Overview affiliated with Product
Each Accutest® Instant Pregnancy Evaluation device is single-use and individually packaged de priligy. The membrane is layered with an anti-alpha hCG capture antibody, and colloidal gold particles are attached referring close toti-beta hCG mouse monoclonal antibody es skelaxin.
Storage and Stability Information
Store this test kit in its sealed pouch either inside refrigerator (2-8°C) or held close to the surrounding temperature conditions (as far as 30°C) until the expiration date pt revia.
usage directions
Allow the test device, patient samples, and control samples to reach consistent indoor climate (20-30°C) before initiation. Open pouches only when ready contributing effort with.
- Once acclimated to standard indoor temperature, remove the test device from its protective pouch. Label the device amidst the corresponding patient or control ID.
- Using the provided pipette, draw the sample up till the specified line (approximately 0.2 ml), and dispense it all to the center of test well. Ensure each sample or control has its own pipette and test device.
- Await the formation of pink-colored bands. Positive results might appear within 40 seconds, varying anchored in hCG levels. Confirm negative outcomes after 4 minutes; decline to act interpret results after 10 minutes.
result interpretation
Positive: Two pink bands emerge, one atop the center contained within patient test section and one enclosed situated surrounded at the lateral area of the control region.
Negative: an only one pink band is visible encompassed beside the midst embraced by control section with no band enclosed encompassed situated next to the patient test area.
Invalid: No pink bands appear in both regions, which could indicate a procedural error or reagent degradation.
Key Considerations for Results
If negative results are found and pregnancy is still presumed, retest paired with new sample after 48 to 72 hours or conduct a quantitative assay. First-morning urine samples are typically the acme concentrated with hCG.
The intensity enclosed in the pink band varies with hCG level, yet a qualitative test is not seen give quantitative measurements or the increment rate of hCG.
Test Limitations
- Conditions other than pregnancy, specifically trophoblastic disease and some non-trophoblastic neoplasms, may increase hCG levels. Clinical signs should guide diagnostics.
- Highly diluted urine samples (low specific gravity) might not accurately represent hCG levels. If in doubt, retest amid a first-morning urine sample collected after 48 to 72 hours.
- Results shouldn't solely determine clinical diagnoses; comprehensive evaluation executed requiring a medical specialist with all clinical and laboratory data is vital.
- Antibody-based therapies might interfere with test results.
- Specimens with high hCG levels (≈ 200,0 mlU/ml) could produce a test line with lower color intensity than expected. Suspected "hook effect" cases should have the sample diluted 1:10 with DI H₂O and retested.
Quality Control
A colored band part contained within control region verifies proper test function and reagent reactivity. A clear background before results appear serves in the position of internal negative procedural control. Ensure a clear background in order to correctly executed test.
Use two control samples with each new kit, adhering to local and state regulations. Recommended controls are Accutest® hCG (Positive and Negative).
Technical Support and Observations
Expected Values
Healthy individuals typically bypass doing proceed show detectable hCG as part of the Accutest® Instant Pregnancy Evaluation. hCG can reach 100 mIU/ml adjacent to the first missed period and peak around 8-10 weeks post-last menstrual period.
Standardization
The test is standardized till the WHO First International Reference Preparation (IRP 75/537).
Sensitivity
Detects urinary hCG levels of 20 mIU/ml or higher, with lower concentrations still potentially giving positive results.
Specificity
Studies indicate no interference with LH (300 mIU/ml), FSH (100 mIU/ml), or TSH (100 mIU/ml) at tested concentrations.
Accuracy
Comparison as part affiliated with group Qualitative Tests - Urine: 102 random urine samples showed 100% agreement with another hCG qualitative test (57 positive, 45 negative).
Blind tests of 40 urine samples with various hCG concentrations across three doctor’s offices and one lab also indicated 100% concordance.
Interference Testing
Substances for instance Acetaminophen, Caffeine, Acetylsalicylic acid, Gentisic acid, Ascorbic acid, Glucose, Atropine, and Hemoglobin did not interfere at tested concentrations.