What are the main forms of in-vitro diagnostic reagent test results?

What are the main forms of results for in-vitro diagnostic reagent tests?

Currently, there are three main forms of reporting results when using in-vitro diagnostic reagents for testing and analysis:

Firstly, qualitative testing: The results are either "negative" or "positive." For example, if the test shows HBsAg positive, it indicates that the patient has hepatitis B virus in their body.

Secondly, semi-quantitative testing: This mainly involves testing the titer, often used in antibody determination, such as antinuclear antibody 1∶16, which is a semi-quantitative reporting method.

Thirdly, quantitative testing: This uses specific numerical values for reporting (which is also the most frequent method on current test result forms). When looking at test result forms that use numerical values, pay attention to the units of measurement after the item. Different units of measurement will result in different data, sometimes differing by thousands of times.

When judging the changing trend of a certain target test result, do not only look at the numbers; pay attention to the units. Only when the units of measurement are the same can the results be comparable.

What are the main interfering substances that affect the qualitative testing of in-vitro diagnostic reagents?

Qualitative in-vitro diagnostic reagents (kits) only give two possible results: positive or negative (reaction or no reaction, yes or no, presence or absence, normal or abnormal), such as early pregnancy test strips.

Interfering substances can be endogenous, originating from the patient's own body, or exogenous, introduced during patient treatment, ingestion, or sample preparation. Interfering substances can affect the analysis process from multiple aspects (such as chemical and physical effects, non-specificity, cross-reactivity, etc.), leading to interference during analysis and affecting the test results of qualitative in-vitro diagnostic reagents (kits). These substances mainly include:

a. Metabolic products caused by pathological conditions, such as diabetes, multiple myeloma, and cholestatic hepatitis.

b. Compounds introduced during treatment, such as drugs (such as vitamin C), intravenous nutrition, plasma expanders, anticoagulants, etc.

c. Substances ingested by the patient, such as alcohol, drugs of abuse, nutritional supplements, various foods and beverages, etc.

d. Substances added during sample preparation, such as anticoagulants, preservatives, stabilizers, etc.

e. Contaminants inadvertently introduced during sample processing, such as those from hand cream, powdered gloves, serum separators, and collection tube stoppers, etc.

f. The sample matrix itself, such as chemical and physical properties different from ideal fresh samples.

Companies and users should not arbitrarily change the original detection system of in-vitro diagnostic reagents.