The COVID-19 pandemic has triggered an unprecedented demand for diagnostic tests. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is highly contagious in the presymptomatic period, when the viral load is high. In the effort to reduce transmission, for the first time in infection diagnostics history, testing is being aimed not only at symptomatic, but also at asymptomatic individuals, both in the health care setting and in the community.Shortages in PCR reagents and platforms, related to the demand for large-scale testing, fuelled the effort for alternative diagnostic solutions. We have read with interest the Journal of Infection (JoI) article, regarding the laboratory based assay chosen by the British government, for SARS-CoV-2 mass testing (Operation Moonshot), a loop mediated isothermal amplification (LAMP), produced by OptiGene. 1 , 2 The testing of saliva by OptiGene direct ORF1ab LAMP (with no RNA extraction), in newly built laboratories under the management of acute NHS Trusts, is costing the taxpayer over 400 million British pounds and has resulted in the movement of key staff away from essential roles in acute NHS Trust diagnostic laboratories, at short notice.The OptiGene assay on saliva samples is intended for the testing of asymptomatic NHS staff, to help prevent hospital acquired outbreaks. The assay however, failed to detect more than 50% of saliva positive cases in a pilot in Greater Manchester, when compared to a "gold standard" qPCR (polymerase chain reaction) assay. 2 In contrast, recently published data from the Department of Health and Social Care (DHSC) report 70% sensitivity for swabs and 79% for saliva for this assay. 2 To understand the performance in more detail, 86 PCR positive nose and throat swabs, with a variable viral load, collected from patients and symptomatic or asymptomatic members of hospital staff, were tested in parallel by direct LAMP and in-house CDC N1/N2 qPCR (Limit of Detection (LOD) 156 digital copies/mL or 2 • 6 digital copies per reaction, Qnostics) at the Southampton Specialist Virology Centre. These samples were stored at 4 °C, prior to being frozen at −80 °C within 36 h of sample collection. The SARS-CoV-2 Molecular Q Panel (SCV2MQP) from Qnostics was used to quantify the qPCR results in digital copies/mL.Consistent with results from the Manchester Regional Virus Laboratory, which evaluated freshly collected saliva samples from asymptomatic individuals, we have been unable to replicate the sensitivity (see Table 1 ) reported by the DHSC. For this reason, we would like to raise a number of points on which we seek clarity.A sample of > 10,0 0 0,0 0 0 ( > 10 7 ) digital copies/mL (dc/mL), collected from a symptomatic NHS staff member, swabbed on day one of symptoms, produced a negative result when tested by the OptiGene direct LAMP method. Similarly, a swab from an asymptomatic staff member, a target group for this assay, with 2,50 0,0 0 0 (2.5 × 10 6 ) dc/mL was missed. A false negative result, with a high viral load, is a patient safety risk, particul...