Infectious Disease
S. pneumoniae Antigen Rapid Test
Detects Streptococcus pneumoniae antigen. colloidal-gold. Specimen: Urine.
| Target / Analyte | Streptococcus pneumoniae antigen |
|---|---|
| Disease / Indication | Pneumococcal pneumonia |
| Series | Infectious Disease |
| Method | colloidal-gold |
| Specimen | Urine |
| Test time | 10–15 min (product-specific) |
| Storage | 2–30 °C, sealed pouch with desiccant |
| Shelf life | 24 months (product-specific) |
| Regulatory | Non-CE / registration in progress |
| OEM/ODM | Available — private label & custom panel |
Direct Answer
This rapid test detects Streptococcus pneumoniae antigen in Urine to support Pneumococcal pneumonia. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.
Intended Use
Qualitative detection of Streptococcus pneumoniae antigen.
Clinical Context
S. pneumoniae urinary antigen supports pneumococcal pneumonia diagnosis.
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
Antigen detection is a supportive aid.
Procurement
Specimen: Urine. Format: cassette. CE-marked line.
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 rapid test does not always exclude infection — timing, specimen and pathogen load all matter. Follow up clinically where suspicion is high.
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 |
|---|---|---|---|---|---|
| IHP-601 | H. pylori Antigen Rapid Test Dipstick | Feces | Dipstick | 25 T | CE |
| IHP-602 | H. pylori Antigen Rapid Test Cassette | Feces | Cassette | 25 T | CE |
| IHP-602H | H. pylori Antigen Rapid Test Cassette | Feces | Cassette | 1 T | CE0123 |
| ISTY-602 | Salmonella Typhi Antigen Rapid Test Cassette | Feces | Cassette | 25 T | CE |
| IHIG-402 | HIV p24 Antigen Rapid test Cassette +1 variants | WB/S/P | Cassette | 40 T | Non-CE |
| IMP-502 | Mycoplasma pneumoniae Antigen Rapid Test Cassette | Swab | Cassette | 20 T | CE |
| IMPM-402 | Mycoplasma Pneumoniae IgM Rapid Test Cassette | WB/S/P | Cassette | 40T | CE |
| IMP-425 | Mycoplasma Pneumoniae IgG/IgM Combo Rapid Test Cassette | WB/S/P | Cassette | 25 T | CE |
| IAD-502 | Adenovirus pneumoniae Antigen Rapid Test Cassette | Swab | Cassette | 20 T | CE |
| ISP-102 | Streptococcus pneumoniae Antigen Rapid Test Cassette | Urine | Cassette | 10 T | CE |
| ISLC-125 | Legionella pneumophila and Streptococcus pneumoniae Rapid Test Cassette | Urine | Cassette | 10 T | CE |
| IBA-402 | Brucella Abortus Antigen Rapid Test Cassette | WB/S/P | Cassette | 25 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