COVID-19 Test Overview
The Color SARS-CoV-2 amplification test is a loop-mediated isothermal amplification (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 amplification test 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 Amplification 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.
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.
- 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
- More than 48 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, a high throughput, LAMP-based assay, was performed at Color, CLIA #05D2081492, CAP #8975161. This test is not FDA-cleared but its performance characteristics were established by a CLIA-certified high-complexity laboratory in accordance with CLIA regulations. The test was validated on 37 positive and 502 negative specimens representing nasopharyngeal (NP) and oropharyngeal (OP) swabs and found to have 100% accuracy with a lower limit of detection of 0.75 copies/µl in the primary sample.
- Test Limitations include
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- If the virus mutates in the target region, SARS-CoV-2 may not be detected or may be detected less predictably.
- The test was validated for use with upper respiratory specimens collected in DNA/RNA shield, VTM,UTM, or tubes without media. The performance of this test has not been established for other specimens. Specimens collected using other FDA recommended Specimen Collection Materials listed in the FDA Guidance of March 16, 2020 are processed with the caveat that they were not all validated for use with this test and the result must be interpreted in this context. Furthermore, a false negative result may occur if a specimen is improperly collected, transported or handled.
- False negative results may also occur if amplification inhibitors are present in the specimen or if inadequate numbers of organisms are present in the specimen. Optimum specimen types and timing for peak viral levels during infections caused by SARS-CoV-2 have not been fully determined. Collection of multiple specimens (types and time points) from the same patient may be necessary to detect the virus.
- In some cases, samples may be processed using the CDC 2019-nCoV Realtime RT-PCR test, performed by the Clinical Research Sequencing Platform at the Broad Institute of MIT and Harvard, 320 Charles Street, Cambridge, MA 02141, CLIA #22D2055652, CAP #8707596. If this is the case, this will be indicated on the result report. Further details about this assay can be found here and here.