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HCG Latex Agglutination Test - hCGTEST
The placental hormone, Human Chorionic Gonadotropin (hCG) appears in the urine of pregnancy females MBDr Direct hCG is designed for use after a missed menses, with urine samples for the detection of normal pregnancy. As a Latex Direct agglutination test MBDr Direct hCG will detect hCG at the level of 0.3 International Units per milliliter. This level of concentration may be found as early as three days past the missed menses. If a negative result is obtained and pregnancy is still suspected, the test should be repeated in approximately seven days. The test component is a suspension of latex particles bound with antibody to hCG. The antibody bound latex will attach to the hCG found in positive urine samples causing agglutination which is observed as a clumped or lumpy appearance of the mixture. Negative samples produce no agglutination and the mixture appears smooth.
FEATURES
• Fast
• Simple
• easy to use and interpret
• no equipment needed
• no mixing and measuring
• Accurate
• Sensitivity = 0.3 lU/ml
• Built-in control
• Room temperature storage
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PROCEDURES FOR hCGTEST |
BENEFITS
• No special equipment is needed
• Results are easy to interpret
• No sample preparation
• Results in 5 minutes |
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1. Place one drop of urine specimen onto a circle of the slide using a separate disposable plastic for each urine sample.
2. Add one drop of well-shaken antibody-bound latex suspension onto the urine.
3. Stir with the disposable stirrer to spread the mixture over the entire circle.
4. Rock the slice gently for two minutes and observe for agglutination. Dry of the mixture may lead to erroneous results. The slide should be read within three minutes of the end of step four.
INTERPRETATION
Agglutination within three minutes is a positive result. No agglutination within two minutes is a negative result.
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The graph above indicates the change in concentration of hCG over the period of gestation. 522 first morning urines were collected from 240 women with normal pregnancy. The line represents average values although a wide range of values may be found one either side of the curve. |
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PERFORMANCE CHARACTERISTICS
Sensivity : the sensitivity of MBDr Direct hCG is 0.3 IU/mL. Most specimens contain levels high enough to be detected at this sensitivity approximately 3 days passed the missed menses.
APPLICATION
For detection of pregnancy.
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CONTENTS OF THE KIT
1. Antibody bound latex suspension 5ml 2. Positive urine control 1ml Contains >2.0 IU/mL & 1% Sodium Azide as preservative
3. Negative urine control 1ml Normal urine containing 0.1% Sodium Azide as preservative
4. Reaction Plate 1 each
5. Disposable Stirrers
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