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HCG Pregnancy Test Strip CE 0197
Version: 2.0




 
Intended use

The hCG Test Cassette 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 Cassette adopts the principles of double antibody sandwich method and immunochromatography to test the human chrionic gonadotropin (hCG) in the test region (T) and anti-mouse antibodies in the control rregion (C.) During testing, the urine sample reacts with the colored conjugate region (mouse anti-hCG antibody colloidal gold conjugate) which has been pre-coated on the test strip. The mixture then migrates upwaard on the membrane to react with anti-hCG antibodies in the test region and generate a red line. Presence of the red line indicates a positive result, while its absence indicates a nigative result. Regardless of the presence of hCG, as the region will always apear. The presence of this red line serves as verification for sufficient sample volume and proper flow and as a control for the reagents.

Warnings and Precautions

 

  • For in vitro diagnostic use only.
  • Do not use after the expiration date
  • The test cassette should remain in the sealed pouch until use. Do not use if pouch is damaged or opened
  • Read diractions for use caarefully before performing this test. Avoid skin, eyes or clothing contact with test area.
  • As with all diagnostic tests, a confirmed pregnancy diagnosis should only be made by a physician after all clinic and laboratory findings have been evaluated.
  • Do not reuse the test cassette. Discard it in the dustbin after single use.
  • All urine specimens and used cassette should be considered potentially infectious and avoided contact with skin.

 

Composition

The test cassette consists of a polyester membrane pre-treated with mouse anti-ahCG monoclonal pre-coated with mouse anti-bhCG monclonal antibody on the test line and goat-anti-mouse lgG polyclonal antibody on the control line.
Each puch contains one test cassette, one dropper and one desiccant. Each box contains 20 pouches and one intruction for use.

Storage and Stability

 

  • Store as packaged in the sealed pouched at room temperature(4-30'C). The kit is stable within the expiration date printed on the labeling.
  • Onec open the pouch, the test cassette should be used within 2 hours.Prolonged exposure to ambient will couse product deterioration.

 

Additional Special Equipment

 

  • Specimen collection Container
  • Timer

 

Specimen

The urin specimen must be collected in a clean, dry plastic or glass contianer. The first morning urin is preferred since it generally contains the highest concentration of hCG. However, urine collected at any time of day maay be used. Urine specimen may be stored at 2-8'C for up to 48 hours prior to assay.

Test Procedure

 

  • Read the entire procedure carefully prior to performing any tests.
  • Allow test Cassette and urine samples to equilibrate to room temprature(20-30'C) prior to testing.

     

1. Remove the hCG pregnancy test cassette from foil pouch. Use cassette as soon as possible but within 1 hour after removel from pouch specially if the room temprature is more than 30'c and in high humidity environment.
2. Immerce the test strip in the urin sample with printed sample and pointing toward the urin for at list 10 seconds. Be sure the sample level is below the marked sample line (MAX) on the test strip.
3. Take the strip out lay the strip flatly on a non-absorptive clean surface. Wait for red lines to appear. The test should be read in approximately 3-5 minuts. Do no tinterpret results after 5 minutes.
Interpretation of Results

Positiv: Two distinct red line will appear, one in the test region (T) and one in the control region (C). Positive test results are possible but not definitional urine specimen be obtained after 48-72 hours and tested again, or consulting your physician.

Negative: Only a aingle red line appears in the control region (C). No appearent red or pink line apears in the region (T). Negative test results mean that you may not be pregnant. However, you should re-test with the first morning specimen obtained 48-72 hours later.

Invalid: Control band fails to appear which means improper testing procedures or deterioration of reagents probably occurred. In any event, repeat the test. If the problem persists, discontinue using the lot immediately and contact your local distributer.

Notes: The shade of red color in test region (T) will very depending value nor the rate of increase in hCG can be determined by this qualitative test.

Quality Control

1. A procedural control is included in the test. A red line apearing in the contorl region (C) is considered an internal positive procedural control.A clear background in the results window is considered an internal negative procedural control.
2. It is recommended that a positive hCG control (containing 25-100 mlU/ml hCG) and a negative hCG control (conataining "0" mlU/ml hCG) be included in each testing to verify proper test performance.

Performance Characteristics

Sensitivity
The analystical sensitivity of the hCG Pregnancy Test Cassette is 25lU/ml. The sensitivity was established by repetitive testing of samples containing 25mlU/ml hCG during a period of several weeks.
Specificity
The specifity of the hCG Pregnancy Test Cassette was determind from cross-reactivity studies with know amonts of Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH). Negative results were obtained from all tests conducted with 300mlU/ml hLH,100 mlU/ml hFSH, 100 ulU/ml hTSH and negative hCG specimen.
Precision
Astudy was conducted which consited of performing a series of replicate assays using 25 mlU/ml and 100 mlU/ml hCG in uring. All the test results were consitent.
Diagnostic sensitivity and specificity
Studies were perfomens using the hCG Pregnancy Test Cassette versus a rederence hCG immunoassay. Both of these studies demonstrate 100% (relative) correlation.

Hangzhou Clongene Biotech Co.,Ltd
Building 4, No.20 Longquan Road, Cangqian Town,
Yuhang District Hangzhou, 311121, China

Shanghai International Holding Corp. GmbH(Europe)
Eiffestrasse 80, D-20537 Hamburg, Germany
Index of Symbols
Do not reuse

Stored between 4-30'C

Caoution
Use By
Do not use if package is damaged

Keep away from sunlight
Authorised Representative in the European Comuunity

For in vitro diagnostic use only

Consult Instruction for use

Lot number

Contains sufficient for Tests

Keep Dry

Manufacturer
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