Test-Positive / Test-Negative Case–Control Study

Test-Positive / Test-Negative Case–Control Study

Dr. Surya Parajuli
Dr. Surya Parajuli 28 Dec 2025

#Test-Positive / Test-Negative Case–Control Study

#🔹 Definition

  • A special type of case–control study.

  • Commonly used in infectious disease epidemiology.

  • Cases and controls are defined by laboratory test results, not by symptoms alone.


#🔹 Study Population

  • All participants:

    • Have similar clinical symptoms (e.g., fever, cough).

    • Have sought healthcare (hospital/OPD).

  • This ensures comparable healthcare-seeking behavior.


#🔹 Group Definition

Cases (Test Positive)

  • Symptomatic individuals.

  • Laboratory test positive for the disease
    (e.g., RT-PCR positive for COVID-19).

Controls (Test Negative)

  • Symptomatic individuals.

  • Laboratory test negative for the same disease.

👉 Key point:
Both groups have similar symptoms; only the test result differs.


#🔹 Exposure Assessment

  • Done retrospectively.

  • Common exposures studied:

    • Vaccination status

    • Contact history

    • Travel history

    • Comorbidities

  • Compare exposure between:

    • Test-positive vs test-negative groups.


#🔹 Measure of Association

  • Odds Ratio (OR) is calculated.

For vaccine studies:

Vaccine Effectiveness (VE)=(1−OR)×100\text{Vaccine Effectiveness (VE)} = (1 - OR) \times 100Vaccine Effectiveness (VE)=(1−OR)×100


#🔹 Purpose of This Design

  • Controls healthcare-seeking bias.

  • Useful during outbreaks and epidemics.

  • Commonly used to assess:

    • Vaccine effectiveness

    • Risk factors for infection


#🔹 Advantages

  • Minimizes selection bias.

  • Cost-effective and quick.

  • Accurate disease classification (test-based).

  • Ideal for infectious diseases.


#🔹 Limitations

  • Depends heavily on accuracy of diagnostic tests.

  • Misclassification possible if test sensitivity/specificity is low.

  • Not suitable for non-infectious or chronic diseases.


#Must-Remember for Exams

  • ✔ It is a case–control study

  • Cases = Test positive

  • Controls = Test negative

  • ✔ Measure = Odds Ratio

  • ✔ Commonly used for vaccine effectiveness studies


#🧠 One-Line Memory Trick

“Same symptoms, same hospital, different test results.”