'Failure rate leading to false-negatives and repeat testing' - MDCG and Common Tech Specs

#1
Can anyone help me understand this sentence please:

"as part of the required risk analysis the whole system failure rate leading to false-negative results shall be determined in repeat assays on low-positive specimens."

It appears in MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices and also COMMISSION DECISION of 27 November 2009.
CE marking of the SARS-CoV-2 device I am working on will be comply to ISO 14971 for risk assessment plus IVDR risk management but this particular sentence is in relaiton to performance testing. I can't work out if maybe means something like whats pulled out of the risk analysis should dictate the performance testing design or something else?
 
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