- By Dina Temple-Raston / NPR
May 22, 2021 | 8:15 AM
(Washington): A defective coronavirus test distributed by government scientists in the early days of the pandemic was poorly designed and presented erroneous instructions that made it doubly difficult for laboratories to rely on test results, according to new records. Deficiencies in test kits cost the nation precious weeks as officials tried to detect virus hot spots and control the outbreak.
The new details can be found in an internal report from the Centers for Disease Control and Prevention that explores why the agency’s original coronavirus testing kit failed. Some of the initial tests sent to the nation’s labs in February 2020 delivered “inconclusive” readings, further delaying the nation’s ability to identify COVID-19 cases. The kits were developed so that states could conduct their own tests and obtain test results faster than sending samples to the Atlanta CDC.
NPR obtained a copy of the report after suing the CDC under the Freedom of Information Act. The initial review, known as “root cause analysis,” was conducted by the agency in March 2020 to determine why an initial coronavirus test did not work properly. The review was updated in October with new details of what the investigation found.
According to the report, the fundamental problem of the evidence was “inadequate documentary control.” What this means is that there were several versions of instructions and protocols circulating in the lab that developed the test kits, so there was an inconsistency in how they were performed. “In particular, the absence or ineffectiveness of good document control resulted in the application of several different versions of quality control (QC) procedures,” the report said.
The review explains NPR reports in November that revealed that a small CDC infectious disease lab knew the coronavirus testing kit it had developed could fail 33% of the time, but published it anyway. Under normal circumstances, this type of failure would stop a test in its tracks.
The October report also indicates that in addition to ignoring the test could fail a third of the time, the instructions the nation’s public laboratories were supposed to follow to replicate the test in their own labs were problematic.
A graph in the report shows that the concentrations of various chemicals used in the construction of the test were inconsistent. And while the differences reported in a table in the report are small enough that they don’t necessarily affect the overall performance of the test, lab officials told NPR that they are an indication of a more fundamental problem. : obsolete procedures for conducting tests floated the laboratory.
The inconsistency exposed in the report is very similar to using a little less flour in a cake recipe, except that in this case it was part of a very sensitive test. “If you have different copies of the recipe, make slightly different versions of the protocol, and that’s not what we want,” said a lab official who had seen the table in the report.