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PREQUALIFICATION DOCUMENTS (ANTI HCV ANTIBODIES & HEPATITIS B SURFACE ANTIGEN (HBsAg) RAPID DIAGNOSTIC TESTING KITS/DEVICES FOR HEPATITIS & INFECTION CONTROL PROGRAM)(MANUFACTURING UNITS AND SOLE
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01
Open the rapid test kit and make sure all components are present and in good condition.
02
Read the instructions carefully before starting the test.
03
Collect the sample as per the instructions provided - it could be blood, urine, or oral swab.
04
Use the provided dropper to place the sample on the test strip.
05
Wait for the specified amount of time for the test results to appear.
06
Read and interpret the results as per the guidelines provided in the instructions.
07
Dispose of the test kit and sample collection materials properly.

Who needs performance of rapid tests?

01
Individuals looking for quick and easy testing for certain diseases or conditions.
02
Healthcare professionals conducting rapid screening in clinics or hospitals.
03
Employers or organizations implementing regular testing protocols for their employees or members.
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The performance of rapid tests refers to their effectiveness in accurately detecting the presence or absence of specific conditions or pathogens within a short time, usually with high sensitivity and specificity.
Manufacturers and distributors of rapid tests are required to file performance data, especially those seeking approval or clearance from regulatory authorities.
To fill out the performance data, one must follow the guidelines provided by regulatory agencies, including specific metrics like sensitivity, specificity, and validation results, often using designated forms or electronic submissions.
The purpose is to ensure that rapid tests provide accurate and reliable results, which are crucial for effective diagnosis and treatment in clinical settings.
Key information includes the test's sensitivity, specificity, accuracy, sample size, and any conditions affecting performance, along with statistical validation results.
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