What are the main aspects of the safety of in vitro diagnostic reagents?

In vitro diagnostic reagents are used to diagnose whether a patient or subject contains a certain infectious agent or whether a certain function of the body is normal, so the reagent itself needs to be safe and non-infectious. In order to ensure that people are not infected by positive substances when using in vitro diagnostic reagents, all materials containing infectious agents must be inactivated before they can be used. In order to protect the operator from damage, the container of each component of the kit should avoid using glass materials, try to use plastic products, and also avoid the use of metal aluminum lids, and use plastic materials instead. In the chemical reagent components, avoid the use of strong acids, strong alkaline reagents, etc.

Are all in vitro diagnostic reagents liquid?

In vitro diagnostic reagents are mainly used for in vitro detection of human samples, including reagents, kits, calibration products, quality control products and other products. In vitro diagnostic reagents are not only liquid, but also test strips and other forms.

How to judge the technical performance of in vitro diagnostic reagents?

The performance of in vitro diagnostic reagents is mainly reflected in three aspects: 1. Analytical performance: it mainly includes precision, accuracy, sensitivity, specificity, linear range or measurement range, etc., which is reflected in the fact that some technical indicators in the product specifications may not be completely consistent. 2. Diagnostic performance: the degree of sensitivity and specificity of the detected substance. 3, stability: product production date, expiration period, validity, and calibration requirements, etc.

Do in vitro diagnostic products have an expiration date?

In vitro diagnostic reagent products have an expiration date. The expiry date of in vitro diagnostic reagents refers to the expiry date that can only be achieved under the specified storage conditions and is clearly marked on the product label. The product should be used within the validity period.

What are the special requirements for in vitro diagnostic reagents for consumer use?

The in-vitro diagnostic reagents used by consumers themselves should include the evaluation of the cognitive ability of the product instructions by consumers without medical background in clinical trials.

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