Principle
The HCG Pregnancy Test Strip utilizes a combination of antibodies including a
monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay
is conducted by immersing the test in a urine specimen and observing the formation
of red-colored lines. The specimen migrates via capillary action along the
membrane to react with the colored conjugate. Positive specimens react with the
specific antibody-HCG-colored conjugate and form a red colored line at the test line
region of the membrane. The absence of this red colored line suggests a negative
result. To serve as a procedural control, a red colored line will always appear in the
control line region if the test has been performed properly.
Warnings and Precautions
1. For in vitro diagnostic use only.
2. Do not use test kit beyond the expiry date.
3. The test device should not be reused.
4. The test strip should remain in the sealed pouch until use. Do not use if the
pouch is damaged or opened.
5. Urine specimens may be infectious; ensure proper handling and dispose of all
used reaction devices into a biohazard container.
Precision
A study was conducted which consisted of performing a series of replicate assays
using 10 mIU/ml and 100mIU/ml HCG in urine. All the test results were consistent.
Diagnostic sensitivity and specificity
Studies were performed which consisted of testing 126 positive and 177 negative
specimens using the HCG Pregnancy Test Strip versus a reference HCG
immunoassay. Both of these studies demonstrate 100% (relative) correlation.
Index of Symbols
Manufacturer: Guangzhou MicroTUS International Biotechnology Co., LTD.
Address: NO.18 Huajun Chuang Yi Yuan Creative Industry,
Baiyun District, Guangzhou China
Tel/Fax: +860229037812
http://www.mtusbio.com
info@mtusbio.com
