HCG Pregnancy Rapid Test Strip

1. CE 0197 Mark. 2. For self-testing and in vitro diagnostic use only. 3. Convenient for use 4. OEM available

HCG PREGNANCY TEST

Catalog No.	Product Name	Specimen	Note
ABT-FT-A1	HCG Urine Strip	Urine	CE 0197
ABT-FT-B1	HCG Urine Cassette	Urine	CE 0197
ABT-FT-C1	HCG Urine Midstream	Urine	CE 0197
ABT-FT-A2	HCG Urine/Serum Strip	Urine/Serum
ABT-FT-B2	HCG Urine/Serum Cassette	Urine/Serum

INTENDED USEAccu-Tell® One Step hCG Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. 

SPECIMEN COLLECTION AND PREPARATION

COLLECTION 

A urine specimen must be collected in clean dry container.

Collect urine specimens in clean containers.

First morning specimens generally contain the highest concentrations of hCG and are recommended for early detection of pregnancy. However, any urine specimen is suitable for testing.

PREPARATION

Specimens may be kept at room temperature for 8 hours or stored at 2-8°c for up to 3 days. For prolonged storage, specimens may be frozen and stored below -20°c. Frozen specimens should be thawed and mixed before testing.

TEST PROCEDURE

Allow the test device, Urine specimen and/or controls to equilibrate to room temperature(15-30°c) prior to testing.

(1) Remove the test device form the sealed pouch and use it as soon as possible.

(2) With arrows pointing toward the urine specimen, immerse the strip test vertically in the urine specimen, for at least 5 seconds. Do not pass the maximum line (max) onthe strip test when immersing the strip.

(3) Lay the strip flatly on a non-absorbent clean surface. Start the timmer and wait for the red line(s) to appear. Read result within 5 minutes but no longer than 15 minutes.

INTERPRETATION OF RESULTS

NEGATIVE: One red-purple colored line in the control region(C). No appearnt red or pink line appears in the test region(T).

POSITIVE: Two red-purple colored lines appear. One line should be in the control region(C) and the other line should be in the test region(T).

INVALID: Control line fails to appear. Review the procedure and repeat the test with a new test strip. If the problem persists. Discontinue using the test kit immediately and contact your local distributor.

Notes: The intensity of the red color in the test line region(T) will vary depending on the concentration of hCG present in the specimen. However, neither the quantitative value nor the rate of increase in hCG can be determined by this qualitative test.

PERFORMANCE CHARACTERISTICSSensitivity and SpecificityThe Accu-Tell® One Step hCG Pregnancy detects hCG at a concentration of 25mlU/mL or greater. 300 know negative urine samples were equally divided into 6 groups.Each group of samples(50) were spiked with HCG to the concentration of 0mlU/ml, 10 mlU/ml, 15 mlU/ml, 25 mlU/ml, 50 mlU/ml and 5 IU/ml separately, calibration against WHO 3rd international standard. Each group of sample of samples were tested with Accu-Tell® One Step hCG Pregnancy Test. The results from this study gave 100% agreement with the expected results.

Result	0mlU/ml	10mlU/ml	15mlU/ml	25mlU/ml	50mlU/ml	5lU/ml	Total
Positive	0	0	0	50	50	50	150
Negative	50	50	50	0	0	0	150
Total	50	50	50	50	50	50	300

Interference TestingAccu-Tell® One Step hCG Pregnancy Test has been tested with commonly known drugs and hormones including LH(500mlU/ml),FSH(1,000mlU/ml),and TSH(1,000μlU/mL).At the levels tested, none of these substances interfered with the expected test results. For example: Acetaminophen 20mg/dl,Ace-tylsalicylic Acid 20mg/dl, Ascorbic Acid 20mg/dl,Atropine 20mg/dl,Caffeine 20mg/dl,Gentesic Acid 20mg/dl,Glucose2g/dl,Hemoglobin 20mg/dl, Ampicillin 20mg/dl,Tetracycline 20mg/dl.

Storage and StabilityThe test kit can be Stored at 4-30°C in the sealed pouch. It is stable through the expiration date printed on the pouch lable. Do not freeze.

ABOUT US

we have exported our in vitro rapid diagnostic test and lab equipment to over 50 countries.

 Our Aim:

——Let every family benefit from our convenient and reliable diagnostic products and services.

——Let our lab equipment be used in every laboratory of the world.

 Our Values on Quality:

——Delivers customer value in all in all projects, services and processes;

——Gives quality at least as much consideration as schedules and budgets when day-to-day choices need to be made;

——Drives QMS results to the bottom line in terms of defect reduction and financial benefits;

——Allocates resources to achieve quality execution.

 

Our product have got CE0197 approved, ISO13485 & ISO9001 certification.

If you need high quality product at competitive price, good after-sale service, good supply chain —— Please contact us without hesitation or visit our website at www.accubiotech.com

HCG Pregnancy Rapid Test Strip