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B-hCG Test

Quantitative beta‑hCG measurement for pregnancy assessment.

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Only for Professional Use
The Welleo β‑hCG test measures beta human chorionic gonadotropin levels using blood samples. Combined with the Welleo Reader, it provides precise hormonal data to support early pregnancy assessment.
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Technical product

B-hCG Test

Description

Human chorionic gonadotropin (hCG) is a sialylated glycoprotein hormone with a molecular weight of approximately 46,000 daltons. It is secreted by placental trophoblast cells shortly after embryo implantation and serves as a key biomarker for early pregnancy detection. hCG consists of two non-covalently bound subunits: alpha (α) and beta (β). While the α-subunit is shared with other glycoprotein hormones (LH, FSH, TSH), the β-subunit provides hCG its biological and immunological specificity. Quantitative measurement of serum β-hCG enables sensitive and specific detection of pregnancy. hCG levels peak between 60–80 days of gestation, decline gradually by 160–180 days, and remain elevated until delivery. In twin pregnancies, hCG levels are typically more than double those of singleton pregnancies. In contrast, ectopic pregnancies show lower hCG levels compared to normal pregnancies at the same gestational age.

Due to these dynamics, hCG measurement is widely used to: confirm pregnancy, monitor early gestational development, assist in the diagnosis of ectopic pregnancies, predict spontaneous abortion, or detect multiple gestations.

Normal reference values:

Concentration (mIU/mL) | Clinical Interpretation | ≤ 5.0 | Not Pregnant | > 5.0 | Pregnant

Intended use

The Beta Human Chorionic Gonadotropin Assay Kit (Immunochromatographic Assay) is intended for the in vitro quantitative determination of Beta Human Chorionic Gonadotropin (β-hCG) in human serum, plasma, whole blood, and peripheral blood. This is a fluorescence immunoassay designed to assist in the diagnosis of ectopic pregnancy and early pregnancy. For in vitro diagnostic use only. For professional use only.

Principle

The Beta Human Chorionic Gonadotropin Assay Kit utilizes fluorescence immunoassay technology based on a sandwich immunodetection method. When the sample is added to the sample well, the fluorescence-labeled anti-β-hCG detector antibody on the membrane binds to β-hCG antigens in the specimen. As the mixture migrates along the nitrocellulose membrane by capillary action, the formed complexes are captured by immobilized β-hCG antibodies on the test strip. The amount of accumulated complexes is proportional to the concentration of β-hCG in the specimen.

Technical dossier

Laboratory and clinical details

Materials provided
  • Main components (ref. SF370255, SF370256, SF370257):
  • The product is mainly composed of the following items
  • Test cartridge | 15 tests | Detector Buffer | 15 units | Whole blood sampler | 15 units | Lancet | 15 units | Alcohol pad | 15 units | Biohazard bag 15 units | Instructions for use | 1 unit |
  • Note: The components of the different batches of kits are not interchangeable.
Materials needed but not provided
  • - Welleo Lateral Flow Reader (ref. Q1A-DUO-USB)
  • - Centrifuge (for Plasma/Serum only)
  • - Transfer pipette set (100 μL size)
  • - Specimen Collection Containers
Sample collection and preparation
  1. The test can be performed using serum, plasma, whole blood, or peripheral blood specimens.
  2. For Whole Blood Collected by Venipuncture:
  3. - Collect a venipuncture whole blood specimen following standard phlebotomy procedures using a blood collection tube containing a suitable anticoagulant (EDTA is recommended).
  4. - It is recommended to test specimens immediately. Do not leave specimens at room temperature for extended periods. If immediate testing is not possible, specimens may be stored at 2–8°C.
  5. - Whole blood specimens stored at 2–8°C for more than 5 days are not suitable for testing.
  6. For Serum or Plasma:
  7. - Collect a venipuncture whole blood specimen following standard phlebotomy procedures using a blood collection tube. For plasma collection, use a tube containing a suitable anticoagulant (heparin or EDTA is recommended).
  8. - Separate plasma from the blood as soon as possible to avoid hemolysis.
  9. - Testing should be performed immediately after specimen collection. Do not leave specimens at room temperature for extended periods. Specimens may be stored at 2–8°C for up to 7 days. For long-term storage, specimens should be kept below –20°C.
  10. For Peripheral Blood:
  11. - Clean the fingertip with an alcohol pad, remove the lancet cap, and press to puncture. Gently squeeze the finger to obtain an adequate drop of blood.
  12. - Bring the blood collector close to the drop of blood to fill it properly. Ensure the collector is correctly filled.
  13. - Peripheral blood specimens may be stored at 2–8°C for up to 7 days. For long-term storage, specimens should be kept below –20°C.
Storage and stability
  • - The Beta Human Chorionic Gonadotropin Assay Kit (Immunochromatographic Assay) should be stored at a temperature between 2°C and 30°C in its sealed pouch for up to 24 months.
  • - If the kit is stored in a refrigerator, allow the Test Cartridge to reach room temperature for at least 30 minutes before use, keeping it inside the sealed pouch during this time.
  • - Do not remove the device from the pouch until you are ready to perform the test. Once opened, the Test Cartridge must be used within 60 minutes.
Test procedure
  1. Download the app from the Google Play Store or Apple App Store and sign in using your credentials. If registration is required, please contact your distributor. For specific instructions on operating the instrument, follow the guidance provided on the reader.
  2. Step 1: Preparation
  3. Ensure that both the test device and the blood sample are at room temperature before starting. Open the foil pouch, remove the test card, and place it on a flat surface.
  4. Press the “+” button to start a new test, scan the QR code located on the test card, and follow the on-screen instructions. Select the Patient ID, Sample ID, and sample type (if applicable).
  5. Step 2: Sampling
  6. Using a transfer pipette, draw 10 μL of serum, plasma, whole blood, or peripheral blood and add it to the buffer tube.
  7. Step 3: Mixing
  8. Mix the specimen thoroughly with the buffer for 1 minute by gently tapping or inverting the tube.
  9. Step 4: Loading
  10. Take 80 μL (approximately 3 drops) of the mixed sample and dispense it vertically into the sample well of the detection card. Start timing immediately.
  11. Step 5: Testing
  12. Press the “Start Timer” button and wait for the 15-minute reaction period. A countdown timer will be displayed on the screen. The Welleo device must be connected to the mobile app before the timer expires.
  13. Insert the test card into the Welleo device. Once inserted, the animation on the app will change, prompting you to extract the test card at a constant speed. After a few seconds, the test result will be displayed.
  14. If prompted to repeat the reading, follow the instructions provided in the feedback message.
  15. If the test is not processed within 3 minutes after the countdown ends, the result will be considered invalid and a new test must be performed.
Quality control
  • This product used in conjunction with the Welleo Lateral Flow Reader contains internal control for routine quality control requirements. This internal control is carried out every time a patient sample is analyzed. This check indicates whether the test cartridge was inserted and read correctly using the Lateral Flow Reader. An invalid internal control result causes an error message in the analyzer indicating that the test should be repeated.
Performance characteristics
  • - Limit of blank: ≤2.0mIU/mL.
  • - Accuracy: ±15.0%.
  • - Linearity: 5.0mIU/ml， 20000.0mIU/mL, R≥0.99.
  • - Repeatability: CV≤ 15.0 %.
  • - Difference between batches: CV ≤ 15.0 %.
Precautions
- This kit is for in vitro diagnostic use only. Do not ingest.
- Do not mix components from different kit lots.
- Do not use the test kit after its expiration date.
- The Beta Human Chorionic Gonadotropin Welleo Test Kit is designed to work exclusively with the Welleo lateral flow reader. Tests must be performed by trained professional personnel in certified laboratories, separate from the clinical and patient environment, where the sample is collected by qualified medical staff.
- The test cartridge must remain in its original sealed pouch until use. Do not use the cartridge if the pouch is punctured or improperly sealed. Discard after single use.
- The test cartridge and reader must be used away from sources of vibration and magnetic fields. Minor vibrations during normal cartridge use are expected and should be considered normal.
- Use clean and separate pipette tips and buffer vials for each specimen. These components are intended for single use and must be discarded after use.
- Do not smoke, eat, or drink in areas where specimens or kit reagents are handled.
- Use separate, clean pipette tips and detector buffer vials for each specimen. These items must be used for one specimen only and discarded after a single use.
- Blood samples, used test cartridges, pipette tips, and buffer vials may be potentially infectious. Follow appropriate laboratory safety procedures and disposal methods in accordance with microbiological hazard regulations.
- Test results must be interpreted by a physician in conjunction with clinical findings and other laboratory results.
- This test is intended for routine use and not for emergency situations.
Limitations
- This kit is intended solely for the detection of Beta Human Chorionic Gonadotropin in human serum, plasma, whole blood, and peripheral blood.
- The results obtained from the Beta Human Chorionic Gonadotropin Assay Kit (Immunochromatographic Assay) should be interpreted in conjunction with all available clinical and laboratory data. If the test results do not align with the clinical evaluation, additional testing is recommended.
- Specificity: Beta hCG biological reference materials of the same concentration were tested with the addition of 1000 mIU/mL of follicle-stimulating hormone (FSH), 500 mIU/mL of luteinizing hormone (LH), and 1000 μIU/mL of thyroid-stimulating hormone (TSH). Each was tested three times, and the mean and relative deviation of the results were calculated. The relative deviation (Bias%) was within ±15%.
- Interfering substances present in the sample may affect the accuracy of the test results. The following concentrations represent the maximum allowable levels of potential interferents: hemoglobin at 5 g/L, triglycerides at 5 g/L, and bilirubin at 0.2 g/L.
- False positive results may occur due to cross-reactions with similar antibodies in the blood or due to non-specific components with similar epitopes binding to the fluorescent-labeled antibodies.
- False negative results may be caused by various factors, including unknown substances blocking the epitope-binding antibodies, degradation of Beta hCG antigens, or improper sample and reagent handling related to time, temperature, or storage conditions.
- Other factors may interfere with the performance of the Beta Human Chorionic Gonadotropin Assay Kit (Immunochromatographic Assay), potentially leading to inaccurate results. These include technical or procedural errors and the presence of additional substances in the blood specimen.

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