History

Ancient
Egyptians
Hippocrates
Selmar
Aschheim and
Bernhard
Zondek (1928)-
female mouse
test /rabbit test
Present
 Urine Test

 Serum Test
 Qualitative
 Quantitative
General Aspects
 The Need for Performing
the Test

 Principle Underlying
– Types of hCG s
• hCG-1
• Pituitary hCG
• hCG-3
– Heterogenecity
 hCG in
urine/Home
pregnancy tests
hCG in urine/Home pregnancy
tests
Advantage
Privacy and ease of self administration
Convenience
Quick
Disadvantages
hCG can be detected when only above
20mIU/mL
Only qualitative
Not as accurate as serum tests
 Home Test Kit Components:

 Test strip
 Absorbent pad
 Desiccant pouch
 Plastic housing
 Cardboard Box
Basic Components of test
strip
• 1st Band:"anti-a" hCG
antibody &
Immunoglobin G
(or IgG)

• 2nd Band:"anti-b" hCG

antibody

• 3rd Band: antibody for IgG

At 1 Band
st
At 2 nd
Band
Home Pregnancy
Test Preparation
• Label instructions
• Following
instructions
• FDA regulation
• Records
• Doubts
• For better results
 Home Pregnancy
Testers
Urine Collection Cups
Test Strips and Dipsticks
Test Cassettes and Midstreams
One-Step Insta Testers
Others
Urine Collection Cup
Test Strips and Dipsticks
RESULTS
Test Cassettes and
Midstreams
Result Interpretation
One-Step Insta
Testers
 TYPE ACCURA TIME SPECIFI SHELF BRANDS
CY Reqd.(m CITY For LIFE
ins.) hCG (months
)

Test 20-25 5 >99% 22-24 Advance,

strips & mIU/mL Clearblue ,
Dipstrips Answer,
E PT

Cassettes 20 2-5 99% 12-18 Fact Plus,

mIU/mL Precise

Insta 20mIU/mL 2-5 99% 24 One Step

Be Sure
Testers
Rapid Self-
Test (U.K.)
 BRANDS AVAILABLE
•International brands based on sensitivity to hCG in mIU/mL
20 (+) 25 (+) 50 (+) 100 (+) 150
Aim Stick Clearblue Clearblue Answer Fact(+)
Plus
Easy(U.K.) Easy(U.S.)
PBD hCG Conceive
Aim Step Clear Plan Easy Equate
First Response™ CVS Pharmacy (WalMart)
Cassette (Cartridge)
hCG Aim Confirm First Response
Early Bird One Dipstick (U.S.)
Mid- stream 1-Step d-Best Step Early
OTC hCG CVS Pharmacy Pregnancy test Precise
Day Seven e.p.t.
Pregnancy QTest
InstaTest hCG 1stResponse (U.K.) Walgreen’s
Generic
One Step Be Hannaford
Sure Predictor (U.K.)
Rapid Self-Test
(U.K.) Rite-Aid Generic
Selfcare
Target
 BRANDS AVAILABLE
•International brands based on no. of days after missed period

Product Day of Numb Specimen Process

Missed er requireme ing
period of nts time
Answer Quick Day 2 ste
7 steps Any 3 minutes
& Simple ps
Fact Plus Day 1 3 steps First a.m. 5 minutes
Clearblue Easy Day 1 1 step First a.m. 3 minutes
Conceive Day 1 1 step Any 1-3 minutes
First Response Day 1 1 step Any 3 minutes
Confirm Day 1 1 step Any 5 minutes
E.P.T. Day 1 1 step Any 2 minutes
Precise Day 1 1 step Any 1 minute
Q-Test Day 1 2 steps Any 1 minute
 BRANDS AVAILABLE
•Indian brands
Product Company Cost / Strips /
pack pack
Velocit Dr. Reddy’s Rs.41.40 One

Preg Colour Card INFAR Rs.47.50 One

Preg Test Cipla Rs.54.10 One

Analytica Ranbaxy Rs.40.10 One

En-Sure (Generic) Rapha Diagnostics Rs.27.45 One

 Errors
False negative Manner of sample
results collection
Calculations of Time of day
Menstruation Medication
ovulation
implantation
False positive
results
hCG injection
Phantom hCG
 hCG in Blood
serum-
Qualitative &
Quantitative
tests
Need
Sensitivity:5mIU/mL to 2,000,000mIU/mL
Procedure
 Doubling Rule
Normal Values:
 Not pregnant: less than 5mIU/mL
 Pregnant: atleast 25mIU/mL,rises entire
trimester as in table given below & then
falls.

hCG Level in Time required

mIU/mL
Below 1,200 to double
48-72 hours
1,200 to 6,000 72-96 hours
Above 6,000 More than 96 hours
Normal values
Abnormal results mean:
• Higher than normal
– More than one fetus
– Ovarian or testicular cancer
– Choriocarcinoma of uterus
• Lower than normal
– Fetal death
– Miscarriage
– Ectopic pregnancy
 Special
Considerations:
 Drugs that decrease hCG
measurement
 Diuretics
 Promethazine

 Drugs that increase hCG

measurement
 Anticonvulsants
 Antiparkinsonian drugs
 Phenothiazine
 References:
• Pharmacy Times, October 2004 • S.Pathak and U.Palan
• Richard.A.Goldsby and Thomas.J.Kindt Immunology-Essential and Fundamental
Immunology Second edition
Fifth edition Page no. 317
Page no. 148-151
• Ashin.K.Chakravarty • http://history.nih.gov/exhibits/thinblueline/
Immunology and Immunotechnology • http://www.fda.gov/edrh/oivd/homeuse-
First edition pregnancy.html
Page no. 234-235 • http:// www.pregnancy-Tests.big.com
• Ivan Roitt • http://drmalpani.com/book/chapter48.html
Essential Immunology
• http://www.4woman.gov/faq/pregtest.htm
Ninth edition
Page no. 113- 114, 403, 375
• http://www.webindia123.com/health/woman
•
/pr egnancy/pretest.htm
Daniel.P.Stitis and John.B.Imboden
Medical Immunology • http://en.wikipedia.org/wiki/pregnancy_test
Tenth edition • http://www.early-pregnancy-tests.com/
Page no. 221-224 • http://www.accuratepregnancytests.com/pr
• Mark Peakman and Diego Vergani egnancy_ovulation_tests.php/042978
Basic and Chemical Immunology • http://www.nlm.nih.gov/medlineplus/ency/a
First edition rticle/003432.htm
Page no. 186
• D.M.Daniel
Immunology-An Outline For Students Of Medicine
and Biology
Fifth edition
Page no. 236-238