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Pyrogen Test
The pyrogen test is used to detect the presence of pyrogens in pharmaceuticals,
particularly injectable drugs, which can cause fever when administered.
Pyrogens are substances that induce fever, typically produced by bacterial
endotoxins or other microbial products.
MCQs related to the pyrogen test:
1. The primary purpose of the pyrogen test is to:
A) Detect bacterial contamination in food
B) Identify antibiotic resistance in bacteria
C) Ensure that pharmaceuticals do not cause fever when injected
D) Determine the effectiveness of disinfectants
Answer: C) Ensure that pharmaceuticals do not cause fever when injected
2. The test used to detect pyrogens in pharmaceutical products is called the:
A) LAL test
B) Elek test
C) Coagulase test
D) ELISA
Answer: A) LAL test
3. The LAL test is based on the reaction of bacterial endotoxins with:
A) Rabbit blood
B) Limulus amebocyte lysate
C) Mouse serum
D) E. coli cultures
Answer: B) Limulus amebocyte lysate
4. The rabbit pyrogen test involves:
A) Injecting the sample into a rabbit and monitoring temperature changes
B) Using an ELISA assay to detect endotoxins
C) Performing a Gram stain on bacterial cultures
D) PCR amplification of toxin genes
Answer: A) Injecting the sample into a rabbit and monitoring temperature changes
5. Which of the following statements is true regarding the LAL test?
A) It uses bacterial cultures to detect pyrogens.
B) It involves a color change reaction in the presence of pyrogens.
C) It is a quantitative test for measuring the level of endotoxins.
D) It requires the use of live animals for testing.
Answer: C) It is a quantitative test for measuring the level of endotoxins.
6. The rabbit pyrogen test is typically performed by:
A) Injecting the drug into the bloodstream of rabbits and monitoring their body
temperature
B) Adding a reagent to bacterial cultures and measuring the color change
C) Performing a coagulation test on blood samples
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D) Amplifying DNA from bacterial cultures
Answer: A) Injecting the drug into the bloodstream of rabbits and monitoring their body
temperature
7. The LAL test is particularly useful because it:
A) Detects only bacterial growth
B) Provides a rapid result for endotoxin detection
C) Requires a large amount of sample
D) Measures only gram-positive bacteria
Answer: B) Provides a rapid result for endotoxin detection
8. The pyrogen test is crucial for which type of products?
A) Oral medications
B) Topical creams
C) Injectable drugs and vaccines
D) Over-the-counter supplements
Answer: C) Injectable drugs and vaccines
9. In the LAL test, a positive result indicates:
A) Absence of endotoxins
B) Presence of endotoxins
C) Presence of bacterial contamination
D) Effective sterilization
Answer: B) Presence of endotoxins
10. Which of the following is an advantage of using the LAL test over the rabbit
pyrogen test?
A) The LAL test is less specific.
B) The LAL test does not require the use of live animals.
C) The LAL test is less sensitive.
D) The LAL test is more time-consuming.
Answr: B) The LAL test does not require the use of live animals.
11. What is the main limitation of the rabbit pyrogen test?
A) It cannot detect endotoxins.
B) It requires a large number of animals.
C) It is a non-quantitative test.
D) It is not suitable for testing pharmaceutical products.
Answer: B) It requires a large number of animals.
12. The LAL test is used in which of the following applications?
A) Food safety testing
B) Environmental monitoring
C) Pharmaceutical quality control
D) Water purity testing
Answer: C) Pharmaceutical quality control
13. The pyrogen test is important for ensuring the safety of which type of medical
products?
A) Oral antibiotics
B) Blood transfusions
C) Injectable vaccines
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D) Topical ointments
Answer: C) Injectable vaccines
14. A false positive result in the LAL test may be caused by:
A) Presence of endotoxins
B) Interference from other substances in the sample
C) High temperature conditions
D) Low pH levels
Answer: B) Interference from other substances in the sample
15. Which test method is considered a replacement for the rabbit pyrogen test in
many laboratories?
A) ELISA
B) LAL test
C) Coagulase test
D) PCR
Answer: B) LAL test
16. The LAL test is based on a reaction between endotoxins and which
component found in horseshoe crab blood?
A) Hemoglobin
B) Hematocrit
C) Limulus amebocyte lysate
D) Coagulase
Answer: C) Limulus amebocyte lysate
17. What is the main advantage of the LAL test over the rabbit pyrogen test?
A) It provides qualitative results only.
B) It requires more complex procedures.
C) It is less specific and less sensitive.
D) It is faster, more reproducible, and does not use live animals.
Answer: D) It is faster, more reproducible, and does not use live animals.
18. The bacterial endotoxins in the LAL test cause which type of reaction?
A) Coagulation reaction
B) Colorimetric reaction
C) Precipitation reaction
D) Hemolytic reaction
Answer: A) Coagulation reaction
19. The pyrogen test is used to ensure the safety of which of the following?
A) Non-injectable medications
B) Injectable drugs and medical devices
C) Household cleaners
D) Over-the-counter medications
Answer: B) Injectable drugs and medical devices
20. The endotoxin threshold limit for parenteral products using the LAL test is
generally expressed in:
A) Units per milliliter
B) Micrograms per milliliter
C) Nanograms per milliliter
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D) CFU per milliliter
Answer: A) Units per milliliter
21. The pyrogen test is specifically important for which type of product stability?
A) Long-term stability
B) Immediate stability
C) Thermal stability
D) Sterility
Answer: A) Long-term stability
22. In the rabbit pyrogen test, a fever response is detected by:
A) Measuring changes in heart rate
B) Monitoring changes in body temperature
C) Analyzing blood cell counts
D) Assessing changes in respiratory rate
Answer: B) Monitoring changes in body temperature
23. Which test is more suitable for detecting endotoxins in water or medical
devices?
A) Rabbit pyrogen test
B) LAL test
C) ELISA
D) Coagulase test
Answer: B) LAL test
24. The LAL test can be used in a variety of formats, including:
A) Gel clot
B) Turbidimetric
C) Chromogenic
D) All of the above
Answer: D) All of the above
25. What type of sample interference can affect the accuracy of the LAL test?
A) High pH levels
B) Presence of proteins or surfactants
C) Low temperature
D) High temperature
Answer: B) Presence of proteins or surfactants
26. The rabbit pyrogen test can detect pyrogens by observing:
A) Changes in blood pH
B) Fever response in rabbits
C) Color changes in a test solution
D) Hemolysis in blood samples
Answer: B) Fever response in rabbits
27. The endotoxin limit for intravenous drugs is typically expressed in which
unit?
A) Endotoxin Units (EU) per milliliter
B) Micrograms per milliliter
C) Nanograms per milliliter
D) CFU per milliliter
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Answer: A) Endotoxin Units (EU) per milliliter
28. Which method is commonly used to confirm a positive LAL test result?
A) ELISA
B) Rabbit pyrogen test
C) PCR
D) Coagulase test
Answer: B) Rabbit pyrogen test
29. The LAL test is validated by using:
A) Standard endotoxin solutions
B) Natural samples
C) Chemical indicators
D) Bacterial cultures
Answer: A) Standard endotoxin solutions
30. What is the main reason for using the LAL test instead of the rabbit pyrogen
test in many laboratories?
A) The LAL test is more expensive.
B) The LAL test is less accurate.
C) The LAL test is faster and does not involve live animals.
D) The LAL test is less specific.
Answer: C) The LAL test is faster and does not involve live animals.
31. The Limulus Amebocyte Lysate (LAL) test is sensitive to which type of
pyrogens?
A) Endotoxins from Gram-negative bacteria
B) Exotoxins from Gram-positive bacteria
C) Viral particles
D) Fungal toxins
Answer: A) Endotoxins from Gram-negative bacteria
32. In which of the following situations is the rabbit pyrogen test still commonly
used?
A) Testing for endotoxins in blood products
B) Testing for pyrogens in injectable pharmaceuticals
C) Quality control of non-injectable drugs
D) Testing environmental samples
Answer: B) Testing for pyrogens in injectable pharmaceuticals
33. The Limulus Amebocyte Lysate (LAL) test can be used to detect endotoxins
at concentrations as low as:
A) 0.1 EU/mL
B) 1 EU/mL
C) 10 EU/mL
D) 100 EU/mL
Answer: A) 0.1 EU/mL
34. Which of the following is a disadvantage of the rabbit pyrogen test compared
to the LAL test?
A) The rabbit pyrogen test is less sensitive.
B) The rabbit pyrogen test is less specific.
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Zenith Study Center License and Loksewa
C) The rabbit pyrogen test is more labor-intensive and requires live animals.
D) The rabbit pyrogen test provides faster results.
Answer: C) The rabbit pyrogen test is more labor-intensive and requires live animals.
35. The LAL test is particularly useful for which type of product quality control?
A) Solid dosage forms
B) Injectable drugs and biologics
C) Over-the-counter creams
D) Airborne pathogens
Answer: B) Injectable drugs and biologics
36. The LAL test involves which of the following components for detecting
endotoxins?
A) Clotting factors from blood
B) A colorimetric indicator
C) Limulus amebocyte lysate
D) A fluorescent dye
Answer: C) Limulus amebocyte lysate
37. What does a positive result in the LAL test indicate?
A) Presence of bacterial growth
B) Presence of endotoxins
C) Presence of viable microorganisms
D) Presence of chemical contaminants
Answer: B) Presence of endotoxins
38. The gel-clot LAL test method is most appropriate for:
A) Quantitative analysis of endotoxins
B) Qualitative detection of endotoxins
C) Sterility testing
D) Protein concentration measurement
Answer: B) Qualitative detection of endotoxins
39. What type of samples can be tested using the LAL test?
A) Blood samples
B) Environmental water samples
C) Injectable pharmaceuticals
D) All of the above
Answer: D) All of the above
40. Which of the following is a limitation of the LAL test?
A) It cannot detect endotoxins in the presence of high concentrations of proteins.
B) It is less sensitive than the rabbit pyrogen test.
C) It requires live animals for testing.
D) It is not suitable for aqueous solutions.
Answer: A) It cannot detect endotoxins in the presence of high concentrations of proteins.
41. The endotoxin limit for injectable drugs is generally set according to:
A) The drug’s volume and route of administration
B) The drug’s chemical composition
C) The manufacturing process
D) The drug’s storage conditions
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Answer: A) The drug’s volume and route of administration
42. Which of the following conditions must be met for the LAL test to be valid?
A) The test must be performed in a sterile environment.
B) The sample must be heated before testing.
C) The sample must be diluted to a specific concentration.
D) The sample must be centrifuged before testing.
Answer: A) The test must be performed in a sterile environment.
43. Which of the following factors does NOT affect the outcome of the LAL test?
A) pH of the sample
B) Temperature during the test
C) Sample volume
D) Sample color
Answer: D) Sample color
44. The LAL test results can be interpreted using:
A) A visual inspection of color change
B) A fluorescence reader
C) A spectrophotometer
D) A temperature logger
Answer: A) A visual inspection of color change
45. For which type of sample is the LAL test method NOT typically used?
A) Injectable drugs
B) Blood products
C) Environmental air samples
D) Medical devices
Answer: C) Environmental air samples
46. In the rabbit pyrogen test, the maximum allowable temperature rise in the
rabbit is:
A) 0.5°C
B) 1.0°C
C) 1.5°C
D) 2.0°C
Answer: B) 1.0°C
47. In the LAL test, a sample is considered to be pyrogen-free if:
A) There is no visible change in the test solution
B) The test solution turns blue
C) The test solution turns yellow
D) The test solution forms a gel
Answer: A) There is no visible change in the test solution
48. The LAL test is designed to detect endotoxins at concentrations lower than:
A) 1 EU/mL
B) 10 EU/mL
C) 100 EU/mL
D) 1000 EU/mL
Answer: A) 1 EU/mL
49. The rabbit pyrogen test is sometimes referred to as the:
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A) Rabbit fever test
B) Pyrogenic reaction test
C) Limulus test
D) Endotoxin test
Answer: B) Pyrogenic reaction test
50. The choice between using the LAL test and the rabbit pyrogen test often
depends on:
A) Cost and availability of test reagents
B) The type of sample being tested
C) Regulatory requirements and animal welfare considerations
D) The specific bacterial species involved
Answer: C) Regulatory requirements and animal welfare considerations
51. The Limulus Amebocyte Lysate (LAL) test is sensitive to which type of
pyrogens?
A) Endotoxins from Gram-negative bacteria
B) Exotoxins from Gram-positive bacteria
C) Viral particles
D) Fungal toxins
Answer: A) Endotoxins from Gram-negative bacteria
52. In which of the following situations is the rabbit pyrogen test still commonly
used?
A) Testing for endotoxins in blood products
B) Testing for pyrogens in injectable pharmaceuticals
C) Quality control of non-injectable drugs
D) Testing environmental samples
Answer: B) Testing for pyrogens in injectable pharmaceuticals
53. The Limulus Amebocyte Lysate (LAL) test can be used to detect endotoxins
at concentrations as low as:
A) 0.1 EU/mL
B) 1 EU/mL
C) 10 EU/mL
D) 100 EU/mL
Answer: A) 0.1 EU/mL
54. Which of the following is a disadvantage of the rabbit pyrogen test compared
to the LAL test?
A) The rabbit pyrogen test is less sensitive.
B) The rabbit pyrogen test is less specific.
C) The rabbit pyrogen test is more labor-intensive and requires live animals.
D) The rabbit pyrogen test provides faster results.
Answer: C) The rabbit pyrogen test is more labor-intensive and requires live animals.
55. The LAL test is particularly useful for which type of product quality control?
A) Solid dosage forms
B) Injectable drugs and biologics
C) Over-the-counter creams
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Zenith Study Center License and Loksewa
D) Airborne pathogens
Answer: B) Injectable drugs and biologics
56. The LAL test involves which of the following components for detecting
endotoxins?
A) Clotting factors from blood
B) A colorimetric indicator
C) Limulus amebocyte lysate
D) A fluorescent dye
Answer: C) Limulus amebocyte lysate
57. What does a positive result in the LAL test indicate?
A) Presence of bacterial growth
B) Presence of endotoxins
C) Presence of viable microorganisms
D) Presence of chemical contaminants
Answer: B) Presence of endotoxins
58. The gel-clot LAL test method is most appropriate for:
A) Quantitative analysis of endotoxins
B) Qualitative detection of endotoxins
C) Sterility testing
D) Protein concentration measurement
Answer: B) Qualitative detection of endotoxins
59. What type of samples can be tested using the LAL test?
A) Blood samples
B) Environmental water samples
C) Injectable pharmaceuticals
D) All of the above
Answer: D) All of the above
60. Which of the following is a limitation of the LAL test?
A) It cannot detect endotoxins in the presence of high concentrations of proteins.
B) It is less sensitive than the rabbit pyrogen test.
C) It requires live animals for testing.
D) It is not suitable for aqueous solutions.
Answer: A) It cannot detect endotoxins in the presence of high concentrations of proteins.
61. The endotoxin limit for injectable drugs is generally set according to:
A) The drug’s volume and route of administration
B) The drug’s chemical composition
C) The manufacturing process
D) The drug’s storage conditions
Answer: A) The drug’s volume and route of administration
62. Which of the following conditions must be met for the LAL test to be valid?
A) The test must be performed in a sterile environment.
B) The sample must be heated before testing.
C) The sample must be diluted to a specific concentration.
D) The sample must be centrifuged before testing.
Answer: A) The test must be performed in a sterile environment.
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63. Which of the following factors does NOT affect the outcome of the LAL test?
A) pH of the sample
B) Temperature during the test
C) Sample volume
D) Sample color
Answer: D) Sample color
64. The LAL test results can be interpreted using:
A) A visual inspection of color change
B) A fluorescence reader
C) A spectrophotometer
D) A temperature logger
Answer: A) A visual inspection of color change
65. For which type of sample is the LAL test method NOT typically used?
A) Injectable drugs
B) Blood products
C) Environmental air samples
D) Medical devices
Answer: C) Environmental air samples
66. In the rabbit pyrogen test, the maximum allowable temperature rise in the
rabbit is:
A) 0.5°C
B) 1.0°C
C) 1.5°C
D) 2.0°C
Answer: B) 1.0°C
67. In the LAL test, a sample is considered to be pyrogen-free if:
A) There is no visible change in the test solution
B) The test solution turns blue
C) The test solution turns yellow
D) The test solution forms a gel
Answer: A) There is no visible change in the test solution
68. The LAL test is designed to detect endotoxins at concentrations lower than:
A) 1 EU/mL
B) 10 EU/mL
C) 100 EU/mL
D) 1000 EU/mL
Answer: A) 1 EU/mL
69. The rabbit pyrogen test is sometimes referred to as the:
A) Rabbit fever test
B) Pyrogenic reaction test
C) Limulus test
D) Endotoxin test
Answer: B) Pyrogenic reaction test
70. The choice between using the LAL test and the rabbit pyrogen test often
depends on:
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Zenith Study Center License and Loksewa
A) Cost and availability of test reagents
B) The type of sample being tested
C) Regulatory requirements and animal welfare considerations
D) The specific bacterial species involved
Answer: C) Regulatory requirements and animal welfare considerations
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