Top> human IVD> CICONIA "HCG"

 

Overview

The product name "CICONIA" is derived from the genus name of the European white stork which is well known for its symbolic association with baby births.
The CICONIA “HCG” is a one-step chromatographic immunoassay for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test utilizes a combination of antibodies including a monoclonal antibody to selectively identify hCG and a polyclonal antibody labeled with colloidal gold. Method of test procedure is very easy and simple compared with RIA, EIA, or HAIR. The results can be determined visually by naked eyes in minutes to indicate a positive or negative result for pregnancy.

Characteristics

REAL ONE STEP

Just immerse the Test Strip in a urine specimen.

HIGHLY SENSITIVE (detection range)

hCG 25 IU/L to 1 x 10⁶ IU/L.

HIGHLY SPECIFIC

No cross reaction with hLH, hFSH, hTSH.

RAPID

Test can be completed within few minutes.

Test Principle

Urine applied to the Urine Sampling Pad reacts with Antibody­A (Ab-A). If urine contains enough amount of hCG 　(Antigen: Ag), ”Ag­Ab·A“ complex is formed. Then, the complex migrates toward the Test Window where Antibody­B 　(Ab-B) is impregnated, and the complex is caught by the Ab·B. Excess Ab·A and/or ”Ag­Ab·A“ complex migrate to the Control Window where Anti­mouse IgG is impregnated. They are grasped by Anti­mouse IgG at the Control Window.

As the result, a magenta line appears in the Test Window and the Control Window. If the hCG content in the urine is insufficient and/or is not present, only one magenta line appears in the Control Window, but no apparent line in the Test Window.

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Contents

CICONIA"HCG" (Real One Step Pregnancy Test )

Contents	Size	Ingredients
Test Strip	50 pieces / box	­ Anti­hCG monoclonal antibody (mouse) ­ Anti­hCG polyclonal antibody (mouse) labeled with colloidal gold ­ Anti­mouse IgG polyclonal antibody (goat)

Storage and Shelf-Life

Store at room temperature (2 to 30°C) avoiding direct sunlight.
Expiration date is indicated on the package.

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Test Procedure

1. ollect a urine sample in a clean cup.
2. Remove the Test Strip from the aluminum pouch. Do not open the aluminum pouch until just before use.
   
3. Immerse the Strip into urine for 3 seconds with the arrow end pointing towards the urine. Do not immerse past the maximum line.
   
   
4. Place the Strip on a flat surface with the windows facing up. Do not place on an absorptive surface such as tissue paper.
   
5. Wait for a colored band appears in the Control Window to read the result.

Interpretation of Results

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Performance Characteristics

Sensitivity (Detection range)

hCG (IU/L)	0	25	50	100	500	1x 106
Result	-	+	+	+	+	+

Specificity

hLH (IU/L)	1000
Result	-

hFSH (IU/L)	1000
Result	-

hTSH (mIU/L)	1000
Result	-

Reproducibility

The same results were obtained from three assays with the same sample.

Interfering Substances

1. The following substances did not interfere the expected test results.
   

   Substances	Concentration
   Acetaminophen  Ascorbic acid  Ascorbate  Atropine  Caffeine  Salicylic acid  Phenylpropanolamine  Urea  Glucose  Albumin (human)	200 mg/dL  80 mg/dL  400 mg/dL  50 mg/dL  20 mg/dL  75 mg/dL  150 mg/dL  2 g/dL  4 g/dL  5 g/dL

2. Test results were not interfered by urine samples in the pH range of 4.5 to 9.0.

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Precautions

Patient

• False-positive results may be observed in patients with the following symptoms. The results must be evaluated by a physician before diagnosing pregnancy.
  *Post partus, threatened abortion, artificial abortion, chorionic epithelioma, treatment with gonadotropin, etc.
• False-negative results may be observed in patients with extra-uterine pregnancies or at very early stage of pregnancy. The results must be evaluated by a physician before diagnosing pregnancy.
• In case of an unclear result or a faint line, repeat the test after a few days with a new device and fresh sample.

Urine specimen

• Collect urine in a clean cup and perform test promptly.
• Do not use serum or other body fluid.
• Highly contaminated urine with blood, pus, or other foreign substances may cause incorrect results.

Test procedure

• Perform the test correctly in accordance with the instructions at room temperature avoiding the direct sunlight.
• Do not open the aluminum pouch until just before use.
• Do not touch the Urine Sampling Pad.
• Immerse the Test Strip into urine for 3 seconds with the arrow end pointing towards the urine.
  Do not immerse past the maximum line.
• Interpret the result within 20 minutes after the appearance of the control line.

 

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