Overview inside the Product
The Rapid Pregnancy Test Kit includes test devices that are individually sealed it kamagra. Each contains a membrane that is coated with anti-alpha hCG capture antibodies and colloidal gold particles pre-coated with mouse anti-beta hCG monoclonal antibodies fr spiriva.
reference for Storage and Stability
Maintain the test kit within its original sealed pouch and store it either refrigerated (2-8°C) or beyond the standard indoor temperature (in the depths of the bounds of 30°C) over its indicated shelf-life fr metaglip.
blueprint for Test Procedure
verify the test device, samples, and controls are left in the vicinity of the usual normal indoor air temperature (20-30°C) before usage. steer clear of that open the pouches prematurely.
To initiate testing, remove the test device from its pouch and allow it to reach consistent indoor climate. This prevents moisture from condensing amidst the membrane. Properly label the device for identification.
Use a pipette to fill up adjoining the way till the indicated line (about 0.2 ml) and dispense the specimen towards the midst designated well. Each specimen requires a separate pipette and device.
Observe directed beyond the appearance of pink-colored bands. Positive results there's a possibility detected within 40 seconds contingent upon hCG concentration levels. Confirm negative results after the full 4-minute reaction time. neglect that option interpret any results past 10 minutes.
Interpretation of Results
POSITIVE: Two distinct pink bands appear – one in relation bound geared towards the test region and one among the control region.
NEGATIVE: a distinct item pink band appears inside the control region without any band inside the test region.
INVALID: No pink bands appear, indicating a procedural error or reagent deterioration.
Important Interpretation Notes
Negative test results should occur followed up beside a sample taken 48 to 72 hours later with change quantitative assay if pregnancy is suspected.
The first-morning urine sample is suggested as matters are has the highest concentration of hCG.
The pink band intensity can influenced adjacent to the hCG concentration, but the test is qualitative, not quantitative.
Test Limitations
Higher hCG levels may provoke from conditions other than pregnancy. These include trophoblastic diseases and some non-trophoblastic neoplasms. Other medical evidence is expected continue being considered.
Dilute urine samples unlikely to represent true hCG levels. If pregnancy is suspected, retest encompassing a first-morning specimen after 48-72 hours.
Clinical diagnosis is prohibited from depend solely on one test but on overall clinical and lab findings evaluated provided in line among a medical expert.
Substances used in antibody-based treatments has the potential to disturb test results.
Very high hCG levels (~200,0 mlU/ml) might result deep within fainter test line. Consider diluting the sample 1:10 with DI water if it's a high-dose hook effect is suspected and retest.
Procedures for Quality Control
The test has a procedural control, indicated by means pertaining to colored band part embraced by control region, which ensures proper performance and reactivity. A clear background in relation at that results window serves playing the part of internal negative procedural control.
Apply two levels of control specimens for each new kit as per state and local requirements. the implementation of hCG positive and negative controls could be advised.
Support and Comments on Technical Aspects
Expected Outcomes
Healthy males and non-pregnant women typically relinquish the idea show detectable levels of hCG in tandem adjacent to the Accutest® Rapid Pregnancy Test.
HCG levels can sometimes be around 100 mIU/ml bordering the first missed menstruation day, peaking 8-10 weeks post-last menstruation period, then declining.
Standards and Sensitivity
The test is benchmarked against the World Health Organization's First International Reference Preparation (IRP 75/537).
This test detects urinary hCG concentrations at or above 20 mIU/ml, with lower concentrations possibly also providing a positive result.
Specificity
Tests indicate no false positives for Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), or Thyroid Stimulating Hormone (hTSH) at concentrations of 300 mIU/ml hLH, 100 mIU/ml hFSH, and 100 mIU/ml hTSH, respectively.
Accuracy
Qualitative Visual Test Correlation – A study with 102 urine samples analyzed alongside a commercial qualitative visual hCG test indicated full agreement (57 positive, 45 negative samples).
Additionally, 40 urine samples with varying hCG concentrations (0, 20, 40, 80, 100 mIU/ml) were blindly tested in three doctors' offices and one lab, showing 100% agreement with expected outcomes.
Interference Testing
Tests showed no interference at established concentrations for substances for instance Acetaminophen (take twenty milligram measurement dose (milligram) scale (weight measurement) (measurement) (unit) (abbreviation) (measurement) prescribed/dl), Caffeine (twenty milligram amount/dl), Acetylsalicylic Acid (in this moment 20 milligrams/dl), Gentisic Acid (twenty milli-gram dosage/dl), Ascorbic Acid (twenty milligram amount/dl), Glucose (2 g/dl), Atropine (take dosage: 20 milligrams/dl), and Hemoglobin (1 mill gm (pharmaceutical measurement)/dl) when added to hCG-free or hCG-spiked urine samples.