FIELD OF THE INVENTION

The present invention relates to an apparatus for producing immunity certificates providing proof that a human subject is immune to a specific contagious disease, for example Covid-19. Another aspect of the invention is a method for producing immunity certificates.

BACKGROUND TO THE INVENTION

In early 2020 the world was hit by a pandemic caused by a new virus, referred to as SARS-CoV2. The disease caused by the virus is referred to as Covid-19. The virus causes a respiratory infection. In about 20% of infected patients the disease progresses to pneumonia. The disease is fatal in about 1 - 2% of the cases.

Societies are taking a variety of measures in an attempt to slow the spread of the disease, such as school closures, closures of bars, restaurants, theaters, cinemas, non-essential stores, etc. Travel, in particular international travel, has been dramatically curtailed.

These measures show signs of being effective at slowing the spread of the disease. But these measures have a tremendous cost, both social and economic. There is a growing recognition that ways must be found to gradually lift these measures. Society is facing the challenge of finding ways to gradually go back to normalcy, without causing a new wave of infections.

Individuals who have contracted Covid-19 and recovered from the disease are believed to be immune. In most cases such patients have detectable levels of specific anti-SARS-CoV2 antibodies in their blood. Many individuals are infected with the virus without developing symptoms. Yet others develop very mild symptoms that may be indistinguishable from the symptoms of a common cold or allergy. These patients are likely to have developed specific anti-SARS-CoV2 antibodies.

There is at present a scientific debate about the robustness and the duration of the immunity that these individuals have developed. But there is a consensus that, on average, an individual carrying specific anti-SARS-CoV2 antibodies are less likely to become sick after being exposed to the virus than people who do not have such antibodies.

Immunity may also result from vaccination. Several vaccines against Covid-19 have been approved, and others are being tested and prepared for approval.

As societies attempt to bounce back from Covid-19, there will be a need to reliably identify individuals who can reasonably be expected to have a certain level of immunity to the virus, which may be the result of prior infection, of vaccination, or both. Thus, there is a need for an apparatus for producing immunity certificates confirming an individual’s immunity. There is a more particular need for an apparatus that can produce immunity certificates reliably and at high speed. There is a further need for a method for producing immunity certificates.

SUMMARY OF THE INVENTION

In a first general aspect the present invention relates to an apparatus for producing an immunity certificate for a human subject, said apparatus comprising: a. a means for receiving identifying data uniquely identifying the human subject; b. a means for obtaining reliable evidence of immunity; c. a means for linking the reliable evidence of immunity to the human subject; d. a means for producing an immunity certificate based on the reliable evidence of immunity, wherein said immunity certificate contains at least part of the identifying data uniquely identifying the human subject.

In an embodiment the reliable evidence of immunity is obtained from a biological sample from the human subject, which is analyzed to determine a value of a biological parameter. On basis of the value of the biological parameter a determination is made whether the value indicates immunity for a contagious disease of interest.

Accordingly, in a first specific aspect, the present invention relates to an apparatus for producing an immunity certificate for a human subject, said apparatus comprising: a. a means for receiving a biological sample from the human subject; b. a means for receiving identifying data uniquely identifying the human subject; c. a means for producing a unique tag for linking the biological sample to the identifying data; d. a means for determining a value of a biological parameter of the biological sample; e. a means for determining whether the value of the biological parameter indicates immunity for a contagious disease; f. a means for producing an immunity certificate based on the value of the biological parameter, wherein said immunity certificate contains the identifying data uniquely identifying the human subject.

In an embodiment the reliable evidence of immunity is a determination that the human subject has received a vaccination.

Accordingly, in a second specific aspect, the present invention relates to an apparatus for producing an immunity certificate for a human subject, said apparatus comprising: a. a means for receiving identifying data uniquely identifying the human subject; b. a means for obtaining reliable evidence of immunity wherein the reliable evidence of immunity comprises reliable evidence that the human subject has been vaccinated. c. a means for linking the reliable evidence of immunity to the human subject; d. a means for producing an immunity certificate based on the reliable evidence of immunity, wherein said immunity certificate contains at least part of the identifying data uniquely identifying the human subject.

In a further aspect the present invention relates to a method for producing an immunity certificate for a human subject, said method comprising: a. obtaining identifying data uniquely identifying the human subject; b. obtaining reliable evidence of immunity; c. linking the reliable evidence of immunity to the human subject; d. producing an immunity certificate based on the reliable evidence of immunity, wherein said immunity certificate contains at least part of the identifying data uniquely identifying the human subject.

The reliable evidence of immunity may be data proving that the human subject was vaccinated.

In addition to such date or in lieu of such data the reliable evidence of immunity may be based on a value of a biological parameter.

Accordingly, in a specific aspect the present invention relates to a method for producing an immunity certificate for a human subject, said method comprising: a. obtaining identifying data uniquely identifying the human subject; b. obtaining reliable evidence of immunity comprising data proving that the human subject was vaccinated; c. linking the reliable evidence of immunity to the human subject; d. producing an immunity certificate based on the reliable evidence of immunity, wherein said immunity certificate contains at least part of the identifying data uniquely identifying the human subject.

In a further specific aspect, the present invention relates to a method for producing an immunity certificate for a human subject, said method comprising: a. obtaining a biological sample from the human subject; b. obtaining identifying data uniquely identifying the human subject; c. producing a unique tag for linking the biological sample to the identifying data; d. determining a value of a biological parameter of the biological sample; e. determining whether the value of the biological parameter indicates immunity for a contagious disease; f. producing an immunity certificate based on the value of the biological parameter, wherein said immunity certificate contains the identifying data uniquely identifying the human subject. DETAILED DESCRIPTION

A. Definitions

The term “apparatus” as used herein generally refers to a combination of the various means for producing an immunity certificate, arranged in a cooperative arrangement. All means of the apparatus may be combined in a single housing. It is also possible to provide means as individual components and using for example a computer to ensure proper cooperation of the various components. Other arrangements are also possible. For example, the means for receiving a biological sample and the means for determining a value of a biological parameter may be combined in a test kit, and the means for receiving identifying data, the means for producing a unique tag and the means for producing an immunity certificate may be combined within a properly programmed computer. The computer may be connected to a printer or some other output means, for producing the unique tag and/or for producing the immunity certificate. The immunity certificate may be produced in electronic form, and distributed by electronic means, for example by e-mail.

In case of an immunity certificate based on administration of a vaccine, the vaccine may contain a tag, such as a QCR tag or a bar code. The tag of the vaccine is linked to data identifying the subject, for example by the health care provider administering the dose of vaccine.

The term “biological sample” as used herein refers to a specimen of biological material obtained from a test subject and suitable for conducting a test aimed at determining whether the subject possesses immunity. The sample may be a tissue sample or an amount of a biological fluid. In many cases the sample is a small amount of blood, plasma, or serum.

The term “identifying data” as used herein with reference to a human subject refers to any data that may serve to identify the subject. Examples include names, date and place of birth, home address, and the like. The data must make it possible to identify the subject at the exclusion if all other human subjects, for example by containing information that is unique to the subject, such as a social security number and/or biometric data. The data may contain a picture of the subject’s face; the picture may be incorporated in the immunity certificate. Biometric data may be incorporated, for example embedded, in the immunity certificate as well.

The term “immunity certificate” as used herein generally refers to a document identifying a human subject and certifying that the subject is deemed to possess a degree of immunity to a specified contagious disease. The certificate may be protected against falsification and against unauthorized duplication. The certificate may contain embedded data for identification, for example fingerprint data identifying the human subject for whom the certificate was issued. The certificate may further contain data pertaining to date, time and place of its creation and the identity of the person who operated the apparatus when the certificate was created, to allow tracing and to facilitate fraud detection. In case the immunity is based on reliable evidence of vaccination the immunity certificate may be referred to as a vaccination certificate or a vaccination passport.

The term “unique tag” or “tag” as used herein refers to any type of label suitable for linking the biological sample to the human subject. A familiar example is a set of self-adhesive labels bearing a code, such as a barcode. One label is affixed to a vessel, for example a vial or a pipette, containing the biological sample. Another label is affixed to a physical embodiment of the identifying data of the human subject, for example a completed form or a printout. To avoid or at least minimize the risk of human error it is preferred to use electronic tags. For example, fingerprint data from the human subject, such as a Touch ID profile, may be read into an RFID chip affixed to a container holding the biological sample as a way of linking the sample to the identifying data of the human subject.

The term “value of a biological parameter” as used herein refers to any parameter that may serve to determine whether a subject possesses immunity. In many cases the parameter is the presence or absence of antibodies that specifically bind to a pathogen that causes a contagious disease. The “value” may be qualitative (i.e., the presence or absence of a pathogen-specific antibody), quantitative (a measure of the amount of pathogen-specific antibody in the sample), or semi-quantitative (for example a relative amount in comparison with a standard).

B. Apparatus

It is as yet unclear how different societies will be using immunity certificates in their management of the Covid-19 outbreak. There is a tension between, on one hand, the need of society to restart activities in a responsible manner, and on the other hand concerns about privacy and discrimination. Different societies will find different ways of resolving this tension. There will in any event be a need for maximizing the reliability of the immunity certificate. The apparatus of the present invention provides a number of safeguards aimed at maximizing the reliability of the immune certificate produced by the apparatus.

There are three main sources of potential lack of reliability of an immunity certificate: (i) errors of the underlying test method or failure of a vaccine to provide immunity; (ii) identification errors; and (iii) dishonesty.

As to (i), no method is 100% reliable. Any biological test may produce false positives and false negatives. For the reliability of the resulting immune certificates, false negatives are not an issue. But they do present a cost to society, and steps must be taken to minimize them. This is outside the scope of the present invention. False positives directly affect the reliability of immune certificates and must be reduced to the achievable minimum. This is outside the scope of the present invention.

The reliability of the test method may also be affected by the skill and ability of the operator of the apparatus. Operator errors are far more likely to result in false negatives than in false positives, and for this reason are not a major threat to the reliability of the immune certificates. Nevertheless, it is important to reduce operator errors. As a general rule this can be accomplished by automating as many as possible of the individual operating steps (introduction of the biological sample into the apparatus, introduction and dosing of reagent(s), timing of the readout, interpretation of the readout, etc.). In an embodiment manipulation of the biological sample and the reagent or reagents are partially automated. In a preferred embodiment manipulation of the biological sample and the reagent or reagents are fully automated.

A vaccine may not provide full immunity in a particular human subject. It is recognized that a vaccination certificate or vaccination passport does not guarantee immunity.

A vaccine may require multiple administrations, for example two administrations, to achieve an acceptable probability of immunity. Therefor the apparatus may store data pertaining to a first administration of a vaccine to a human subject, and only produce an immunity certificate upon administration of a subsequent dose.

Identification errors are a concern in any type of medical intervention or clinical testing, and medical providers, clinical labs and their suppliers have developed sophisticated systems to avoid human error as much as possible. The test subject must provide identification data uniquely identifying the subject. Such data may include, for example, the subject’s name, date of birth, and social security number. The subject must provide evidence of such credentials, for example by providing a driver’s license, a passport, or other government issued photo id.

In an embodiment of the invention the subject provides a form of biometric data for identification. Examples of biometric data include an iris scan and a fingerprint. In an embodiment the immune certificate is electronically linked to a biometric data of the subject. For example, as part of the identification process the subject presenting the biological sample at the same time provides a fingerprint. Technology such as Apple’s Touch ID may be used for this purpose. If the subject’s biological sample produces a result indicating immunity, the apparatus produces an immune certificate. In this example the certificate may be in electronic form and may be sent to the subject’s e- mail address. The subject may make the certificate visible on the screen of an iPhone or iPad by producing the fingerprint that is embedded in the certificate. This ensures that only the person who produced the biological sample is able to produce the certificate for inspection. Use of a biometric tag makes it possible to use Internet communication in producing the immunity certificate. For example, the subject orders a test kit and has it delivered at home. The test kit comprises a sample taking unit that is to be placed over the tip of one of the subject’s fingers. The subject starts the procedure by connecting to a website that is set up for this purpose. The subject then places the sample taking unit over the tip of the finger from which a blood sample is to be taken. The sample taking unit makes a scan of the print of the finger, then pierces the finger, and withdraws a drop of blood. To prevent fraud the subject’s finger may not be removed from the sample taking unit until after the drop of blood has been removed. In this manner the biological sample is inextricably linked to the fingerprint data.

The apparatus comprises a means for receiving a biological sample from the human subject. This term encompasses various components as may be required to obtain the sample from the subject, and to transfer the sample from the subject to a component of the apparatus in which the test will be carried out. In the case of a blood sample, for example, the means comprises a sharp tool for pricking a finger of the subject, and a pipette for siphoning up a drop of the subject’s blood and for depositing the blood into a recipient, for example a well of a cassette, where the actual test will be carried out.

The apparatus comprises a means for receiving identifying data. Examples include a keyboard used for entering data into a computer, a machine reader for reading information from a digital ID card or passport, and the like. In a preferred embodiment the means comprises a device for acquiring biometric data from a subject, such as an iris scanner or a fingerprint reader. The means may make use of the Touch ID feature of an iPhone or other Apple® device.

The means for producing a unique tag provides a crucial aspect of the apparatus, because correctly and inextricably linking the sample to the identifying data is essential for the integrity of the immunity certificate produced by the apparatus. Clinical labs have developed protocols for achieving this.

These protocols often comprise use of self-adhesive barcodes that are affixed to specimen vials and paperwork belonging to the same test. In order to minimize the risk of human error and to increase the speed of the testing, it is preferable to make use of electronic tags. For example, a computer that is used for entering the subject’s identifying data may produce a unique code, which is read into an electronic tag, such as an RFID tag, affixed to a recipient holding the sample. In a further preferred embodiment, the tag comprises biometric data of the subject.

The means for determining a value of a biological parameter may be any biological assay capable of determining an indicium of immunity. For example, the assay may test for the presence of antibodies that specifically bind to a pathogen. The assay may use any type of antibody determination technology, such as lateral flow, ELISA, and the like. It is possible to test simultaneously for the presence of different isotypes of antibody. For example, the presence of IgM antibodies may point to a recent infection The presence of IgG in addition to IgM indicates that some isotype class switching may have taken place, consistent with a somewhat longer period of time between the onset of the infection and the test. It is also possible that only IgG isotype antibodies are found. Depending on the specific test it may be prudent to only conclude the presence of immunity only if IgG isotype antibodies are present. If IgM antibodies are detected, and IgG antibodies are not, the test may be repeated at a later point in time to determine whether immunity has been fully established.

In an embodiment the assay contains a positive control, which provides confirmation that the assay was conducted properly. Use if a positive control significantly reduces falsely negative test results.

Depending on the specific assay, the test result may be presented in the form of visible lines on an absorbent substrate, a colour change, the presence or absence of a circle, etc. The test result may be read by a human operator and entered into a computer. Preferably the test result is read electronically, for example by scanning a visual indicium on a testing cassette and comparing the result with reference patterns stored in the computer’s memory.

The means for determining whether the value of the biological parameter indicates immunity for a contagious disease may take the form of a comparison of the output of the assay with a reference. This may be done by a trained human operator, in which case the human operator briefly becomes part of the apparatus. Preferably, the comparison is done electronically. It is desirable to bias the comparison so as to avoid false positives, even though doing so may increase the occurrence of false negatives, because false positives are far more harmful than false negatives. Machine learning and artificial intelligence can be used to improve the performance of the comparison, so that the occurrence of misdiagnoses decreases.

A positive test results triggers the creation of a certificate of immunity. The certificate confirms that the tested human subject possesses immunity to the specific contagious disease. The certificate also contains the identifying data uniquely identifying the human subject. The certificate may be produced in hard copy form, or in electronic form, for example. If in hard copy form, the document may be protected against unauthorized copying. The document may comprise a picture of the subject’s face. Preferably the certificate is in electronic form. It may contain biometric data of the subject. The electronic document may be protected so that only the subject is able to open it, using biometric data, such as a finger print or iris scan.

C. Auditable traces

Although the apparatus contains various safeguards against fraud, it must be recognized that it is virtually impossible to completely prevent fraudulent activity. For this reason it is important to provide means for determining fraud after the fact, and traceability so that the perpetrator of a fraud may be identified. The government may impose severe criminal sanctions for such fraud, so as to provide a powerful deterrent. In an embodiment the biological samples are collected and stored after the test has been conducted. Law enforcement agents may randomly test DNA samples of holders of certificates. The results can be compared with the retained sample of the certificate holder. This provides a check as to whether the biological sample was provided by the certificate holder.

In an alternate embodiment the test apparatus creates a DNA “fingerprint” of the biological sample. The DNA fingerprint may be incorporated in the certificate, and used for random checks.

In an embodiment details of the operator of the apparatus are contained in the certificate. This allows for the operator to be investigated by law enforcement if the certificate is later found to be fraudulent.

D. Operation of the apparatus

In an embodiment the apparatus is operated by a licensed professional. The apparatus may be located at a clinical lab, a walk-in clinic, a pharmacy, etc.

In another embodiment the apparatus has the form of a user-operated kiosk. The user may scan a passport for identification, Identification may be supplemented with a fingerprint scan, for example. Kiosks may be placed at airports, for example. Travelers may be required to submit to a test prior to boarding an international flight, or upon arrival from an overseas departure point. Security personnel may be employed to make sure that not more than one person is at a kiosk at any time. This prevents fraud in the form of having a fellow-traveler provide the biological sample.

In an embodiment the test is conducted remotely, for example at a subject’s home. The subject obtains a test kit, which comprises a cassette with a clearly visible identification code. The subject conducts the test, and takes a picture of the cassette showing the result and the identification code. The subject uploads the picture to a website, which issues an immunity certificate. This embodiment requires specific safeguards against sample switching.

E. Contagious diseases

Although this invention specifically addresses a need created by the advent of Covid-19, the apparatus and method of this invention can be used in slowing or preventing the spread of any contagious disease. The disease may by caused by any pathogen, for example a bacterium, a virus, a fungus, or a parasite.

In an embodiment the contagious disease is caused by a virus, for example a corona virus. In an embodiment the virus is SARS-CoV2.