SARS-CoV-2: diagnostic and design conundrums in the context of male factor infertility

Abstract

The question of whether SARS-CoV-2 (severe acute respiratory syndrome-related coronavirus-2 [SARS-CoV-2], leading to the COVID-19 infection) can be harboured in the testes and/or semen is currently unanswered. It is essential to understand the limitations of both antibody and real-time PCR tests in interpreting SARS-CoV-2 data in relation to analyses of semen and testicular tissue without appropriate controls. This article critically analyses the evidence so far on this, and the possible implications. The limitations of diagnostic tests in both sampling and testing methodologies, their validation and their relevance in interpreting data are also highlighted.

Retrospective observational RT-PCR analyses on 688 babies born to 843 SARS-CoV-2 positive mothers, placental analyses and diagnostic analyses limitations suggest vertical transmission is possible.

“…Little information existed in the validation of diagnostic tests being utilised. Numerous tests have come onto the market since these studies were reported with differing sensitivities and specificities ( Corman et al, 2020 ; Bahadur et al, 2020 ; Laureano and Riboldi, 2020 ) and its use to derive reassurances on major healthcare implication for mothers, babies and healthcare workers need caution. Single occasion screening is likely to miss potentially infected people ( Viswanathan et al, 2020 ) and clinicians should not rely on unexpected negative results and performing serial tests could overcome an individual test’s limited sensitivity.…”

“…Little information existed in the validation of diagnostic tests being utilised. Numerous tests have come onto the market since these studies were reported with differing sensitivities and specificities (Corman et al, 2020;Bahadur et al, 2020;Laureano and Riboldi, 2020) potentially infected people (Viswanathan et al, 2020) and clinicians should not rely on unexpected negative results and performing serial tests could overcome an individual test's limited sensitivity. Recent studies though not covered in our analyses are unlikely to alter the findings of this study as concerns about the lack of serial diagnostic analyses remain.…”

“…The unprecedented and exponential growth of non-peer- reviewed publications, systematic reviews lacking rigorous thoroughness and the repetitive inclusion of case reports is problematic ( Bauchner, 2020 ). We critically appraised the limitations and manner of diagnostic testing in obstetric medicine ( Bahadur et al, 2020 ). While the genetic sequence for SARS- CoV-2 became available ( Wang et al, 2020 ), it was only after mid-April 2020 that profound concerns were aired about the very high false-negative rates for antibodies.…”

“…While the genetic sequence for SARS- CoV-2 became available ( Wang et al, 2020 ), it was only after mid-April 2020 that profound concerns were aired about the very high false-negative rates for antibodies. This false-negative rate for antibodies has come down from almost 1 in 2 to 1 in 3 tests, possibly because the reverse transcription polymerase chain reaction (RT-PCR) tests were based on the previous SARS family virus ( Bahadur et al, 2020 ).…”

When Will Coronavirus Disease-19 Patients be allowed to Work at the Office Again?: A Literature Study

“…Although viral RNA can be detected by RT-PCR even after symptoms have disappeared, the amount of viral RNA detected is substantially reduced over time and is generally below the threshold for the virus' ability to replicate. Therefore, it is a safe approach to combine the time between the onset of symptoms and the disappearance of symptoms based on current data [4], [14].…”