HCG One Step Pregnancy Test Device (Serum/Urine)
KIT COMPONENTS
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● Test device
● Dropper
● Package insert
SAMPLE COLLECTION AND PREPARATION
Plasma
Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
Separate the plasma by centrifugation.
Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks.
Plasma may be frozen at -20°C for up to one year.
Serum
Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
Allow the blood to clot.
Separate the serum by centrifugation.
Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.
Urine
Urinate into a clean, dry cup or container.
PERFORMANCE CHARACTERISTICS
Accuracy
A multi-center clinical evaluation was conducted comparing the results obtained using the hCG
One Step Pregnancy Combo Test Device (Urine/Serum) to another commercially available urine membrane hCG test. The study included 150 urine specimens, and both assays identified 72
negative and 78 positive results. The results demonstrated >99% overall accuracy of the hCG One Step Pregnancy Combo Test Device (Urine/Serum) when compared to the other urine membrane hCG test.
Sensiticity and Specifity
The hCG One Step Pregnancy Combo Test Device (Urine/Serum) detects hCG at a concentration of 25mIU/mL or greater. The test has been standardized to the W.H.O. International Standard. The addition of LH (500mIU/mL), FSH (1,000mIU/mL), and TSH (1,000µIU/mL) to negative (0mIU/mL hCG) and positive (25mIU/mL hCG) specimens showed no cross-reactivity.
Interfering Substances
The following potentially interfering substances were added to hCG negative and positive specimens.
Acetaminophen 20 mg/dL Caffeine 20 mg/dL
Acetylsalicylic Acid 20 mg/dL Gentisic Acid 20 mg/dL
Ascorbic Acid 20 mg/dL Glucose 2 g/dL
Atropine 20 mg/dL Hemoglobin 1 mg/dL
Bilirubin 2 mg/dL
None of the substances at the concentration tested interfered in the assay.