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Human Chorionic Gonadotropin (HCG) Pregnancy Test Strip Manual

2018-03-01 10:17:37

Human Chorionic Gonadotropin (HCG) Pregnancy Test Strip  SL-CE-01

Intended Use

The HCG Pregnancy Test Strip is a rapid, one step test for the qualitative detection of human chorionic gonadotropin (HCG) in urine, as an aid for the early detection of pregnancy. The test is intended for in vitro diagnostic self-testing.

 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.

Materials provided

Reagents

Coated Antibodies: Control region, Goat anti-mouse (IgG) polyclonal antibody. Test region, Mouse monoclonal anti-HCG antibody A. 

Labeled antibody: Colloidal gold conjugate of monoclonal anti-HCG antibody B 

Storage and Stability

The test kit can be stored at temperatures between 4 to 30°C in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat. The expiration dating was established under these storage conditions.

Specimen Collection and Preparation

A fresh urine specimen should be used, no special pre-treatment is necessary. Specimens should be collected in a clean, dry glass or plastic container. The specimen may be refrigerated (2-8°C) and stored up to 48 hours.

Test Procedure

Allow the test and the specimen to equilibrate to room temperature prior to testing.

  1. To begin testing, open the sealed pouch by tearing along the notch. Remove the test kit from the pouch and use it as soon as possible.
  2. Immerse the strip vertically into the urine sample with the arrow end pointing towards the urine at least 10 seconds. Do not immerse past the “Max” Line.
  3. Take the strip out and lay the strip flat on a clean, dry, non-absorbent surface. Wait for red colored bands to appear. The test should be read in approximately 5 minutes. Do not interpret results after 5 minutes.

Results

Negative: Only one red color band appears in the control region. No apparent band in the test region.

Positive: Two distinct red color bands appear in the control and test regions. The color intensity of the test bands may vary since different stages of pregnancy have different concentrations of HCG hormone.

Invalid: No line appears in the control zone “C”, the test should be voided since an improper test procedure may have been performed or deterioration of reagents may have occurred. This is due to the internal control built in which a distinct control region (C) line should always appear. Repeat the test using a new device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Quality Control

  1. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control.
  2. It is recommended that a positive HCG control ( containing 25-100 mIU/ml HCG ) and a negative HCG control ( containing ‘0’ mIU/ml HCG ) be included in each day testing to verify proper test performance.

Performance Characteristics

Sensitivity
The analytical sensitivity of the HCG Pregnancy Test Strip is 10 mIU/ml. The sensitivity was established by repetitive testing of samples containing 10mIU/ml 

HCG during a period of several weeks.
Specificity
The specificity of the HCG Pregnancy Test Strip was determined from cross-

reactivity studies with known amounts of Luteinzing Hormone (LH). Follicle 

Stimulating Hormone(FSH), and Thyroid Stimulating Hormone (TSH). 

Negative results were obtained from all tests conducted with 500mIU/ml LH, 

1000mIU/ml FSH,1000μIU/ml TSH and negative HCG Specimen.
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.                                         

 

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