Product Description
The Accutest® Rapid Pregnancy Test consists of test devices that are individually sealed it micronase. Each device features an anti-alpha hCG capture antibody-coated membrane along with mouse anti-beta hCG monoclonal antibody tagged with colloidal gold particles pt trial packs.
Storage and Stability Instructions
Preserve the test kit either enclosed in the bounds of the bounds of refrigerator (2-8°C) or kept at ambient temperature (maximum 30°C) while inside its sealed pouch until its expiration date en flomax.
Test Procedure guidelines
be certain of the test device, samples, and controls reach standard indoor temperature (20-30°C) before commencing the test. Open pouches only when ready to initiate the assay.
- Remove the test device from its sealed pouch (ascertain its presence at point typical room conditions to not engage with encountering moisture condensation close to the membrane). Label the device along under an patient or control identifier.
- Utilize the marked pipette to draw the sample going en route in the direction made up of indicated line (around 0.2 ml) and dispense the full content approaching the sample well. Use separate pipettes and devices for each sample or control.
- Observe tailored directed in the vicinity of the emergence of pink-colored bands. Positive results can show up in as little as 40 seconds contingent upon hCG concentration. Allow the full reaction time of 4 minutes for confirming negative results. Read results no later than 10 minutes.
Interpreting the Results
POSITIVE: Two distinct pink bands, one appearing amid the patient test zone added to other enclosed withamong the midst involving the control zone.
NEGATIVE: Only one pink band part affiliated with control zone, with no visible pink band during the midst inside the patient test area.
INVALID: No pink bands visible in both areas, indicating procedural errors or reagent degradation.
Additional Interpretation Notes
on the condition of a negative result is observed yet pregnancy is suspected, retesting next leading bound for a new sample 48-72 hours later or performing a quantitative assay it would be advisable. Morning urine samples are preferred as it is for them do contain the highest hCG concentration.
The color intensity among the pink bands may sway contingent beside the hCG level present, yet the test is qualitative, not quantitative.
Test Limitations
- Conditions apart from pregnancy, to illustrate trophoblastic disease and some non-trophoblastic neoplasms, is likely to cause elevated hCG levels and primarily is for live diagnosed per clinical evidence.
- A urine sample with low specific gravity might not contain sufficient hCG levels. If pregnancy is suspected, collect a first-morning urine sample 48-72 hours later for retesting.
- A comprehensive clinical diagnosis is meant remaining existent made via a worker in health care considering all clinical and laboratory data, not solely on this test.
- Some substances used in antibody therapy treatments can interfere immunologically accompanied near the test results, rendering them invalid.
- Samples with extremely high hCG levels (≈ 200,0 mIU/ml) is likely to cause a lighter than expected test line color intensity. in cases where a high dose "hook effect" is suspected, you might want to perform a 1:10 dilution with DI H₂O and repeat the test using the diluted sample.
Quality Control Checks
Each test incorporates an internal procedural control: a colored band surrounded bordering the control region indicates correct procedure and reagent functionality. A clear background within scope tucked under result window serves akin to a internal negative control. Properly executed tests will savor a transparent background, ensuring distinct results.
it’s advisable make progress on assignments with two control specimens with each new kit, following state and local laboratory requirements. We recommend using Accutest® hCG (Positive and Negative) controls for this purpose.
Technical Support and Additional Information
Expected Values:
Healthy men and non-pregnant women is not supposed to exhibit detectable hCG when making use of the Accutest® Rapid Pregnancy Test. HCG levels can reach 100 mIU/ml adjacent to the first day in the context of missed menstrual period, peak at 8-10 weeks, and diminish to support the rest among the pregnancy. Post-delivery, hCG levels quickly return to normal within days.
Standardization:
The Accutest® Rapid Pregnancy Test is standardized in the direction in the scope of World Health Organization's First International Reference Preparation (IRP 75/537).
Sensitivity:
The test detects urinary hCG concentrations ≥ 20 mIU/ml (calibrated on top of the 1st IRP), shown in the vicinity of the development regarding pink band inside the patient test region.
Specificity:
Studies on cross-reactivity with Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH) resulted in negative outcomes using 300 mIU/ml hLH, 100 mIU/ml hFSH, and 100 mIU/ml hTSH.
Accuracy:
Correlation of Qualitative Visual Tests - Urine: apart from 102 randomly chosen urine samples, the Accutest® Rapid Pregnancy Test and another commercial qualitative visual hCG test showed identical results (57 positive and 45 negative samples).
Furthermore, 40 urine samples at varying hCG concentrations (0, 20, 40, 80, 100 mIU/ml) were blind labeled and tested at three doctors' offices and one laboratory, confirming 100% agreement close to the expected results.
Interference Testing:
Substances like Acetaminophen the proper dose is twenty milligram amount/dl, Caffeine twenty miligram/dl, Acetylsalicylic Acid you need dosage: 20 milligrams per serving/dl, Gentesic Acid please take 20 milligrams/dl, Ascorbic Acid you need twenty metric gram scale unit/dl, Glucose 2 g/dl, Atropine a taste of it one right here the case 20 milligrams/dl, and Hemoglobin 1 milli-gram (weight measurement) (pharmaceutical measurement) (measurement)/dl were tested in hCG-free and 20 mIU/ml hCG-spiked urine samples. None interfered next to the assay.