A field testing lab set up at Harding Community College, 1645 7th Ave SE, run by an organization called BioCorpoZon, located at 3400 S. Lulu Ave, St. Paul, Dakota County, Minnesota 55124
A Covid-19 Molecular test was requested by a patient whose name was Taylor Chayton. She lives at 452 E. Cochise Ave in St. Paul, Zip Code 55124. Her appointment was set at 3:30PM on August 19, 2020. It took 20 minutes to process her paperwork before the sampling occurred.
A swab was used to collect a nasopharyngeal (NP) specimen. This swab was produced by Puritan Medical Products in Guilford Maine located at 31 School St., Zip Code 04443 ( SKU#: 25-3320-U EMB 80MM it had a Lot # of 053928-A ) The swab containing the sample material from the rear of the patient’s nasal cavity was placed in a UTM Tube (part # 331C) produced by Copan Diagnostics, 26055 Jefferson Ave, Murietta CA, 92562. The lot number of the tubes used was 0045-2093-37. The sample’s paperwork had a pre-printed SNOWMED code on it of 840533007 (indicating the presence of SARS-CoV-2)
It was collected and stored as per LabCorp published Guidelines
The UTM Tube containing the swab was placed in a freezer on-site by a Nurse Practioner, the same person who performed the test, named Annabelle Ling. She recorded the time the sample was placed in the freezer as 4:05pm. The freezer temperature recorded was -18 deg C. The sample’s was picked up at at 7:10 PM by a field sampling driver named Howard DeClerc. He placed it in his van’s freezer compartment at 7:20. The temperature of the freezer compartment was recorded to be -12 C at that time. He drove it to a local LabCorp facility located at 402 County Rd. D West, St. Paul, MN 55112, and signed off on it at 8:55pm. The sample was logged in by a person, Nancy Windstead, working at the front desk. At 9:02pm It was assigned a LIMS generated lab control number of 08192203. The sample container was labeled 08192203-A. Ms. Windstead used a batch entry macro that simultaneously requested test 139900–Covid019 to be performed on that sample. She took an image with a lab assigned cell phone and uploaded the image into her LIMS at 9:27pm. She put the sample container in a storage freezer, labeled F-29UC, at the facility at 9:31pm. She did not make note of the freezer temperature.
The next morning, at 10:45am of August 20th, a level 4 medical technician named Donnie Blum took possession of the sample from the freezer F-29UC and immediately tested the sample using PCR cycling. The LOINC Code for the test being performed was 94500-6. He followed the FDA EUA methodology here:
He failed to detect the target RNA sequences N1, N2 and N3 after RNA amplification and fluorescent marker spectroscopy. The device he used to obtain the result was an Applied Biosystems QuantStudio(TM) 5 Real Time PCR instrument. The lab has 14 of these test devices and this particular one the test was performed on is uniquely called, by that laboratory’s technicians, “Baldur” after a Norse mythological character. He obtained the result at 2:30pm the same day. He logged the result into the LIMS system manually as “NEG”. As the sample was entirely consumed by the test, there was nothing left to store afterwards so the swab and UTM container were disposed of.
On the report generated by the LIMS system, delivered back to the clinical pathologists at BioCorpoZon, the Negative test result for the sample was communicated labeled “SARS-CoV-2” and had an accompanying LOINC Result Code of 139975.