hCG Cartridges
hCG Cartridges
The hCG Rapid Test is a qualitative, instrument-read, urine test for early detection of pregnancy. The test is performed on Smart Tester analyzers. Positive results are reported in as little as 3 minutes.
For Professional In Vitro Diagnostic Use Only.
Features
Features & Functions
SmartTester hCG rapid test kit detects hCG levels above 15 mIU/mL.
hCG Rapid Test is standardized to the World Health Organization 5th International Standard (NIBSC code: 07/364).
The hCG Rapid Test and Smart Tester analyzers are CE marked IVD 98/79EC.
| Sample Volume: | 100ul (Urine) |
| Reaction Time: | 5 minutes |
| Storage: | 1 to 30°C |
| Shelf life: | up to 24 months |
Principle of the Rapid Diagnostic Test
The test uses an anti-hCG monoclonal antibody conjugated with colloidal gold and another anti-hCG monoclonal antibody coated on the test line. When the sample has been applied to the test cartridge, the gold-labelled anti-hCG monoclonal antibody binds with the hCG in sample and forms a marked antigen-antibody complex. This complex moves then to the test cartridge detection zone by capillary action where it is captured on the test line by the other anti-hCG monoclonal antibody, resulting in a purplish red colouring on the test line.
hCG Kit Contents
Test Kit Contents
- 25 hCG rapid test cassettes
- 1 lot code cassette
- 25 disposable capillary pipettes
- 1 instruction for use
Performance Characteristics
SmartTester hCG rapid test kit detects hCG levels above 15 mIU/mL. The kit is standardized to the World Health Organization 5th International Standard (NIBSC code: 07/364).
Sensitivity limit of the tests for hCG were assessed using urine samples of non-pregnant individuals spiked with Chorionic Gonadotrophin, (5th IS) to various hCG levels. Samples were tested with three different reagent lots and three different SmartTester instruments. The results of the sensitivity assessment are shown below.
- 0 mIU/mL - 0 % Percent Positive [%]
- 5 mIU/mL - 0 %
- 10 mIU/mL - 28.3 %
- 15 mIU/mL - 96.7 %
- 20 mIU/mL - 100 %
- 25 mIU/mL - 100 %
- 30 mIU/mL - 100 %
- 40 mIU/mL - 100 %
- 50 mIU/mL - 100 %
- 100 mIU/mL - 100 %
Specificity of hCG rapid tests were evaluated with homologous hormones human luteinizing hormone (LH), human follicule stimulating hormone (FSH) and human thyroid stimulating hormone (TSH). The presence of these hormones in the concentrations tested did not affect the test results.
Variants and Related Products
Variants and Related Products
| Order Code | Contents | Size |
| STR-9911 | SmartTester Reader | 1 device |
| RTC-9901-1 | CRP Rapid Test Cartridges | 25 tests |
| RTC-9913-1 | hCG Rapid Test Cartridges | 25 tests |
| RTC-9902-1 | D-Dimer Rapid Test Cartridges | 25 tests |
| RTC-9911-1 | Microalbumin Rapid Test Cartridges | 25 tests |
| RTC-9912-1 | TSH Rapid Test Cartridges | 25 tests |
| RTC-9903-1 | Cardiac Troponin l (cTnI) Rapid Test cartridges | 25 tests |