World of Health Biotech Co., Ltd.
Main products:one step rapid test kits,one step L H rapid test kits,one step drug of abuse test kits,one step HIV rapid test kits,one step HBSAG rapid test kits
Contact Us
  • Contact Person : Mr. Cui Kai
  • Company Name : World of Health Biotech Co., Ltd.
  • Tel : 86-10-66179934
  • Fax : 86-10-66503718
  • Address : Beijing,Beijing,216#No.66 Qianbanbijie,Xinjiekou,Xicheng,Beijing.China
  • Country/Region : China
  • Zip : 100035

Pregnancy test midstream HCG midstream CE Approved

Pregnancy test midstream HCG midstream CE Approved
Product Detailed
Pregnancy HCG tests 1.Qualitative results in 1-5 minutes 2.Sensitivity: 10~25mIU 3.Up to 99% accuracy 4.CE approved


 1.0    Name of kit:     WOHBC One-Step LH Test – Midstream  2.0    Indication:    For In Vitro Detection of  Ovulation  3.0    Package Size:  One test per kit  4.0    Active Ingredients: 4.1 Coated Antibodies: 4.1.1  Control region: Goat anti-mouse(IgG) polyclonal antibody 4.1.2  Test region: Mouse monoclonal anti-LH antibody A 4.2 Labeled Antibodies: Colloidal gold conjugate of monoclonal anti-LH antibody  B


  Assay Protocol: 5.1 Assay Procedure: Read the package insert for  WOHBC One-Step LH test carefully before starting the assay. Allow urine samples to warm up to room temperature before testing. 5.1.1  To begin testing, open the sealed pouch by tearing along the notch. Remove test kit from the pouch and use it as soon as possible. 5.1.2  Hold the handle of the test with one hand. Use the other hand to remove the cap and expose the absorbent sampler.    Put the cap aside for now.. 5.1.3  Point the absorbent tip downward; place the absorbent tip in urine stream for at least 10 seconds to be thoroughly wet. Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 10 seconds. 5.1.4  Re-cap the device and wait for color bands to appear. Depending on the concentration of hCG in the test specimen, strong positive result may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (10 minutes) is required. It is important that the background is clear before the read is read.    Do not read results after 30 minutes. 5.2  Interpretation of Results: 5.2.1  No LH Surge: Only one color band appears on the control region or two bands appear and the test band is lighter than the control band. This indicates there is no LH surge. 5.2.2  LH Surge: Two color bands are visible and the test band is equal to or darker than the control band, one will probably ovulate in the next 24-48 hours. If one wants to be pregnant, the best time to conceive is after 24 but before 48 hours. 5.2.3  Invalid: No visible band at all. Repeat test with a new test kit.  6.0    Cut off Value:   20 mIU/mL LH in urine sample.  7.0    Specificity: 7.1 Cross Reactivity The cross reactivity of LH test kits was evaluated with LH homologous hormones. Homologoushormones FSH and TSH were added to urine samples containing LH at concentration of 0, 30or 100 mIU/mL. No cross reactivity was observed in the study (shown as Table 1).  7.2 Non-specific interference One-step LH test was checked for possible interference from visibly hemolyzed, lipemic and icteric samples. Human hemoglobin, bilirubin or albumin was spiked into samples with differentconcentration of LH and tested using un-spiked sample as controls. No significant interference was observed in 20 sample testing results that were either positive or negative for LH. The results are shown as Table 2.  

 8.0    Storage:  2 to 30°C                                            9.0    Expiration Dating:   24 months from date of manufacture  10.0   Method of Manufacture: 10.1     Nitrocellulose Membrane Manufacture: 10.1.1  The purified monoclonal antibody, diluted in phosphate buffer saline, is coated on the test region. Simultaneously, goat anti- mouse IgG polyclonal antibody, diluted in phosphate buffer saline, is coated on the control region.  

10.1.2  The coated membrane is dried for a minimum of 24 hours then sealed in an aluminum bag which contains silica gel desiccant. 10.2        Anti-LH colloidal gold conjugate pad manufacture: 10.2.1  A buffer solution containing mouse Anti-LH monoclonal antibody/colloidal gold conjugate is coated onto non-woven cloth sheets. 10.2.2  The coated non-woven cloth is dried for minimum 24 hours then sealed in an aluminum bag which contains desiccant. 10.3     Test Device Assembly: 10.3.1  The coated membrane S1, the conjugate pad S4, and an absorbent pad are applied to an adhesive-coated backing. 10.3.2  A 2-part waterproof label is applied over the conjugate pad and the absorbent pad, the assembled sheet of material is cut into strips. The test strips are then vacuum-dried for a minimum of 4 hours.

10.3.3  The assembled strip is placed in a plastic cassette casing. 10.3.4  The assembled cassette is sealed in an aluminum pouch along with a desiccant packet.  11.0    Clinical Trials: To establish the sensitivity and specificity of WOHBC One-step LH test kit relative to other qualitative urine LH tests. 425 clinical samples were studied. The overall accuracy of WOHBC One-Step LH test kit in this study was 100%. Another commercially qualitative test kit (ABI LH) was used to compare with WOHBC One-Step LH test kit for relative sensitivity and specificity in 803 urine samples. In total, 8 samples were discordant, meaning the agreement rate is 99.0%. The detailed results are shown in Table 3.   12.0    Stability Studies: It is well known that immunochemicals are quite stable at room temperature if the materials are kept in dry condition. The chemicals used in the One-Step LH device are either dried on the membrane or chemical pad. The final test device is then sealed in an aluminum pouch with a desiccant. To establish the shelf-life and to predict the expiration date of the test, accelerated stability testing has been carried out in this study.  Three lots of One-Step LH test kit have been used for this study. The test devices in aluminum pouches were kept in the incubator at 42°C or room temperature. The test kits were removed from their storage and tested with positive and negative control panels. The results are shown in Table 4 and 5.   The data collected to date indicate that WOHBC Inc’s One-Step LH test kits is stable for at least 24 months 2-30°C. 

Pregnancy test midstream HCG midstream CE Approved

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