As the pandemic has struck the predicted second wave, public struggles persist with lifestyle restrictions, but our knowledge to identify and fight the virus has significantly progressed.

With tests developed, distributed and administered satisfactorily for most symptomatic sufferers (PCR), and the vaccine roll out for the most vulnerable, science and medicine turn to consider the silent carriers of SARS-CoV-2…the asymptomatic vectors.

The case for rapid antigen testing using Lateral Flow

At present testing generally consists of Polymerase Chain Reaction (PCR ) or Lateral Flow Tests (LFT) also known as rapid or antigen tests. Writing on these previously highlighted the differences and nuances of each. Regarding asymptomatic carriers it would appear that PCR will test positive for a longer period of the infection, even if the individual is not contagious. It can also take a long time to get PCR test results, often days – making them non-suitable for detecting asymptomatic carriers in everyday social settings such as schools. Lateral flow tests are considerably quicker, providing a result in 10-30 minutes, and significantly cheaper as they do not require a laboratory.

Graph – High-Frequency Testing with Low Analytic Sensitivity versus Low-Frequency Testing with High Analytic Sensitivity

Analysis of UK mass lateral flow test events have been beneficial. It is suggested the 60% of people who had “false negative” tests in the Liverpool pilot were not contagious. As the graph shows, PCR sensitivity may be detrimental when considering the effects of extreme and unnecessary self-isolation requirements. Evaluations have shown that lateral flow tests identify 90100% of asymptomatic individuals whose samples go on to provide viable virus in cultured samples. 

Results from an American University mass testing event showed the ability to culture viable virus from a sample means the virus is capable of reinfecting, hence the individual is contagious. This study also used lateral flow tests and showed similar results to the UK. Virus samples collected were able to infect cell cultures in vitro, showing their viability. Good news indeed for identifying individuals who are asymptomatic and infectious.

Repeat testing using lateral flow tests, especially in high transition groups, medical staff, teachers and carers, with a short turn around time, will help reduce transmissions. The cost effectiveness and ease of a lateral flow test makes repeat testing an obvious option.  

Not to rapid test

Evidence from mass testing events (previous blog) has suggested lateral flow tests can miss up to approximately 60% of infected people. In the UK Liverpool study a third of people tested negative even with high viral loads, implying the individuals would be infectious, even if they were asymptomatic. A negative lateral flow test would potentially release this individual into the population to spread the disease, although this assumes positive individuals ignore the guidance to not treat a negative result as a definitive confirmation of COVID-negative status. This scenario shows how important other preventative measures are, such as social distancing and hand washing. Unfortunately Liverpool, whilst providing reams of data, is also, to date (18th Jan 2021), one of the few UK areas with increased cases of the disease, even after all the lockdown measures and mass testing. 

France has recently voiced its concerns over lateral flow tests and have insisted that any non-EU travellers must have a negative RT-PCR test; they will no longer accept a negative lateral flow test as sufficient for entry into France. This will inevitably feed into the public concern over lateral flow test results and cause many issues, not only because at present, certainly in the UK, you only qualify for an RT-PCR test if you are symptomatic. Medicines and Healthcare products Regulatory Agency (MHRA) have raised concerns about using lateral flow tests in UK schools as there is no ‘test-to-enable’, this had led to a pause on testing in UK schools. A test-to-enable would provide definitive results as to the infectiousness of an individual.

Mass testing has been touted as the way out of the crisis since it began. Now we are getting into a position to test everyone how might this affect human behaviour? People are encouraged to act as if they are positive for COVID-19, but the increase in testing means many will have a “negative” test and could decide to ignore social distancing guidance on the basis of it. This had been flagged as a major (hypothetical) problem by some highly-credentialed scientists taking issue with the UK’s lateral flow test testing program.

Most tests need a swab of some kind to collect their sample, exceptions being drooled saliva and blood samples. Sample collection can be uncomfortable but most willingly go through the procedure. Often sample collection is supervised with the individual taking the actual sample. This has implications for correct procedure sample collection, with reports from the Liverpool mass testing suggesting the test performed worse when civilians performed their own test without supervision. For others, who are unwilling or unable to undergo the stress or complexities of testing, the test may fail from the start with inadequate sample collection. As yet lateral flow tests are not readily available without symptoms at home.

Logical Biological’s View

Our view is that lateral flow tests are a cheap and easy test that when performed on a regular basis in certain settings, schools being a prime example, can identify a substantial proportion of infectious individuals, enabling them to be removed quickly from that setting. This would undoubtedly improve the safety of those associating with them in the same setting, allowing the setting to remain open for longer, to the benefit of society. However, in order to maximise the utility of such an approach a minimum test frequency guideline should be defined in each setting. This testing should be frequent, ideally daily.  

Other high risk settings are likely to include meat processing plants, university halls of residence and care homes (staff and visitors). Imagine how much safer you would be as a teacher, parent or care home resident if most asymptomatic people you or your loved ones associated with were identified and self-isolated. This would also cut chains of transmission and reduce strain on health systems. For these reasons many scientists have pushed back against the warnings from researchers with ‘unfounded criticism’ of the lateral flow test.

Currently no test can definitively assess for SARS-CoV-2 infectiousness, and to attain that ideal may take many months/years or may never happen. Heeding the prescient words of Mike Ryan at the outset of the pandemic “perfection is the enemy of the good. Speed trumps perfection”, we are frustrated at resistance from within the scientific community to the use of technologies that, despite their imperfections, are likely to have an enormous benefit to society. 

Logical Biological Products

At Logical Biological we supply nasopharyngeal/oropharyngeal/nasal SARS-CoV-2, FluA and Flu B swabs available in UTM, Inactivating TM, saline or dry frozen. Negative swabs and COVID-19 / pre-COVID saliva are also available. Typically, our swabs are provided together a Ct value measured from a ‘companion swab’ taken simultaneously. We also provide serum and plasma samples from individuals infected with SARS-CoV-2 and other respiratory infectious diseases. Samples from vaccinated individuals can be collected.

Table: Products available from Logical Biological

We are in the midst of the most significant global pandemic since the 1918-19 Influenza pandemic, over 100 years ago. The 2020 pandemic has been caused by a Coronavirus, named SARS-CoV-2, which confers a severe respiratory illness (COVID-19) on a proportion of those infected. The virus is readily transmissible from human to human with many of those infected showing no or mild symptoms, meaning it is hard to know who has been infected.

The virus has resulted in severe economic impacts because many countries have adopted “lockdown” policies in order to limit its spread by limiting interaction between individuals. One idea for mitigating some of the economic impact has been to identify and liberate from lockdown those individuals who have already been infected by the virus and may therefore be immune from future infections. As yet, it is not known for sure if previous infection by the virus renders individuals immune from future viral challenge, nor how long such immunity would last for. However, for this idea to be viable, diagnostic tests that can identify the SARS-CoV-2 antibodies in the human blood are required. Such tests have been made by innumerable manufacturers but they vary greatly in their performance.


At what stage are antibodies exhibited?

To understand the value of SARS-CoV-2 antibody tests we need to know who exhibits what antibodies, and when. It is assumed that the vast majority of individuals will have a detectable antibody response, regardless of whether or not they are symptomatic. The below data suggests IgG and IgM antibodies are detectable 1-3 weeks after SARS-CoV-2 symptom onset.

Detection of IgG, IgM and Neutralising (NT) antibodies over time since symptom onset.
Taken from a pre-print published online by Borremans et al., (2020)


Why 100% test specificity is essential for SARS-CoV-2

Logical Biological received some CE-marked SARS-CoV-2 IgG and IgM antibody tests a few weeks ago (we won’t name the manufacturer). In the pack insert these tests reported 97% specificity, which sounds high, but what does it mean in the context of the proportion of people who actually have been infected in the population? Specificity can be defined as the number of true negative cases that actually return a negative test result.

As can be seen in the tables below, if 1 person is selected at random and tests positive using a 97% specificity test when the prevalence within the population is low, it is much more likely that a positive test result is a false positive than a true positive.

Even with a 99.6% specificity test, such as those now available in a leading UK high street pharmacist, there is a clear threat of false positives, the proportion of false positives to actual positives reducing as the true number of infected within the population increases. One serology study, performed in Santa Clara, California, received criticism that the specificity of the test was too low, at only 99.5%. Only with 100% can we be fully confident that the positive test result is a true positive. Fortunately, such tests are now becoming available, such as one developed by Ortho Clinical Diagnostics.

The tables below consider a random selection of the population. Individuals may feel more confident about a positive result they receive if they have also shown the classical symptoms.

97% Specificity

% of population prev. infected Test Specificity True positives (per 1000) Expected False positives (per 1000)
0.1% 97.0% 1 30
1% 97.0% 10 30
10% 97.0% 100 30
100% 97.0% 1000 30


99.6% Specificity

% of population prev. infected Test Specificity True positives (per 1000) Expected False positives (per 1000)
0.1% 99.6% 1 4
1% 99.6% 10 4
10% 99.6% 100 4
100% 99.6% 1000 4


100% Specificity

% of population prev. infected Test Specificity True positives (per 1000) Expected False positives (per 1000)
0.1% 100.0% 1 0
1% 100.0% 10 0
10% 100.0% 100 0
100% 100.0% 1000 0



Sensitivity of a test can be defined as the proportion of those genuinely bearing a marker (such as SARS-CoV-2 antibodies) who test positive for it. In the context of SARS-CoV-2 antibody tests, results from low sensitivity tests are less “dangerous” than results from low specificity tests. Low specificity tests could result in a situation where susceptible individuals who have wrongly tested positive, believing themselves to be both immune and non-infective, stop taking precautions to protect themselves and others, leading to further infections. On the other hand, low sensitivity tests would likely result in previously-infected individuals who have wrongly tested negative continuing to be cautious and since they have already had the infection would not be able to contribute to further spread in any case.

Table shows theoretical results of a 97% sensitivity test

% of population prev. infected Test sensitivity True positives (per 1000) Expected positives based on 97% sensitivity
0.1% 97.0% 1 0.97
1% 97.0% 10 9.7
10% 97.0% 100 97
100% 97.0% 1000 970



How many people have actually been infected by SARS-CoV-2?

One of the countries most affected by the pandemic has been Spain. The government of Spain has recently performed a serological study (results published on 13th May 2020) where they assessed the blood of 70,000 individuals. The most affected province showed 14.2% positive tests whereas the least affected regions were at less than 2%. The overall figure for previously-infected individuals in Spain was assessed to be approximately 5%. The test looked for both IgG and IgM antibodies. In the context of the above information, it should be noted that the test used was reported to show 100% specificity and 79% sensitivity for IgG. This means it would miss 21% of those previously infected and also may miss some people in the early stages of infection. It was wise of them to choose a 100% specificity test, and in the context of a serological survey to assess prevalence within a large population, the results can be adjusted to account for the low sensitivity of the test.

Data from other countries is in line with that from the Spanish study. For example, study results announced on April 23rd from another of the world’s major hotspots, New York State, USA, found 21% of people to be antibody positive in New York City. High figures (10-20%) were also seen in other areas while outside of the most-affected areas in the state the average prevalence was 3.6%.



The prevalence of SARS-CoV-2 in some locales is 2-20%. At the upper end of this range the % of positive tests that would be false when using a 97% specificity test would be significant and unacceptably high. At the low end of this range there would be more false positives returned than true positives, rendering such a test completely useless. Beware SARS-CoV-2 antibody tests with <100% specificity.


Available from Logical Biological

  • SARS-CoV-2 PCR positive serum/plasma/swabs
  • SARS-CoV-2 IgG positive serum/plasma – 1ml samples and bulk units
  • SARS-CoV-2 IgM positive serum/plasma – 1ml samples and bulk units
  • Pre-Covid19 serum/plasma from normal healthy donors – any quantity

Due to the dynamic nature of the SARS-CoV-2 pandemic this blog post will be out of date shortly after it is written.