Experiment- 7
Study of Pregnancy Diagnosis Test
Aim: To study pregnancy diagnosis test.
Reference: Despande A. Shilpa, V. Yawashare S. Niraj, Amale N. Prashant, Shirode S. Devendar
by Nirali Prakashan, first Edition, 2018, pageN0-
73-75.
Requirements: Any one marketed single use pregnancy detection kit (which contains 1 test device
and 1 disposable dropper, vial), urine sample.
Principle:
Pregnancy test helps to determine whether a woman is pregnant or not. The fertilized egg secretes
the hormone called Human Chorionic Gonadotropin (HCG) which is found in urine during early
pregnancy. When urine sample of pregnant women is reacted with specific HCG antibodies
precipitation, hemagglutination or complement fixation like reaction occur which is used as
diagnostic test for pregnancy. These tests can be performed using immunological, biological and
radiological techniques L
I. Immunological tests: These are commonly used and performed with the help of readily
available marketed kits based on the reaction between urine HCG and specific HCG antibodies.
Working Principle of Immunological Test:
This test gives qualitative detection of HCG in the urine. It is based on the combination of urine
HCG with monoclonal antibody-dye conjugate and polyclonal HCG antibodies present on the strip
of a diagnostic kit. A urine sample is applied to the test zone of the strip. If HCG is present,
antibody-HCG-antibody dye complex will be formed and a pink-purple coloured band develops.
A control zone is provided to check the potency of the test reagents, flow and volume of urine
added.
II. Biological tests involve injection of urine sample into various animals. They are accurate but
time consuming and costly.
III. Radiological tests are performed by Radioimmunoassay (RIA) and Enzyme linked immune
sorbent assay (ELISA) techniques using radio-labelled HCG and its specific antibodies.
IV. Ultrasonography is a reliable method for detecting pregnancy which uses pulses of ultrasonic
waves at high frequency on various parts of uterus. The echoes (reflected waves) are displayed on
the ultra sound screen and thereby confirms pregnancy. The pregnancy can be evident as early as
5th week.
Figure 5:
Procedures:
1. Collect the first urine sample in the morning in clean container (First few ml of urine shall be
discarded and then collected).
2. Add 2-3 drops of urine on strip and observe the colour change of the bands, if any, on the test
and control zones.
3. Read the results as positive (i.e. development of pink or purple colour on both control and test
zone) or negative (i.e. development of pink or purple colour only on control zone).
Note: False positive (test is positive but the female is not pregnant) or false negative (test is
negative but female is pregnant) result is the major limitation of this test.
Sl. No Test results Major reason
1. False positive · Excess protein
· Blood in urine
· HCG production due to cancerous condition
· Diuretics
2. False Negative · Too early testing
· Ectopic pregnancy
· Benzodiazepines
Result: The study of pregnancy diagnosis test was successfully Done.