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Bioassay setup
Planktonic crustaceans exposed to different experimental conditions
A biological test system (here: Daphnia magna) is exposed to various experimental conditions (here: several microplastics preparations), to which it reacts.
A microplate with liquids in a range of red colors
Some indicator of these reactions (e.g. a color change) is assessed, typically in a highly automated fashion through microplates like this.

A bioassay is an analytical method to determine concentration or potency of a substance by its effect on living cells or tissues.[1] Bioassays are quantitative biological assays used to estimate the potency of agents by observing their effects on living animals (in vivo) or tissue/cell culture systems (in vitro).[2]

A bioassay experiment can either be qualitative or quantitative, direct or indirect.[3] If the measured response is binary, the assay is qualitative, if not, it is quantitative.[3]

Bioassay is used to detect biological hazards or give a quality assessment of a mixture.[4] Bioassay is often used to monitor water quality and also sewage discharge and its impact on surrounding.[citation needed] It is also used to assess the environmental impact and safety of new technologies and facilities.[citation needed]


Bioassay is a biochemical test to estimate the relative potency of a sample compound to a standard compound.[3][1] Typical bioassay involves a stimulus (ex. drugs) applied to a subject (ex. animals, tissues, plants) and a response (ex. death) of the subject is triggered and measured.[5] The intensity of stimulus is varied by doses and depending on this intensity of stimulus, a change/response will be followed by a subject.[5]


The first uses of bioassay dates back to as early as the late 19th century, when the foundation of bioassays was laid down by a German physician, Paul Ehrlich.[6] He introduced the concept of standardization by the reactions of living matter.[6][5] His bioassay on diphtheria antitoxin was the first bioassay to receive recognition.[7] His use of bioassay was able to discover that administration of gradually increasing dose of diphtheria in animals stimulated production of antiserum.[8]

One well known example of a bioassay is the "canary in the coal mine" experiment.[9] To test for methane, miners would take methane-sensitive canaries to coal mines to ensure safe air.

Many of the early bioassays consisted of using animals to test carcinogenicity of chemicals.[10] In 1915, Yamaigiwa Katsusaburo and Koichi Ichikawa tested the carcinogenicity of coal tar using the inner surface of rabbit's ears.[10]

Through 1940s and 1960s, animal bioassay was primarily used to test for toxicity and safety of drugs, food additives and pesticides.[10]

In late 1960s and 1970s, reliance on bioassay increased as the public concern for occupational and environmental hazards increased.[10] While before this health risks of certain chemicals such as pesticide was tested in animal bioassay, it was still rare and testing was not seen often.[10]


Direct assay[edit]

- The stimulus/standard sufficiently produces measurable and specific response.[5] The response must be clear, easily recognized, and directly measured.[5]

Indirect assay based on quantitative response[edit]

- The relationship between the dose and the response is first ascertained.[5] Then the dose corresponding to a given response is obtained from the relation for each preparation separately.[5]

Indirect assay based on quantal response[edit]

- The assay involves 'all or none' response (ex. life or death).[citation needed] The response is produced by threshold effect.[citation needed]


ELISA (Enzyme-linked immunosorbent assay)[edit]

ELISA plate with various cortisol levels

ELISA is a quantitative analytical method that measures absorbance of color change from antigen-antibody reaction (ex. Direct, indirect, sandwich, competitive).[11] ELISA is used to measure variety of substances in the human body, from cortisol levels for stress to glucose level for diabetes.

Home pregnancy test[edit]

Home pregnancy test involves ELISA to detect the increase of human chorionic gonadotropin (hCG) during pregnancy.[12]

HIV test[edit]

HIV test also uses indirect ELISA to detect HIV antibody caused by infection.[12]

See also[edit]


  1. ^ a b Hoskins, W. M.; Craig, R. (1962-01-01). "Uses of Bioassay in Entomology". Annual Review of Entomology. 7 (1): 437–464. doi:10.1146/annurev.en.07.010162.002253. ISSN 0066-4170. PMID 14449182.
  2. ^ Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, Food and Drug Administration, January 2011, p. 7
  3. ^ a b c Laska, E M; Meisner, M J (1987-04-01). "Statistical Methods and Applications of Bioassay". Annual Review of Pharmacology and Toxicology. 27 (1): 385–397. doi:10.1146/ ISSN 0362-1642. PMID 3579242.
  4. ^ Prinsloo, Gerhard; Papadi, Georgia; Hiben, Mebrahtom G.; Haan, Laura de; Louisse, Jochem; Beekmann, Karsten; Vervoort, Jacques; Rietjens, Ivonne M.C.M. (2017). "In vitro bioassays to evaluate beneficial and adverse health effects of botanicals: promises and pitfalls". Drug Discovery Today. 22 (8): 1187–1200. doi:10.1016/j.drudis.2017.05.002. PMID 28533190.
  5. ^ a b c d e f g Saha, G. M (29 November 2002). Design and Analysis for Bioassays. Kolkata: Indian Statistical Institute. pp. 61–76.
  6. ^ a b Van Noordwijk, Jacobus (1989). "Bioassays in whole animals". Journal of Pharmaceutical and Biomedical Analysis. 7 (2): 139–145. doi:10.1016/0731-7085(89)80077-9. PMID 2488614.
  7. ^ Analysis of foods and beverages : modern techniques. Charalambous, George, 1922-1994. Orlando: Academic Press. 1984. ISBN 0121691608. OCLC 9682930.CS1 maint: others (link)
  8. ^ Bosch, Fèlix; Rosich, Laia (2008). "The Contributions of Paul Ehrlich to Pharmacology: A Tribute on the Occasion of the Centenary of His Nobel Prize". Pharmacology. 82 (3): 171–179. doi:10.1159/000149583. ISSN 0031-7012. PMC 2790789. PMID 18679046.
  9. ^ "Environmental Inquiry - How Are Bioassays Used in the Real World?". Retrieved 2017-12-01.
  10. ^ a b c d e Beyer, L. A.; Beck, B. D.; Lewandowski, T. A. (2011-04-01). "Historical perspective on the use of animal bioassays to predict carcinogenicity: Evolution in design and recognition of utility". Critical Reviews in Toxicology. 41 (4): 321–338. doi:10.3109/10408444.2010.541222. ISSN 1040-8444. PMID 21438739. S2CID 2269998.
  11. ^ Aydin, Suleyman (2015). "A short history, principles, and types of ELISA, and our laboratory experience with peptide/protein analyses using ELISA". Peptides. 72: 4–15. doi:10.1016/j.peptides.2015.04.012. PMID 25908411. S2CID 36486495.
  12. ^ a b Manz, Andreas; Dittrich, Petra S.; Pamme, Nicole; Iossifidis, Dimitri (2015). Bioanalytical chemistry. Manz, A. (Andreas), Dittrich, Petra S., 1974-, Pamme, Nicole., Iossifidis, Dimitri. (Second ed.). London. ISBN 9781783266715. OCLC 897825792.