Diagnostic Immunology
Immunoassays for Disease
Immunoassays are laboratory techniques based on the detection of antibody production in response to foreign antigens.Learning Objectives
Describe how immunoassays aid in the diagnosis of diseaseKey Takeaways
Key Points
- When microbial agents penetrate the body, they elicit an immune response that involves cellular and humoral components.
- An immune response is usually characterized by antibody secretions. These can be measured in the laboratory through various biochemical and serological techniques.
- Most immunoassays rely on the formation of antibody- antigen complexes that can be identified using an indicator molecule.
Key Terms
- humoral: Of or relating to the body fluids or humours.
- antibody: A protein produced by B-lymphocytes that binds to a specific antigen.
The Immune System
Immunology is the study of molecules, cells, and organs that make up the immune system. The function of the immune system is to recognize self antigens from non-self antigens and defend the body against non-self (foreign) agents. Through specific and non-specific defense mechanisms, the body's immune system is able to react to microbial pathogens and protect against disease. The first line of defense against infection is intact skin, mucosal membrane surfaces, and secretions that prevent pathogens from penetrating into the body.When a foreign agent penetrates the first line of resistance, an immune reaction is elicited and immune cells are recruited into the site of infection to clear microorganisms and damaged cells by phagocytosis. If the inflammation remains aggravated, antibody-mediated immune reaction is activated and different types of immune cells are engaged to resolve the disease. The immune system is composed of cellular and humoral elements. The cellular component includes mast cells, neutrophils, macrophages, T and B lymphocytes, and plasma cells. The humoral component includes complement, lyzozyme, interferon, antibodies, and cytokines. All work cooperatively to eliminate immunogenic foreign substances from the body.
Immune complex: This is the complex formation of a specific antibody-antigen.
Immunoassays
To aid in the diagnosis of disease caused by infectious microorganisms, immunoassays have been developed. These biochemical and serological techniques are based on the detection and quantitation of antibodies generated against an infectious agent, a microbe, or non-microbial antigen.Because antibodies can be produced against any type of macromolecule, antibody-based techniques are useful in identifying molecules in solution or in cells. A blood sample is collected from the patient during the acute phase of the disease when antibody levels are high. Serum is then isolated and the concentration of antibodies is measured through various methods. Most assays rely on the formation of large immune complexes when an antibody binds to a specific antigen which can be detected in solution or in gels. Recent methods employ pure antibodies or antigens that have been immobilized on a platform and that can be measured using an indicator molecule. These methods provide high sensitivity and specificity and have become standard techniques in diagnostic immunology.
Antibody Functions
Antibodies, part of the humoral immune response, are involved in pathogen detection and neutralization.Learning Objectives
Differentiate among affinity, avidity, and cross-reactivity in antibodiesKey Takeaways
Key Points
- Antibodies are produced by plasma cells, but, once secreted, can act independently against extracellular pathogen and toxins.
- Antibodies bind to specific antigens on pathogens; this binding can inhibit pathogen infectivity by blocking key extracellular sites, such as receptors involved in host cell entry.
- Antibodies can also induce the innate immune response to destroy a pathogen, by activating phagocytes such as macrophages or neutrophils, which are attracted to antibody-bound cells.
- Affinity describes how strongly a single antibody binds a given antigen, while avidity describes the binding of a multimeric antibody to multiple antigens.
- A multimeric antibody may have individual arms with low affinity, but have high overall avidity due to synergistic effects between binding sites.
- Cross reactivity occurs when an antibody binds to a different-but-similar antigen than the one for which it was raised; this can increase pathogen resistance or result in an autoimmune reaction.
Key Terms
- avidity: the measure of the synergism of the strength individual interactions between proteins
- affinity: the attraction between an antibody and an antigen
Antibody Functions
Differentiated plasma cells are crucial players in the humoral immunity response. The antibodies they secrete are particularly significant against extracellular pathogens and toxins. Once secreted, antibodies circulate freely and act independently of plasma cells. Sometimes, antibodies can be transferred from one individual to another. For instance, a person who has recently produced a successful immune response against a particular disease agent can donate blood to a non-immune recipient, confering temporary immunity through antibodies in the donor's blood serum. This phenomenon, called passive immunity, also occurs naturally during breastfeeding, which makes breastfed infants highly resistant to infections during the first few months of life.Antibodies coat extracellular pathogens and neutralize them by blocking key sites on the pathogen that enhance their infectivity, such as receptors that "dock" pathogens on host cells. Antibody neutralization can prevent pathogens from entering and infecting host cells, as opposed to the cytotoxic T-cell-mediated approach of killing cells that are already infected to prevent progression of an established infection. The neutralized antibody-coated pathogens can then be filtered by the spleen and eliminated in urine or feces.
Mechanisms of antibody action: Antibodies may inhibit infection by (a) preventing the antigen from binding to its target, (b) tagging a pathogen for destruction by macrophages or neutrophils, or (c) activating the complement cascade.
Affinity, avidity, and cross reactivity
Not all antibodies bind with the same strength, specificity, and stability. In fact, antibodies exhibit different affinities (attraction) depending on the molecular complementarity between antigen and antibody molecules. An antibody with a higher affinity for a particular antigen would bind more strongly and stably. It would be expected to present a more challenging defense against the pathogen corresponding to the specific antigen.Antibody affinity, avidity, and cross reactivity: (a) Affinity refers to the strength of single interactions between antigen and antibody, while avidity refers to the strength of all interactions combined. (b) An antibody may cross-react with different epitopes.
Antibodies secreted after binding to one epitope on an antigen may exhibit cross reactivity for the same or similar epitopes on different antigens. Cross reactivity occurs when an antibody binds not to the antigen that elicited its synthesis and secretion, but to a different antigen. Because an epitope corresponds to such a small region (the surface area of about four to six amino acids), it is possible for different macromolecules to exhibit the same molecular identities and orientations over short regions.
Cross reactivity can be beneficial if an individual develops immunity to several related pathogens despite having been exposed to or vaccinated against only one of them. For instance, antibody cross reactivity may occur against the similar surface structures of various Gram-negative bacteria. Conversely, antibodies raised against pathogenic molecular components that resemble self molecules may incorrectly mark host cells for destruction, causing autoimmune damage. Patients who develop systemic lupus erythematosus (SLE) commonly exhibit antibodies that react with their own DNA. These antibodies may have been initially raised against the nucleic acid of microorganisms, but later cross-reacted with self-antigens. This phenomenon is also called molecular mimicry.
Serology
Serology is the study of blood serum and other bodily fluids for the identification of antibodies.Learning Objectives
Describe how serology can be used to identify antibodies in blood serum and other bodily fluidsKey Takeaways
Key Points
- Serology is based on detecting immunoglobulin levels during the course of an infection.
- Serological techniques can differentiate between IgM and IgG antibodies, thus determining the stage of the infection.
- Serological techniques are important for the diagnosis of immunological diseases.
Key Terms
- immunoglobulin G: Most abundant antibody isotype secreted by plasma B cells.
- immunoglobulin M: largest antibody produced by B cells and the first to appear in response to initial exposure to antigen.
- serology: the scientific study of blood serum and other bodily fluids.
A primary immune response occurs when a B cell sees an antigen for the first time. Antigen binding to the surface of the B cell stimulates the production of antibodies that are capable of binding directly to the antigen. Because this first recognition process takes time for antibody development, there is an initial delay for the body to fight the invading antigens. Immunoglobulin M (IgM) is an antibody produced during the primary immune response and plays a significant role fighting infection. When an antigen is introduced into the body for the first time, large quantities of IgM are produced. Meanwhile, the B cells are producing highly specific Immunoglobulin G (IgG) more slowly. Once IgG is produced in quantity, the IgG plays a greater role in the removal of antigens from the body due to its ability to bind to the antigen molecules more tightly. Through the course of an infection, a rapid spike of circulating IgM can be seen in the bloodstream. This is followed by a decrease of IgM as the amount of IgG increases. Medical laboratory personnel can identify the course and duration of an infection by measuring the ratio of IgM to IgG in the bloodstream. A ratio high in IgM indicates that an infection is in its early stages, while a ratio high in IgG indicates that the infection is in its later stage.

Immune response: When B and T cells begin to replicate, some of the offspring that they produce will end up becoming long-lived memory cells. These memory cells will remember all specific pathogens encountered during the animal's lifetime and can thus call forth a strong response if the pathogen ever invades the body again.
Precipitation Reactions
Precipitation reactions are serological assays for the detection of immunoglobulin levels from the serum of a patient with infection.Learning Objectives
Describe how precipitation reactions can be used for the detection of immunoglobulin levels in the serum of a patientKey Takeaways
Key Points
- Precipitation assays are performed in semi-solid media such as agar or agarose where antibodies and antigens can diffuse toward one another and form a visible line of precipitation.
- There are several precipitation methods applied in the diagnostic laboratory. These include single, double, and electroimmunodiffusion.
- The most widely used gold standard precipitation methods are Ouchterlony test and Mancini test.
Key Terms
- precipitin: Any antibody which reacts with an antigen to form a precipitate.
Precipitation reaction: Difference in the visual appearance of an aggregate and a precipitate.
Agglutination Reactions
Agglutination reactions are used to assess the presence of antibodies in a specimen by mixing it with particulate antigens.Learning Objectives
Describe how agglutination reactions can be used to assess the presence of antibodies in a specimenKey Takeaways
Key Points
- Agglutination reactions produce visible aggregates of antibody - antigen complexes when antibodies or antigens are conjugated to a carrier.
- Carriers used in agglutination methods could be artificial (e.g., latex or charcoal) or biological (e.g., erythrocytes ).
- There are various methods of agglutination reactions that follow the same principle, but they differ in the elements they employ based on the desired endpoint and the main purpose of the test.
Key Terms
- avidity: The measure of the synergism of the strength of individual interactions between proteins.
- erythrocytes: Red blood cells.
- agglutination: the clumping together of red blood cells or bacteria, usually in response to a particular antibody
In latex agglutination, many antibody molecules are bound to latex beads (particles), which increases the number of antigen-binding sites. If an antigen is present in a test specimen, it will bind to the antibody and form visible, cross-linked aggregates. Latex agglutination can also be performed with the antigen conjugated to the beads for testing the presence of antibodies in a serum specimen.
Flocculation tests are designed for antibody detection and are based on the interaction of soluble antigens with antibodies, producing a precipitate of fine particles that can be seen with the naked eye.
Direct bacterial agglutination uses whole pathogens as a source of antigen. It measures the antibody level produced by a host infected with that pathogen. The binding of antibodies to surface antigens on the bacteria results in visible clumps.
Hemagglutination uses erythrocytes as the biological carriers of bacterial antigens, and purified polysaccharides or proteins for determining the presence of corresponding antibodies in a specimen.

Hemagglutination assay: Red blood cells are used as carriers to detect antibodies from a patient's serum.
Neutralization Reaction
Neutralization reactions are used to inactivate viruses and evaluate neutralizing antibodies.Learning Objectives
Describe how neutralizing antibodies serve to block viral attachment to cells thus inhibiting viral replicationKey Takeaways
Key Points
- When a vertebrate is infected with a virus, antibodies are produced against it. Some of the antibodies can block viral infection by neutralization which is usually the result of a formation of a virus-antibody complex. This complex can prevent viral infections in many ways.
- Neutralizing antibodies have shown potential in the treatment of retroviral infections such as HIV. Recently, potent and broadly neutralizing human antibodies against influenza have been reported.
- In diagnostic immunology and virology laboratories, the evaluation of neutralizing antibodies, which destroy the infectivity of viruses, can be measured by the neutralization method.
Key Terms
- neutralization: In the immunological sense refers to the ability of antibodies to block the site(s) on bacteria or viruses that they use to enter their target cell. One example of this within biology is a neutralizing antibody.
- virion: A single individual particle of a virus (the viral equivalent of a cell).
- endosomes: membrane-bound compartments inside eukaryotic cells.
Neutralizing antibody: Antibody neutralizing an antigen and preventing its biological effect.
Neutralizing antibodies have shown potential in the treatment of retroviral infections. Medical professionals and researchers have shown how the encoding of genes which influence the production of this particular type of antibody could help in the treatment of infections that attack the immune system. Experts in the field have used HIV treatment as an example of infections these antibodies can treat. Recently, potent and broadly neutralizing human antibodies against influenza have been reported, and have suggested possible strategies to generate an improved vaccine that would confer long-lasting immunity. Another disease which has been linked to the production of neutralizing antibodies is multiple sclerosis.
In diagnostic immunology and virology laboratories, the evaluation of neutralizing antibodies, which destroy the infectivity of viruses, can be measured by the neutralization method. In this procedure, patient serum is mixed with a suspension of infectious virus particles of the same type as those suspected of causing disease in the patient. A control suspension of virus is mixed with normal serum and is then inoculated into an appropriate cell culture. If the patient serum contains antibody to the virus, the antibody will bind to the virus particles and prevent them from invading the cells in culture, thereby neutralizing the infectivity of the virus. This technique is labor-intensive, demanding, and time consuming. It application is restricted to laboratories that perform routine viral cultures and related diagnosis.
Complement Fixation
Complement fixation is a method that demonstrates antibody presence in patient serum.Learning Objectives
Describe how the complement fixation assay can be used to test for the presence of a specific antibody in a patient's serumKey Takeaways
Key Points
- Complement fixation method is more demanding than other systems used to detect antibodies and has been replaced by more sensitive techniques.
- Complement fixation requires several elements mixed together in optimum concentrations.
- The indicator system for the complement fixation assay is sheep red blood cells bound to anti-sheep immunoglobulin G.
Key Terms
- immunoglobulin G: Most abundant antibody isotype secreted by plasma B cells.

The complement pathway: Complement binds to antigen-antibody complex and leads to cell lysis.
Fluorescent Antibodies
Fluorescent antibodies are antibodies that have been tagged with a fluorescent compound to facilitate their detection in the laboratory.Learning Objectives
Describe how fluorescent antibody conjugates can be used in immunoassays for protein detectionKey Takeaways
Key Points
- Fluorescent labeling of antibodies is used in place of radioisotopes and enzymes to enhance the sensitivity and specificity of immunological tests.
- Fluorescent antibodies can be used to stain proteins from patient serum or tissue sections fixed on a slide or live cells in suspension.
- Fluorescent antibodies can be detected with a fluorescent microscope or a flow cell sorter.
Key Terms
- radioisotope: A radioactive isotope of an element.
Fluorescent techniques are very specific and sensitive, so fluorescent antibody-based techniques require a fluorescent microscope. A fluorescent substance absorbs light of one wavelength and emits light of a longer wavelength. Fluorescein fluoresces an intense apple-green color when excited under fluorescent microscopy. The chemical manipulation in labeling antibodies with fluorescent dyes to permit detection by direct microscopy examination does not impair antibody activity.

Flow cell sorter: This instrument is used to analyze live cells in suspension after staining them with fluorescent antibodies.
In the direct technique, a fluorescent antibody is used to detect antigen-antibody reactions at a microscopic level. The inhibition immunofluorescent assay is a blocking test in which an antigen is first exposed to an unlabeled antibody, then to a fluorescent antibody, and is finally washed and examined. Indirect immunofluorescence assay is based on the ability of antibodies to react with antigens as well as act as antigens and react with anti-antibody (anti-immunoglobulin). This technique is used extensively for the detection of autoantibodies and antibodies to tissue and cellular antigens. The methods described are mostly performed on glass slides with patient serum or tissue sections. Immunofluorescence can also be performed to identify specific antigens on live cells in suspension. This method is known as flow cytometry and requires a flow cell sorter rather than a fluorescent microscope.
Enzyme-Linked Immunosorbent Assay (ELISA)
Enzyme-linked immunosorbent assay (ELISA) is a solid-phase enzyme immunoassay used to detect the presence of a substance in solution.Learning Objectives
Describe how the Enzyme-linked immunosorbent assay (ELISA) can be used to detect and quantitate antigens, antibodies and allergensKey Takeaways
Key Points
- ELISA is a quantitative technique that measures serum concentration of antigens, antibodies, and allergens.
- Standard ELISA uses antibody-antigen-antibody trapping principle with the second antibody coupled to an enzyme. If the complex is formed, the enzyme converts a clear solution into a colored one that can be measured with a spectrophotometer.
- ELISA is performed in a muti-well microtiter plate. In addition to the test solution, standard solutions are added with known antigen concentration. These solutions will be used to infer the concentration of the antigen being tested.
Key Terms
- spectrophotometrically: By using spectrophotometry.
- epitope: That part of a biomolecule (such as a protein) that is the target of an immune response.
Several variations of ELISA, seen in, exist but the most commonly used method is the sandwich ELISA. The sandwich assay uses two different antibodies that are reactive with different epitopes on the antigen with a concentration that needs to be determined. A fixed quantity of one antibody is attached to a series of replicate solid supports, such as plastic microtiter multi-well plate. Test solutions containing antigen at an unknown concentration are added to the wells and allowed to bind. Unbound antigen is removed by washing, and a second antibody which is linked to an enzyme is allowed to bind. This second antibody-enzyme complex constitutes the indicator system of the test. The antigen serves as bridge, so the more antigen in the test solution, the more enzyme-linked antibody will bind. The test solution is used in parallel with a series of standard solutions with known concentrations of antigen that serve as control and reference. The results obtained from the standard solutions are used to construct a binding curve of the second antibody as a function of antigen concentration. The concentration of antigens can be inferred from absorbance readings of standard solutions.
Sandwich ELISA: Two antibodies recognize different epitopes on same antigen.

ELISA: Direct ELISA diagram using a viral antigen as an example.
Immunoblot Procedures
Immunoblot is a technique for analyzing proteins via antigen-antibody specific reactions.Learning Objectives
Describe how Western blotting allows individuals to detect specific solubilized proteins from serum or cell or tissue extractsKey Takeaways
Key Points
- In immunoblot techniques such as Western blot analysis, proteins are separated by electrophoresis and transferred onto nitrocellulose sheets, then are identified by their reaction with labeled antibodies.
- Electrophoresis uses an electric current to separate proteins based on their size. Big proteins migrate slower and are represented by the highest bands on the blot, while small proteins migrate faster and are indicated by the lowest bands on the blot.
- Immunoblot assays are usually performed to confirm results obtained by other techniques such as ELISA.
Key Terms
- sodium dodecyl sulfate: strong detergent agent used to reduce and unfold native protein.
- blot: method of transferring protein, DNA, or RNA onto a carrier membrane.
Immunoblotting Procedures

Immunoblot: proteins separated by molecular weight and represented by a dark band on a blot.
Applications of Immunoblotting
Western blotting is a routine molecular biology method that can be used to semi-quantitatively compare protein levels between extracts. The size separation, prior to blotting, allows the protein molecular weight to be gauged, as compared with known molecular weight markers. Immunoblots are most often used in research settings and are usually performed to confirm results from ELISA or other immunoassays. In clinical diagnostic settings, immunoelectrophoresis is applied, which involves the electrophoresis of serum or urine followed by immunodiffusion. The size and position of precipitation bands provides the same type of information about antibody amount as the double immunodiffusion method.Tests That Differentiate Between T Cells and B cells
Methods used to differentiate T cells and B cells include staining cell surface receptors and functional assays like the T lymphocyte cytotoxicity assay.Learning Objectives
Describe how T cells and B cells can be differentiated using staining of cell surface receptors and functional assays like the T lymphocyte cytotoxicity assayKey Takeaways
Key Points
- There are two types of lymphocytes: B cells and T cells. These two components of the immune system have different functions but cooperate to fight infection.
- T cells elicit cell-mediated immune response, while B cells elicit humoral immunity.
- Lymphocytes are the only immunologically specific cellular components of the immune system.
Key Terms
- cytotoxic: of, relating to, or being a cytotoxin
SEM Lymphocyte: A scanning electron microscope (SEM) image of a single human lymphocyte.
Traditionally, T-lymphocytes were defined by their ability to form E-rosettes when they bind selectively to sheep erythrocytes. T-lymphocytes express CD3, CD4, CD8, or CD25 markers. B-lymphocytes express CD19 marker. The expression of different markers allows the separation/ differentiation of T and B cells. Another functional assay used to identify T-lymphocyte is the cytotoxic activity assay. This assay is based on measuring the killing ability that a determined number of T lymphocytes have for a certain number of target cells when both populations are placed together. B-lymphocytes have membrane-bound immunoglobulins that can be stained with anti-immunoglobulin labeled with fluorescent dyes and detected with a fluorescent microscope. More modern techniques like flow cytometry and immunohistochemistry are commonly used and rely on the use of fluorescent antibodies. These techniques are based on staining B and T cells for unique cell surface markers known as cluster of differentiation (CD).
Cluster of differentiation: T and B lymphocytes express unique CD markers.
In Vivo Testing
In vivo testing using animal models of disease help discover new ways of solving complex health problems.Learning Objectives
Describe how animals can be used for diagnostic antibody productionKey Takeaways
Key Points
- In vivo testing is necessary for medical and research purposes. The medical field benefits from animal models to test the safety of drugs before they are used on patients. The research field benefits from in vivo testing by validating in vitro findings in vertebrates closest to humans.
- The most used animal models are mice, rats, and other rodents.
- In vivo testing is useful for the production of polyclonal antibodies applied in immunoassays and diagnostic immunology.
Key Terms
- in vitro: In an artificial environment outside the living organism.
- antiserum: a serum prepared from human or animal sources containing antigens specific for combatting an infectious disease
- in vivo: Within a living organism.
In Vivo Testing
In vivo methods refer to the use of animals as a conduit to generate purified polyclonal antibody solutions ( antiserum ) for research purposes. Polyclonal antibodies are applied in immunological assays to diagnose disease.In vivo testing follows strict guidelines and humane animal use ethics. The protocol for diagnostic antibody production in animals follows multiple steps. Animals are injected with microbes or antigenic fragments that elicit an immune response; the immune response is allowed to develop for 1-2 weeks, after which blood is harvested. This blood now contains antibodies created from the antigens that were introduced into the animals. Antibodies are purified from the serum to make antiserum or a purified antibody solution for one particular antigen.

A white laboratory rat: Animals are used in laboratory experiments to translate in vitro findings.
Mice, and other rodents such as rats and hamsters, make up over 90% of the animals used in biomedical research. In addition to having bodies that work similar to humans and other animals, rodents are small in size, easy to handle, relatively inexpensive to buy and keep, and produce many offspring in a short period of time. In vivo testing remains a crucial step for the evaluation of in vitro experimental findings and the production of immunological solutions needed for the diagnosis of human diseases.
The Future of Diagnostic Immunology
The future of diagnostic immunology lies in the production of specific antibody-based assays and the development of improved vaccines.Learning Objectives
Describe how immunologic methods are used in the treatment and prevention of infectious diseases and immune-mediated diseasesKey Takeaways
Key Points
- Diagnostic immunology has considerably advanced due to the development of automated methods.
- New technology takes into account saving samples, reagents, and reducing cost.
- The future of diagnostic immunology faces challenges in the vaccination field for protection against HIV and as anti-cancer therapy.
Key Terms
- ELISA: enzyme-linked immunosorbent assay; assay based on the principle of antibody-antigen interaction.
The Future of Diagnostic Immunology
Modern immunology relies heavily on the use of antibodies as highly specific laboratory reagents. The diagnosis of infectious diseases, the successful outcome of transfusions and transplantations, and the availability of biochemical and hematologic assays with extraordinary specificity and sensitivity capabilities all attest to the value of antibody detection.Immunologic methods are used in the treatment and prevention of infectious diseases and in the large number of immune -mediated diseases. Advances in diagnostic immunology are largely driven by instrumentation, automation, and the implementation of less complex and more standardized procedures. Examples of such processes are as follows:
- miniaturization (use of microtiter plates to save samples and reagents),
- amplified immunoassays (chemiluminesent ELISA),
- flow cytometry with monoclonal antibodies,
- immunoglobulins,
- molecular methods (polymerase chain reactions).
These methods have facilitated the performance of tests and have greatly expanded the information that can be developed by a clinical laboratory. The tests are now used for clinical diagnosis and the monitoring of therapies and patient responses. Immunology is a relatively young science and there is still so much to discover. Immunologists work in many different disease areas today that include allergy, autoimmunity, immunodeficiency, transplantation, and cancer.
Interestingly, no matter what the areas of expertise, vaccine development and understanding how vaccines work pose the greatest challenges. The vaccines currently used primarily generate an antibody response, which is able to attack free-moving pathogens, but is unable to fight bacteria and viruses, such as human immunodeficiency virus (HIV). In the cancer research field, vaccines that stimulate the immune system to attack tumor cells are undergoing clinical trials.

Antibody sculpture: Angel of the West is a sculpture by Julian Voss-Andreae based on the antibody structure.