Diagnostic kit for Luteinizing Hormone pregnanacy test Colloidal Gold
Diagnostic Kit for Luteinizing Hormone (Colloidal Gold)
Production information
| Model Number | LH | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic Kit for Luteinizing Hormone (Colloidal Gold) | Instrument classification | Class I |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Test procedure
| 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, discard first two drops of urine, add 3 drops (approx. 100μL) of bubble-free urine sample dropwise to the center of 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 result in Diagram 2). |
Intend Use
This kit is applicable to qualitative in vitro detection of luteinizing hormone (LH) level in human urine sample, and it’s applicable to prediction of ovulation time. This kit only provides luteinizing hormone (LH) level detection results, and results obtained shall be used in combination with other clinical information for analysis. This kit is for healthcare professionals.
Summary
Human luteinizing hormone (LH) is a glycoprotein hormone secreted by adenohypophysis that exists in human blood and urine, which plays the role of stimulating release of fully grown eggs from the ovary. LH is secreted dramatically and reaches LH peak in the middle of menstrual cycle, which surges from 5～20mIU/ml during basic level period to 25～200mIU/mL during peak period. Concentration of LH in urine normally rises dramatically around 36～48 hours before ovulation, which reaches peak after 14～28 hours. Follicular theca breaks around 14～28 hours after the peak and release fully grown eggs.
Feature:
• High sensitive
• result reading in 15 minutes
• Easy operation
• Factory direct price
• Do not need extra machine for result reading
Result reading
The WIZ BIOTECH reagent test will be compared with the control reagent:
| WIZ results | Test resultof reference reagent | ||
| Positive | Negative | Total | |
| Positive | 180 | 1 | 181 |
| Negative | 1 | 116 | 117 |
| Total | 181 | 117 | 298 |
Positive coincidence rate:99.45%（95%C.I. 96.94%~99.90%）
Negative coincidence rate: 99.15%（95%C.I.95.32%~99.85%）
Total coincidence rate:99.33%（95%C.I.97.59%~99.82%）
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