HistoryAncient

EgyptiansHippocratesSelmar Aschheim

and Bernhard Zondek (1928)-female mouse test /rabbit test

Frog Test (1950s)

Present

Urine Test

Serum Test Qualitative Quantitative

General AspectsThe Need for Performing

the Test

Principle Underlying– Types of hCG s

• hCG-1

• Pituitary hCG

• hCG-3

– Heterogenecity

hCG in urine/Home

pregnancy tests

Advantage Privacy and ease of self administrationConvenienceQuick

DisadvantageshCG can be detected when only above

20mIU/mLOnly qualitativeNot as accurate as serum tests

hCG in urine/Home pregnancy tests

Home Test Kit Components:

Test strip Absorbent pad Desiccant pouchPlastic housingCardboard 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 1st Band

At 2nd Band

Home Pregnancy Test Preparation

• Label instructions• Following

instructions• FDA regulation• Records• Doubts• For better results

Home Pregnancy Testers

Urine Collection CupsTest Strips and DipsticksTest Cassettes and MidstreamsOne-Step Insta TestersOthers

Urine Collection Cup

Test Strips and Dipsticks

RESULTS

Test Cassettes and Midstreams

Result Interpretation

One-Step Insta Testers

TYPE ACCURACY

TIME Reqd.

(mins.)

SPECIFICITY For

hCG

SHELF LIFE

(months)

BRANDS

Test strips & Dipstrips

20-25 mIU/mL

5 >99% 22-24 Advance, Clearblue , Answer,

E PT

Cassettes

20 mIU/mL 2-5 99% 12-18 Fact Plus, Precise

Insta Testers

20mIU/mL 2-5 99% 24 One Step Be Sure Rapid Self-Test (U.K.)

BRANDS AVAILABLE•International brands based on sensitivity to hCG in mIU/mL

20 (+) 25 (+) 50 (+) 100 (+) 150 (+)

Aim Stick

PBD hCGAim Step

Cassette hCG Aim

Mid- stream OTC hCG

Clearblue Easy(U.K.) 

First Response™

Confirm

1-Step d-Best CVS PharmacyDay Seven PregnancyInstaTest hCG

One Step Be Sure Rapid Self-Test (U.K.)

Clearblue Easy(U.S.)

Clear Plan EasyCVS Pharmacy (Cartridge)

Early Bird One Step Early Pregnancy test e.p.t.

1stResponse (U.K.)

Hannaford Predictor (U.K.)

Rite-Aid Generic SelfcareTarget

Answer

ConceiveEquate (WalMart)

First Response Dipstick (U.S.)

Precise

QTestWalgreen’s Generic

Fact Plus

BRANDS AVAILABLE•International brands based on no. of days after missed period

Product Day ofMissedperiod

Number

of steps

Specimenrequireme

nts

Processing

time

Answer Quick & Simple

Day 2 7 steps Any 3 minutes

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 / pack

Strips / 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 results

Calculations of Menstruation ovulation implantation

False positive results

hCG injection Phantom hCG

Manner of sample collection

Time of dayMedication

hCG in Blood serum-

Qualitative & Quantitative

testsNeedSensitivity:5mIU/mL to 2,000,000mIU/mL

Procedure

Doubling Rule Normal Values:

Not pregnant: less than 5mIU/mLPregnant: atleast 25mIU/mL,rises entire

trimester as in table given below & then falls.

hCG Level in mIU/mL

Time required to double

Below 1,200 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• Richard.A.Goldsby and Thomas.J.Kindt

ImmunologyFifth editionPage no. 148-151

• Ashin.K.ChakravartyImmunology and ImmunotechnologyFirst editionPage no. 234-235

• Ivan RoittEssential ImmunologyNinth editionPage no. 113- 114, 403, 375

• Daniel.P.Stitis and John.B.ImbodenMedical ImmunologyTenth editionPage no. 221-224

• Mark Peakman and Diego VerganiBasic and Chemical ImmunologyFirst editionPage no. 186

• D.M.DanielImmunology-An Outline For Students Of Medicine and BiologyFifth editionPage no. 236-238

• S.Pathak and U.PalanImmunology-Essential and FundamentalSecond editionPage no. 317

• http://history.nih.gov/exhibits/thinblueline/• http://www.fda.gov/edrh/oivd/homeuse-

pregnancy.html• http:// www.pregnancy-Tests.big.com• http://drmalpani.com/book/chapter48.html• http://www.4woman.gov/faq/pregtest.htm• http://www.webindia123.com/health/

woman/pr egnancy/pretest.htm• http://en.wikipedia.org/wiki/pregnancy_test• http://www.early-pregnancy-tests.com/• http://www.accuratepregnancytests.com/

pregnancy_ovulation_tests.php/042978• http://www.nlm.nih.gov/medlineplus/ency/

article/003432.htm