Women's Health
HCG Pregnancy Rapid Test
Detects Human chorionic gonadotropin. colloidal-gold. Specimen: Urine / Serum.
| Target / Analyte | Human chorionic gonadotropin |
|---|---|
| Disease / Indication | Pregnancy |
| Series | Women's Health |
| Method | colloidal-gold |
| Specimen | Urine / Serum |
| Test time | 10–15 min (product-specific) |
| Storage | 2–30 °C, sealed pouch with desiccant |
| Shelf life | 24 months (product-specific) |
| Regulatory | CE (IVDD 98/79/EC) |
| OEM/ODM | Available — private label & custom panel |
Direct Answer
This rapid test detects Human chorionic gonadotropin in Urine / Serum to support Pregnancy. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.
Intended Use
Detection of human chorionic gonadotropin (hCG) for pregnancy.
Clinical Context
hCG is the standard pregnancy hormone; rapid tests detect early pregnancy from urine or serum.
Test Principle
Colloidal-gold immunochromatography (lateral flow). The device captures the target analyte (antigen or antibody) on a membrane via labeled antibodies, producing a visible test line within minutes. Qualitative or semi-quantitative, intended as a screening/triage aid — not a replacement for confirmatory laboratory testing.
Limitations
Very early or ectopic pregnancy may give low/negative results; confirm clinically.
Procurement
Specimen: urine / serum. Format: dipstick / midstream / cassette. CE-marked line (FDA status per product on request).
Interpretation
| Result | Lines | Meaning |
|---|---|---|
| Positive | Test + control line | Target detected (presumptive positive) |
| Negative | Control line only | Below cut-off / not detected |
| Invalid | No control line | Repeat with a new device |
Common misconception
A negative pregnancy test before a missed period can be false — retest if the period is delayed.
Sources
Screening results are presumptive, not diagnostic. Confirmatory testing follows WHO, CDC and national regulatory guidance — see screening vs confirmatory.
Available SKUs (this series)
| Cat. No. | Product | Specimen | Format | Kit Size | Status |
|---|---|---|---|---|---|
| FHC-101 | Pregnancy (hCG) Rapid Test Dipstick - 2.5 +9 variants | Urine | Dipstick | 50 T, 100 T | CE/FDA |
| FHC-201 | Pregnancy (hCG) Rapid Test Dipstick +1 variants | S/P/U | Dipstick | 50 T, 100 T | CE |
| FHC-102 | Pregnancy (hCG) Rapid Test Cassette +5 variants | Urine | Cassette | 40 T | CE/FDA |
| FHC-202 | Pregnancy (hCG) Rapid Test Cassette +1 variants | S/P/U | Cassette | 40 T | CE |
| FHC-111 | Pregnancy (hCG) Rapid Test Dipstick (Canister Pack) - 2.5 +5 variants | Urine | Dipstick | 25 T | CE |
| FHC-211 | Pregnancy (hCG) Rapid Test Dipstick (Canister Pack) +1 variants | S/P/U | Dipstick | 25 T | CE |
| FHC-101H | Pregnancy (hCG) Rapid Test Dipstick +2 variants | Urine | Dipstick | 1 T | CE0123/FDA |
| FHC-102H | Pregnancy (hCG) Rapid Test Cassette +2 variants | Urine | Cassette | 1 T | CE0123/FDA |
| FHC-103 | Pregnancy (hCG) Rapid Test Midstream +2 variants | Urine | Midstream | No Box | CE/FDA |
| FHC-103H | Pregnancy (hCG) Rapid Test Midstream +2 variants | Urine | Midstream | 1 T | CE0123/FDA |
| FHC-103HI | Pregnancy (hCG) Rapid Test Midstream With Indicator +1 variants | Urine | Midstream | 1 T | CE0123 |
| FHC-402 | Pregnancy (hCG) Rapid Test Cassette +1 variants | WB/S/P | Cassette | 40 T | CE |
Technical Evidence
| Analytical performance | Sensitivity, specificity, cut-off and precision are documented per product line in the datasheet and validation report. |
|---|---|
| Average accuracy | ≥96% (overall agreement rate, manufacturer-validated). Per-product sensitivity and specificity are documented in the datasheet. |
| Clinical performance | Evaluation data (study population, reference method, agreement) available on request. |
| Cross-reactivity | Documented per analyte — see limitations above. |
| Documents | IFU · Datasheet · Certificate · Declaration of Conformity — request below. |
Buyer Information
| MOQ | Product-dependent — low MOQ available on specialty assays |
|---|---|
| OEM / private label | Custom branding, cut-off, panel and packaging |
| Samples | Available for evaluation — request via RFQ |
| Lead time | On request |
| Documents | IFU · Datasheet · COA · Validation report · CE files · Registration support |
Related knowledge
Documentation & quotation — datasheet, IFU, certificate, MOQ and OEM/ODM options on request.
Request IFU / Spec Sheet Request Datasheet Request Certificate
Last reviewed: 2026-09-12