Methodology & Limitations
The LetsGetChecked Coronavirus (COVID-19) Test is indicated for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples containing up to 5 anterior nasal swab specimens per pool that were collected in individual vials containing transport media using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit from any individual (age 2 years and older), including individuals without symptoms or other reasons to suspect COVID-19. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in anterior nasal swabs during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with medical history and other diagnostic information is necessary to determine 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 sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Specimens collected at home from SARS-CoV-2 positive individuals may yield negative results if the specimen was not collected properly.
Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result and if results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive or invalid result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.
Negative test results from specimens collected with the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit are delivered to the user via email, phone message and through an online portal. Individuals with positive and invalid results will be contacted by a healthcare provider. The direct to consumer home collection system is intended to enable users to access information about their COVID19 infection status that could aid with determining if self-isolation or quarantine is appropriate and to assist with healthcare decisions after discussion with a healthcare provider.
HealthQuest Esoterics
Test Performed at: 6 Bendix, Irvine, CA 92618
CLIA #: 05D2088507
Test Methodology & Limitations
Results are for the detection and identification of SARS-CoV-2 RNA. The SARS-CoV2 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 positive 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 treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Broad Institute’s Clinical Research Sequencing Platform (CRSP)
Samples tested at the Broad Institute’s Clinical Research Sequencing Platform (CRSP) are processed using the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay. The assay is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs collected from individuals who may have contracted the virus. Testing is limited to the Clinical Research Sequencing Platform at the Broad Institute which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Further details about this assay can be found here.
MedLab2020, Inc
Test Performed at: 200 Forest Ave Palo Alto, 94301
CLIA #: 05D2245360
Test Methodology & Limitations
TaqPath COVID-19 RNase P Combo Kit 2.0: This test has not been FDA cleared or approved. This test has been validated under an Emergency Use Authorization (EUA) guidance and it has been validated in accordance with the FDA’s Guidance Document Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA. This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S. C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit: Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Primary Assay)
Methodology: RT PCR (real-time reverse transcription polymerase chain reaction)
Certain mutations may affect detection of individual targets with the TaqPath™ COVID 19 High Throughput Combo Kit, including the B.1.1.7 variant of SARS CoV 2 which may exhibit positive results for the N and ORF1ab targets and negative results for the S-gene target. If such a pattern of detection is observed, further characterization of the specimen by sequence analysis should be considered. If such services are not readily available, local or state clinical laboratories should consider contacting the Centers for Disease Control and Prevention at EOCenter177@cdc.gov for additional information.
The performance of this test was established based on the evaluation of a limited number of clinical specimens. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS CoV 2 and their prevalence, which change over time. For mutations associated with specific variants that may potentially have an impact on the Amplitude™ Solution with the TaqPath™ COVID 19 High Throughput Combo Kit performance, see fda.gov/medical-devices/letters-health-care-providers/genetic-variants-sars-cov-2-maylead- false-negative-results-molecular-tests-detection-sars-cov-2.
The performance of this test was not evaluated in an asymptomatic patient population of individuals suspected of COVID 19 by their healthcare providers.
The impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated. The Amplitude™ Solution with the TaqPath™ COVID 19 High Throughput Combo Kit cannot rule out diseases caused by other bacterial or viral pathogens.
Avellino Lab USA Inc
Test Performed at: 1505 Adams Dr, Menlo Park, CA 94025
CLIA #: 05D2048075
Test Methodology & Limitations
AvellinoCoV2 test: AvellinoCoV2 Test was developed, and its performance characteristics determined by Avellino Lab USA, Inc. AvellinoCoV2 Test has been authorized by the FDA under the Emergency Use Authorization. This laboratory is regulated under CLIA as qualified to perform high-complexity testing. These tests are used for clinical purposes only. They should not be regarded as investigational or for research. A false negative result may occur if inadequate numbers of organisms are present in the specimen due to improper collection, transport or handling. RNA viruses in particular show substantial genetic variability. Although efforts were made to design RT-PCR assays to conserved regions of the viral genomes, variability resulting in mismatches between the primers and probes and the target sequences can result in diminished assay performance and possible false negative results.