Pregnancy & Fertility
Point-of-care rapid testing for pregnancy & fertility. OEM/ODM manufacturer.
Overview
Reproductive hormone tests support pregnancy detection and fertility tracking.
Clinical Context
Reproductive hormone tests support pregnancy detection and fertility tracking across retail and clinical channels.
Diagnostic Markers & Methods
hCG (pregnancy) · LH (ovulation) · FSH (menopause/fertility) · fFN and iGFBP-1 (preterm risk) · PDG.
Antigen vs Antibody
These are hormone (antigen) tests, not antibody tests.
Diagnostic Workflow
hCG for pregnancy; LH surge for ovulation timing; FSH for ovarian reserve/menopause; fFN/iGFBP-1 for preterm-risk stratification.
Testing Window
hCG: from ~day of missed period. LH surge: mid-cycle, precedes ovulation ~24–36 h.
Interpretation
hCG positive = pregnancy; LH surge predicts ovulation ~24–36h later. fFN/iGFBP-1 are risk-stratification aids, not diagnostic.
False Negative / Positive Considerations
False negative: testing before the hCG rise / LH surge. False positive: rare.
Confirmatory Testing
Quantitative hCG or ultrasound (pregnancy).
Testing Settings
Retail (hCG/LH) and clinical (FSH, fFN, iGFBP-1) use; confirmation by ultrasound or quantitative hCG.
Sources
ACOG practice guidance; NICE fertility.
Progene's Take
Position: For pregnancy/fertility, compete on packaging and private label, not on the chemistry — hCG and LH are commodity tests, so retail differentiation is the moat.
- hCG/LH/FSH are high-volume, low-complexity — buyers choose on price, brand and packaging.
- Private-label retail packaging is the margin lever.
- fFN/iGFBP-1 are risk-stratification aids, not diagnostics — label them accordingly.
This is the buyer-advisor view of the technical team — editorial guidance, not a substitute for product IFU or local regulatory requirements.
Frequently Asked Questions
How early can a pregnancy test detect hCG?
Many tests detect hCG around the first day of a missed period (20–25 mIU/mL sensitivity); testing too early can give a false negative.
When is the best time to test for the LH surge?
Mid-cycle, testing daily in the afternoon/evening; the LH surge precedes ovulation by ~24–36 hours.
Can fFN or IGFBP-1 diagnose preterm labor?
No — they are risk-stratification aids used with clinical findings and gestational age, not standalone diagnostics.
Related knowledge
Products (5)
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