NG Biotech – whole blood pregnancy tests

How do the NG-Test®/ hCG Blood Precision and NG-Test®/ hCG Whole Blood pregnancy tests work?

The NG-Test®hCG Blood Precision and NG-Test®/ hCG Whole Blood are rapid immunoassays for the qualitative detection of human chorionic gonadotropin [1] (hCG) in human whole blood as an aid for the early detection of pregnancy.

The possibility of detecting the hCG in whole blood and serum as early as 7 to 10 days after conception makes it an excellent marker for the early and rapid confirmation of pregnancy. The NG-Test® hCG Blood Precision and NG-Test®/ hCG Whole Blood use highly specific monoclonal antibodies targeting hCG in human whole blood and serum, with a detection threshold of 10mlU/mL.

Detailed specifications are available in the products’ IFUs (see the Resources section for more details).

 

References:

[1] Batzer FR. Fertil Steril. Hormonal evaluation of early pregnancy. 1980 Jul; 34(1):1-13.

…The NG-Test hCG Whole Blood showed good correlation with laboratory results; sensitivity equivalent to venous samples; immediate results (5 min) compared to lab assays (sometimes several hours); Test well accepted by the patient.

Afdjei et al. Poster presentation. Générale de santé, hôpital privé de Parly II, 2015

 

…Diagnosis of pregnancy can be accomplished within minutes by simply applying a drop of whole blood to a standard point-of-care hCG assay kit, obviating the need to wait for acquisition of a patient’s urine.

Fromm et al. Clin Lab Emerg Med. 2012, Sep;43(3): 478-82

 

…The use of whole blood in place of urine for bedside pregnancy testing may reduce result turnaround time without significant changes in accuracy…

Gottlieb et al. West J Emerg Med. 2016; 17(4):449-453 

 

The NG-Test hCG Whole Blood showed a high sensitivity, specificity, PPV and NPV. Its use in triage…is a potential strategy to improve patient flow, with an average saving time of 85 min.

Legoupil et al. Eur J Emerg Med. 2019 Apr;26(2): 105-111

How to use the NG-Test®/hCG Blood Precision:

The test can be performed at any time of the day, as the concentration of hCG in the blood remains more stable than in the urine in case of a positive test. Fresh blood from finger prick/puncture should be used as a test specimen.

How to use the NG-Test®/ hCG Whole Blood:

Fresh capillary blood from finger prick should be used as a test specimen. However, serum is a suitable alternative specimen. The specimen should be collected in a clean glass or plastic container.

Whole Blood – Capillary Collection:

1. Wear protective gloves.
2. Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
3. Clean the patient’s finger with the alcohol swab.
4. Open the pouch and remove the device. Once opened, the device must be used immediately.
5. Open the lancet and prick the lateral side of the patient’s fingertip to obtain a drop of blood (20μL). Using gentle pressure, massage the finger towards the fingertip to encourage a drop of blood to form.
6. Hold the capillary micropipette horizontally (do not press the bulb) and touch with the tip of the micropipette the blood sample. The sampling is realised automatically by capillarity until reaching the black mark.
7. To expel the sample, place the tip of the micropipette in contact with the strip into the “S” well and squeeze the micropipette bulb. Transfer to the sample well must be immediate in order to avoid sample clotting.
8. Add 2 drops of buffer solution (2×40µL) into the “R” well while holding the bottle vertically. Start the timer.
9. Read the results after 5 minutes and interpret them as per IFU. Do not read the test results after 10 minutes.

Serum (from a prepared sample in a laboratory):

1. Collect 10μL of serum using a calibrated micropipette (not included in the kit).
2. Dispense the sample into the “S” well.
3. Add 2 drops of buffer solution (2×40µL) into the “R” well while holding the bottle vertically. Start the timer.
4. Read the results after 5 minutes and interpret them as per IFU. Do not read the test results after 10 minutes.

Instructions for use:

NG Test hCG Blood Precision IFU

NG Test hCG Whole Blood IFU

 

Evaluation summaries

Performance of a quick pregnancy test on whole blood in early pregnancy units:  prospective cohort study.

Caroline Legoupil, Isabelle Enderle, Flore-Anne Le’Baccon, Claude Bendavid, Lucas Peltier, Estelle Bauville, Jean Leveque, Vincent Lavoue and Maela Le Lous. European Journal of Emergency Medicine (September 2017)

 

Researchers have assessed the diagnostic performance of the NG-Test rapid pregnancy test using whole blood in gynaecological emergencies.

This prospective study, led by the department of Gynaecology, Obstetrics and Reproductive Medicine, Biochemistry, University of Rennes, Faculty Medicine, University of Rennes and INSERM U1242, Rennes, France, included 200 women consulted in early pregnancy units for vaginal bleeding and/or pelvic pain with unknown pregnancy status after medical consultation including a pelvic ultrasound scan. A new POC test (the NG-Test hCG Whole Blood) and the usual laboratory serum test (considered the gold standard) were performed in patients. The results were interpreted in a blinded manner.

The pregnancy rate was 17%. For the laboratory test, with a 5 Ul/l hCG positivity threshold, the sensitivity, specificity, PPV, NPV of the NG-Test hCG Whole Blood were 89.7, 100, 100, 97.9, respectively. Considering a 10Ul/l hCG positivity threshold, test sensitivity, specificity, PPV, NPV, were 96.3, 100, 100, 99.3, respectively. False-negative cases were either extremely brief pregnancies or residual hCG after miscarry test.

In conclusion the NG-Test hCG Whole Blood was easy to use and showed a high sensitivity, specificity, PPV and NPV. Its use as triage in the case of a negative pelvic ultrasound exam is a potential strategy to improve patient flow, with an average time saving of 85 minutes.