Pooled COVID-19 Testing: A less expensive alternative to standard PCR testing
Validation
The validation data for this test falls under the regulatory scope of Clinical Laboratory Improvement Amendments (CLIA) and has not been reviewed or authorized for emergency use by the FDA. As stated by the Department of Health and Human Services, MicroGenDX is exempt from needing an emergency use authorization (EUA) because it is a CLIA-certified lab with its own lab-developed test (LDT).
MicroGenDX knows infectious disease DNA diagnostics:
- 24-48 hour turnaround time.
- Sputum/saliva test. Other specimen types also accepted. Nasopharyngeal swabs available upon request.
- More than 800,000 qPCR samples processed.
- 13 years CAP proficiency testing results showing 99 accuracy.
Who is this for?
This pooled sampling method is for large groups, particularly those with regular contact with one another. These tests are available through prepay and contract only. People who are asymptomatic should use this test. Those with symptoms should use an individual COVID-19 test.
Suggested groups include:
Schools | Offices | Sports teams | Hospitals
A Pool of Four?
Four is the number at which a single COVID-19 positive sample (at our lowest detection range for virus concentration) is not diluted by three negative samples. See more detail on our procedure below:
The MicroGenDX pooled testing approach was validated using 80 positive pools and 36 negative pools, each containing four samples previously tested individually using the COVID-19 KEY assay. A pool size of four samples was chosen based on a 10-day moving average of the current positivity rate (2.17%) of the patient population. 60% of the positive pools were within 3 Ct of the assay cutoff during initial individual testing. The shift in Ct values from original to pooled testing was observed to be 0.6 Ct. Validation of the pooled sample testing approach showed 100% agreement with the initial individual sample testing.
How does it work?
MicroGenDX will send you a box containing individualized saliva collection cups. You need to complete the included lab requisition information according to the instructions of your healthcare provider. Instructions for providing a sample are also included in the box. To collect the saliva, one person spits into one cup, creating one sample. These cups will then be sent to our lab, where MicroGenDX combines them into pools of four. The lab takes a sample from each individual collection cup in the pool and combines them into one test sample. If the pooled test sample is negative, every individual in that pool is reported out as negative, 24 hours from time of receipt. If a pooled test is positive, the four individuals in that pool will be tested again the following day as individual samples, for an additional fee. An additional, 24 hours later. Results will be reported out that day. By ordering this test, you consent to this automatic retesting and the additional charge. The end result is that every individual who provides a sample will be issued a report of virus detected or not detected.
Capacity is limited. To inquire please:
Email us at: [email protected]
Call us at: (855) 208-0019
Or fill out the form below: