Uncut sheet for LH Rapid test
1. INTEDED USE
The LH Rapid Test Device (the "uncut sheet" format for manufacturing use) is intended for the qualitative detection of luteinizing hormone (LH) in human urine specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the prediction of ovulation time and assessment of ovarian function. It helps determine the timing of ovulation by detecting the "LH surge" — a rapid increase in LH concentration that occurs approximately 24–48 hours prior to ovulation, triggering the release of a mature egg from the ovary . The test employs a double antibody sandwich immunochromatographic assay using colloidal gold conjugation to capture LH present in the specimen.
The device provides presumptive screening results.Results should be interpreted in conjunction with patient history, menstrual cycle information, and other relevant clinical findings.
This product is intended for use by trained healthcare professionals or laboratory personne . This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | LH Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Urine |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking. |
| 2 | Use disposable pipette to pipette urine sample in disposable clean container, discard first two drops of urine, add 3 drops (approx. 100μL) of bubble-free urine sample dropwise to well of test device vertically and slowly, and start counting time. |
| 3 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
