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All You Need To Know From Puberty To Menopause

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From Puberty To Menopause, Comforting Care For Every Cause

Puberty, Reproductive and Infertility Stage

LH, FSH

FSH (Follicle Stimulating Hormone)

• Stimulates follicular growth & seminiferous tubules

LH (Luteinizing Hormone)
• Stimulates ovulation, production of estrogen & progesterone
• Controls the production of testosterone by leydig cells
• Diagnosis of gonadal, pituitary & hypothalamic disorders

 


Bone Mineral Density (BMD)


• Bone Mineral Density (BMD) estimates the true mass of bone
• Helps predict the risk of osteoporosis & future fracture so that a treatment program can be optimized
• BMD test results are estimated on the basis of:
T-Score:
• The patient’s bone mineral density as compared to the peak bone mass in normal young adult        
• A score of 0 means BMD = norm of a healthy young adult
•The diagnosis of osteoporosis or low bone mass is based on T-score

Z-Score:
• The patient’s bone mineral density as compared to the peak bone mass in age-sex matched adult
• Z-Score is useful for determining whether an underlying disease or condition is causing bone loss

 


FT (FT3, FT4 & TSH)


• Free T3, Free T4 & TSH (Thyroid hormones) have profound effects on reproduction and pregnancy
• Thyroid dysfunction is implicated in a broad spectrum of disorders, ranging from:
• Abnormal sexual development
• Menstrual irregularities
• Infertility
• Assessing true metabolic status
• Diagnosing Hyper & Hypothyroidism
• Autoimmune Thyroiditis (ATAB)

 


Histopathology (Expertise for detailed diagnosis)

Core specialities include:
• Gross examination procedure by dedicated histopathologist
• Application of stringent diagnostic criteria/protocols for reporting (CAP)
• Application of special stains and IHC markers whenever necessary
• Interaction with concerned doctors before reporting critical reports
• Use of Cytospin 4 for Fluid cytology

 


Anti Mullerian Hormone (AMH)

Auto Magic Hormone( AMH)
• Evaluating the fertility potential
• Better response to ovarian stimulation for IVF
• Assessing Polycystic Ovarian Syndrome
• Measuring ovarian ageing
• Predicting onset of menopause
• Early and Delayed Puberty
• Guide for Contraception
• Endometriosis diagnosis and prognosis
• Testicular (Gonadal) Function

5.5% cancers missed by PAP+HPV Together
Cervical cancer screening with greater assurance

 


HPV DNA Detection & Genotype

Rapid and sensitive test for detection of HPV DNA
• Detect 40 HPV types involved in causing precancerous lesions and cervical cancer
• Detects all 14 High Risk (HR) types and other Low Risk (LR) types
• HR types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 or 68
• HPV 16/18 is the most carcinogenic HPV genotype and accounts for 75 – 85% of all cervical cancers
• Approximately 10 other HR HPV genotypes cause the remaining 15 – 25% of cervical cancers

 


PROGESTERONE


• Progesterone levels vary throughout the menstrual cycle
• Decreases in follicular phase
• Increases in luteal phase
• Progesterone is vital in continuation of pregnancy
• Serial measurements of Progesterone are used to determine whether ovulation has occurred, or to monitor the success of induced ovulation
• Increases in:
Ovarian tumors | Adrenal Tumors | Molar pregnancy
• Decrease in:
Amenorrhea | Fetal death | Gonadal agenesis

 


BRCA 1&2


• Once in a lifetime test for detection of hereditary Breast and Ovarian cancer risk
• BRCA1 mutations confer more than 80% lifetime risk for breast cancer
• In-depth analysis by NGS and confirmation by Sanger sequencing (Gold Standard Technique)
• If patient is positive for mutations, relatives and children can be screened for high risk
• We provide pre-test and post-test counselling

 


DHT (Dihydrotestosterone)


• Endogenous potent male sex hormone
• More potent than Testosterone
• During embryogenesis, DHT has an essential role in the formation of male external genitalia
• In the adult, DHT acts as the primary androgen in prostate and hair Follicles
Helps identify:
• In males:
• Infertility • Decreased libido • Erectile dysfunction • Hypogonadism

 


Urine Culture


• Urine culture is the commonest sample received in microbiology laboratory
• Urinary isolate is identified and susceptibility is done using Vitek 2 Compact
• The susceptibility to various groups of antibiotics is deduced using MIC values
• The interpretation is based on the latest CLSI guidelines
• We use special boric acid containers which is a urinary preservative and it maintains the colony count of bacteria and avoids over growth

 

Pre and Post Menopause Stage

 


25-Hydroxy Vitamin D


80% of the Indian population have Vitamin D levels less than normal*
• Vit D2 is obtained from dietary sources
• Vit D3 is obtained from Early Morning Sunlight
• Both get metabolized in the liver to form 25-OH Vit D
• Helps in timely detection & management of Osteoporosis
• Helps in maintaining good bone mineral density which is important to prevent future fracture

 


Prolactin


• Evaluation of menstrual irregularities
• Predicting ovulation
• Evaluating infertility
• Evaluating patients with suspected hypogonadism
• Evaluating PCOS
• Evaluating Galactorrhea

 


HE4 + CA 125 (ROMA Index)

• HE4 is used as an aid in monitoring recurrence or progressive disease in patients with invasive epithelia ovarian cancer.
• CA125 is used to detect ovarian cancer and monitor therapeutic response
• CA125 + HE4 combination (ROMA)
• Increases sensitivity(75%) and specificity(94.9%) for ovarian cancer detection
• Accurately stratified 89% of all epithelial ovarian tumor and low malignant potential tumors as high risk and 75% of all benign disease as low risk

 


ESTRADIOL (E2)


• Determine the timing of ovulation
• In males, Estradiol helps detect hormonal excess and its cause
• Is involved in development & maintenance of female phenotype
Helps identify:
• In females: Precocious puberty | Amenorrhea | Infertilty | Detection of ovarian failure | Monitoring of follicle development in ovary by serial measurements
• In males: Delayed Puberty | Infertility | Gynaecomastia | Signs of feminisation in pubertal boys

 


Papsure

18.6% cancers missed by HPV-Alone

12.2% cancers missed by PAP-Alone

Performed on fully automated machine

• Screening Test to detect cervical cancer and precancerous conditions
• Cell enrichment process separates & removes blood, mucus & other cells reducing the risk of missed diagnosis
• Faster turnaround time
• Unsatisfactory rates have decreased from 0.98% in conventional smears to 0.24% in Sure Path Laboratories. (Multicentre large studies by various Laboratories)
• Same sample can be used for HPV test

 


Polycystic Ovarian Syndrome (PCOS)


• Apart from the known co relation of PCOS and increased risk of type 2 Diabetes, there is increasing evidence of link between PCOS and Thyroid disorders as well.
• Despite the high prevalence of PCOS, the diagnosis and differential diagnosis remains confusing.
• This is partly due to the lack of a specific single diagnostic test for the disorder
• Tests to detect PCOS:
FBS, PPBS | DHT | HOMA Index | Lipid Profile | Free testosterone | FT3, FT4, TSH | FSH, LH, | Prolactin | SHBG | 17-OHP | Cortisol | Androstenedione | AMH | DHEAS | USG Pelvis

 


Testosterone


• Diagnose several conditions in males and females
• In females the test is prescribed
• Infertility
• Amenorrhea
• Oligomenorrhea
• Hirsutism
• PCOS
• In males the test is prescribed
• In case of infertility
• Decreased sexual drive
• Lack of secondary sexual characters in males
• Only 2-3% of circulating testosterone is free

 


Mammography

• About 1.3 lakh fresh cases of breast cancer are diagnosed in India every year
• The most efficient screening method to detect early breast cancer
• A mammogram is an X Ray that produces an image of the inner breast tissue on film
Complimented by sono-mammography
• The technique is used to visualize normal and abnormal structures like cysts, calcifications, and tumors within the breasts
• Mammography can be used to discover a small cancer in a curable stage

 

Pregnancy Stage

 


Prenatal BoBs


• Confirmatory diagnosis for screen positive Trisomy by when 1st or 2nd Trimester screening has indicated a high risk of anomaly
• Detects changes of chromosome 13,18, 21 X & Y and also enables detection of 9 microdeletion syndromes
• There are no unknown clinical significant results as there is a clear genotype-phenotype correlation for the micro deletion syndromes detected by Prenatal BoBs
• High sensitivity and specificity (upto 99% detection rate with false positive < 1% & false negative rate of< 2%)
• Better TAT and additional information regarding the micro deletion

Aneuploidies
Trisomy 13: Patau Syndrome 13
Trisomy 18: Edwards Syndrome 18
Trisomy 21: Down Syndrome 21
Sex Chromosome Abnormalities X & Y

Microdeletion Syndrome
DiGeorge Syndrome 22q11.2
DiGeorge 2 Syndrome :10p14
Williams-Beuren Syndrome :7q11.2
Prader-Willi Syndrome :15q11-q12
Angelman Syndrome :15q11-q12
Smith-Magenis Syndrome :17p11.2
Wolf-Hirschhorn Syndrome: 4p16.3
Cri du Chat Syndrome :5p15.3-p15.2
Langer-Giedion Syndrome: 8q23-q24
Miller-Dieker Syndrome :17p13.3

 


Sex Hormone Binding Globulin (SHBG)


• Increased SHBG levels are seen in hormone replacement therapy (steroids & estrogen), pregnancy, hyperthyroidism
• Decreased SHBG levels are seen in obesity, PCOS, hypothyroidism
Helps identify:
• In males:
• Infertility • Decreased libido • Erectile dysfunction • Hypogonadism
• In females:
• Menstrual irregularities • Hirsutism • Infertility • PCOS

 


Integrated Test


• Dual Test + Quadruple Marker Test
• All maternal markers analyzed – âhCG, PAPP-A, AFP, Inhibin-A, uE3 on the AutoDELFIA® platform from PerkinElmer, are CE-marked
• Detection rate upto 95%
• Graphical interpretation of reports with PerkinElmer’s clinically validated LifeCycle™ screening management software

 


Antinuclear Antibodies (ANA)

• The Gold Standard technique to detect presence of antibodies
• Combination of HEp -2010 cells and primate liver cells provides
• Pattern differentiation which corresponds to particular disease type (centromere, nuclear dots)
• Provides additional information for ANA – ve cytoplasmic antibodies (liver disease-endomysium, ANCA)
• Patterns offer clue to which particular autoantibody may be present corresponding to particular disease type: Homogenous | SLE Speckled | Sjogrens Syndrome Centromere | Scleroderma Nucleolar | Scleroderma
• Confirmed by ANA Blot tests or monospecific ELISA

 


Dual Marker Test


• Risk interpretation based on MoMs of Indian population developed by screening more than 4 lakh pregnancies over the years years
• All maternal markers analyzed – âhCG, PAPP-A on the AutoDELFIA®
platform from PerkinElmer, are CE-marked
• Gestational age for performing the test
• Detection rate upto 91%
• Graphical interpretation of reports with PerkinElmer’s clinically validated LifeCycle™ screening management software
• Uses FMF (UK) approved PerkinElmer Dried Blood Spot (DBS) technology for first trimester aneuploidy screening

 


Anti Phospholipid Antibodies (APLA)


• Antiphospholipid antibodies is used to determine the cause of inappropriate blood clot formation (unexplained thrombotic episode, excessive clotting) and recurrent miscarriage
• APLA are found in Antiphospholipid syndrome & SLE
• In positive cases tests needs to be repeated 8 to 10 weeks later to determine whether their presence is persistent or temporary

 


Hb Electrophoresis


• Performed on automated HPLC technology for accurate reports
• Helps detection & quantification of Hemoglobin fractions
• Comprehensive test to screen common Hb variants Hb S, C, E and D in addition to beta Thalassemia
• Estimates Hb A2 and F levels, an important tool in the carrier testing

• Anemia
• Causes of Anemia :
• Physiological Anemia
• Nutritional Anemia
• Hemolysis and Hemolytic Anemia
• Hemoglobinopathies

 


TB PCR


• Performed using Real Time PCR technology
• Tests can be performed on
• Pulmonary AFB smear negative
• Paucibacillary extra pulmonary TB (10-15% of all TB cases)
• Targets IS6110 gene more prevalent in Indian population hence specificity is higher even in case of 1 bacillus

 


ßhcg


• Prenatal Screening
• Diagnosis of pregnancy
• Detection of ectopic pregnancy
• Gestational Trophoblastic Disease
• Germ Cell Tumors
ßhcg becomes detectable 3 days post implant

• Detection of ectopic pregnancy
• Slow increase in HCG (<66% in 48 hours during first 40 days of pregnancy) indicates Ectopic pregnancy in 75% of cases.

 


KaryoLite BoBs (POC)


• Performed by BACs-on-Beads based molecular karyotyping, covering both p and q arms of all
chromosomes 1 – 22 X and Y

• KaryoLite BoBs offers multiple benefits
• Rapid aneuploidy detection
• No requirement of cell culture
• Chances of Failure is less than conventional Karyotyping
• Faster TAT than Karyotyping

• Concordant results with
• Microarrays and conventional Karyotyping for aneuploidies
• More information than FISH
• Small amount of DNA sample required (50 ng to 240 ng)

References :
PKI Brochure: BoBs_Karyolite 1244-9957-01, November 2011 PKI Technical Note: BACs-on Beads-Molecular Karyotyping 1244-9915-01, June 2009 Rapid aneusomy detection in POC using KaryoLite(TM) BACs-on Beads assay

 

Pregnancy and infertility stage

 


Bad Obstetric History (BOH)


• Abortion affects 1-3% of fertile couples
• Bad Obstetric History (BOH) implies two or more consecutive abortions,
early neonatal deaths, stillbirths, intrauterine fetal death
Causes of Abortion :
• Genetic – Karyotyping for couple (Chromosome analysis evaluates the number and structure of chromosomes in order to detect abnormalities)
• Infections – TORCH
• Endocrine – Thyroid stimulating TORCH Hormone (TSH)
• Immunological – Anti-Phospholipid | Antibodies IgG & IgM | Anti-Cardiolipin | Antibodies IgG & IgM | Lupus Anti-coagulant (LA)

 

Triple Marker Test

Detection rate~65%
• Risk assessment test in 2nd Trimester to detect Trisomy 18, Trisomy 21 & Neural tube defect
• All maternal markers analyzed – âhCG, AFP, uE3 on the AutoDELFIA® platform from PerkinElmer, are CE-marked
• Risk interpretation based on MoMs of Indian population developed by screening more than 4 lakhs pregnancies over the years
• Graphical interpretation of reports with PerkinElmer’s clinically validated LifeCycle™ screening management software

 


Anti Cardiolipin Antibodies (ACLA)


• Plays an important role in the blood clotting process
• When antibodies are formed against cardiolipins, they increase the risk of developing recurrent blood clots in arteries and veins
• ACLA are found in Antiphospholipid syndrome & SLE
• Antiphospholipid syndrome is an autoimmune syndrome which presents with venous or arterial thrombosis, thrombocytopenia, recurrent abortions & eclampsia
• Used for identification of recurrent abortions

 

Quadruple Marker

DOWN SYNDROME AND BEYOND
• Inhibin A with Triple Marker increases detection rate upto 75%
• All maternal markers analyzed – âhCG, AFP, Inhibin-A, uE3 on the AutoDELFIA® platform from PerkinElmer, are CE-marked
• Risk interpretation based on MoMs of Indian population developed by screening more than 4 lakhs pregnancies over the years
• Graphical interpretation of reports with PerkinElmer’s clinically validated LifeCycle™ screening management software

 


Lupus Anticoagulant (LA)


• Test based on guideline by International Society of Thrombosis And Hemostasis (ISTH)
• Helps determine the cause of an unexplained – Thrombosis | Recurrent Miscarriages | Prolonged PTT
• Test based on two different principles: dRVVT | Sensitive aPTT
• LA considered positive if at least one of the two tests gives positive Results
• In positive cases, test needs to be repeated 12 weeks later to determine whether lupus anticoagulant is transient or persistent

 


Sonography

N T Scan (11-13.6 weeks)
• Assesses risk of having Down’s Syndrome and other chromosomal abnormalities
• The minimum fetal crown–rump length (CRL) should be 45 mm and the maximum 84 mm
• At Suburban Diagnostics Radiologist are Fetal Medicine Foundation (FMF) UK certified

Anomaly Scan (18-23 weeks)
•Screen structural and developmental abnormalities
   • Neural Tube Defect (NTD)
   • Fetal aneuploidy

 

TORCH

• Infections by TORCH in women are usually asymptomatic and chronic which leads to – Neonatal Death | Intrauterine Growth Retardation | Recurrent Abortion | Intrauterine Death | Preterm Labor | Congenital Malformation
• Based on the findings of the study (TORCH profile in patients with bad obstetric history in 2012) it was concluded
• Previous history of pregnancy loss and TORCH infections during current pregnancy must be considered while managing BOH cases to reduce the adverse fetal outcome
• Tests in TORCH panel: Toxoplasma | Rubella | CMV | HSV

 


Antenatal Panels


• An essential assessment for every pregnant woman to ensure healthy pregnancy
• Assist you in predicting the chances of Diabetic baby & ABO-Rh incompatibility
•Antenatal Panels available:
• Antenatal Panel 1: CBC, FBS, Blood Group, HIV, HBsAg, VDRL, Urine Routine
• Antenatal Panel 2: Ante Natal Panel 1 + TSH
• Antenatal Panel 3: Ante Natal Panel 2 + BUN + Hb Electrophoresis

 


Sonography


• State-of-the-Art machines from
• GE Voluson P8 • Philips HD 15 & HD 11 • Toshiba Nemio-XG
• Clinical findings are discussed with prescribing doctor through telecon
• Sonography is available across all Suburban radiology centres between 9am to 1pm (Mon-Sat) & at select centres in the evenings

Pelvic Sonography
• Evaluation of pelvic organs such as Uterus and Ovaries
• Evaluate Adnexa

Pelvic Doppler
• Determine vascularity in conditions such as Ovarian torsion

Follicular study
• Monitor follicular growth and Ovulation

 


Doppler

Obstetric Sonography
• Estimation of: Gestational age | Fetal growth | Fetal well being

• Obstetric Doppler
• Study of fetal hemodynamics
• Assess utero-placental and feto-placental sufficiency

 

CENTRAL PROCESSING LAB

Aston, 2 nd Floor, Sundervan Complex, Opp. Union Bank, Above Mercedes Showroom, Andheri West, Mumbai – 400053

Book your appointment to test your puberty or menopause.

Maternal Screening For Healthy Baby

Maternal Screening Blog Image

A HEALTHY BABY IS EVERY MOTHER’S MOST CHERISHED TREASURE

Know More About Maternal Screening…From the Expert…

1. Why is Dual Marker not done when one fetus is aborted in case of twin pregnancies?

• If one fetus is aborted, we need to look for the fetal pole. If fetal pole is present in the demised twin, dual test is not possible as there will be production of substances (PAPP-A & Free βhCG) from the demised twin and resulting interpretation will be erroneous. Fetal pole needs 8-9 weeks to close in cases where one fetus in aborted/ fetal reduction If there is no fetal pole we can take the pregnancy as singleton and dual test can be processed.

 

2. Why do we report single risk in monochorionic twins although the CRL (Crown-rump Length) & NT (Nuchal Translucency) values are different?

• Monochorionic twins originate from the same embryo, so they are assumed to be genetically identical although there is difference in biometry.

 

3. What is the benefit of NT value measured using FMF (Fetal Medicine Foundation) guideline?

• FMF guidelines provide a standardized methodology for NT measurement. This is paramount in maintaining the sensitivity of the combined screening as it contributes significantly (about 70% to the 91%) detection rate in dual test.

 

4. What is Corrected MoMs?

• Corrected MoMs are MoMs with weight corrections
» Weight correction should be applied to all analytes in Down’s syndrome screening
» Evidence shows that weight correction improves detection rate
» Multiple median values can be significantly affected by weight correction

 

5. What is the importance of the sample collected on DBS card over serum?

• Free βhCG is more stable and intact on DBS card. Also dissociation from free βhCG occurs slow onDBS card.

 

6. Why is maternal screening not done between 14 th & 15 th week of gestation?

• One of the most discriminating marker for NTD is AFP which is best accessed from 15 th week for quadruple test. Hence, the window 14 to 15 week is not ideal for dual or quadruple test.

 

7. Why we do not report patau syndrome (T13) in 2 trimester screening?

• Sensitivity of patau syndrome is very low in 2 trimester as pregnancies diagnosed with T13 end in miscarriages between 12 to 15 week of gestation (https://www.ncbi.nlm.nih.gov/pubmed/18361449 it is published in AJMG for the incidence to term for T18 and T13)

 

8. What is the difference between Lifecycle software, ssdw, Astria and Prisca?

• LifeCycle TM risk calculation engine is a comprehensive informatics package for maternal health monitoring and risk assessment. An accessible patient data management system is coupled with a flexible risk calculation engine, which can be configured to meet local variations. Because the system has been fully validated and all calculation methods, algorithms and values are supported by current published literature, LifeCycle gives full confidence in maternal risk assessment program.

 

9. Insights of Pre-eclampsia (PIGF- PLACENTAL GROWTH FACTOR)

• Pre-eclampsia is a sudden increase in blood pressure and protein in the urine after the 20th week of pregnancy. Pre-eclampsia can lead to eclampsia, or convulsions, posing serious health implications for mother and baby. Symptoms of pre-eclampsia may include:

» High blood pressure (≥140/90 mmHg)

» Swelling in the face and hands (and feet, although swollen feet are common during pregnancy)

» Weight gain of more than 2 kgs in a week

» Other problems such as headache, blurred vision, abdominal pain and nausea

 

10. What is MAP & uAD and what is the relevance in PlGF test?

• Mean Arterial Pressure (MAP) – Accurate measurement of blood pressure in pregnant women is particularly important when attempting to identify early signs of pre-eclampsia. As a means of prediction it has been suggested that the MAP, whether measured in the first or second trimester, is better than systolic blood pressure, diastolic blood pressure, or an increase of blood pressure. In clinical practice MAP measurement in the first trimester may not make a clinical impact in isolation but could be suitable for use with other markers, including maternal serum markers, to improve the accuracy for estimating risk of pre-eclampsia

• Uterine Artery Doppler (uAD) – The uterine artery Doppler can be evaluated by direct visualization, i.e. examining the characteristics of the waveform to determine if nothing is present or absent, or by quantifying the waveform by measuring the blood flow velocity at peak systole (maximal contraction of the heart) and peak diastole (maximal relaxation of the heart). These values are then computed to derive a ratio. The most common approach is to measure the Resistance Index (RI) in which the peak of systole is divided by the sum of systole and diastole

• RI= systole/ (systole + diastole)

• In early pregnancy the peak flow at diastole is less than later in pregnancy. Therefore, as the duration of pregnancy increases, the amount of blood flowing in the umbilical artery increases during diastole

 

Maternal Screening Solutions in association with PerkinElmer

CodeTest NameSampleComment/ Description

SGO61

Dual Marker Test:

(11 – 13.6 weeks) PAPP-A, Free ß hCG

2 ml serum / DBS Card

NT by USG report * (NT & CRL values) and brief clinical history required

SGO62

Triple Marker Test:

(15 – 21.6 weeks) AFP, β hCG , uE3

2 ml serum

USG report * and brief

clinical history required

SGO63

Quadruple Marker Test:

(15 – 21.6 weeks) AFP, β hCG , uE3, Inhibin – A

2 ml serum

USG report and brief

clinical history required

PRF2400

Integrated Test: Dual Marker (First Trimester Screening) & Quadruple Marker (Second Trimester Screening)

2 ml serum

NT by USG report in 1* trimester & USG report in 2nd trimester and brief clinical history required

Sequential Test: (Combined risk evaluation even if Dual Marker is done seperately)

SDO61

Dual Marker Test:

(11 – 13.6 weeks) PAPP-A, Free ß hCG

2 ml serum

NT by USG report * and brief clinical history required

SDO63

Quadruple Marker Test:

(15 – 21.6 weeks) AFP, ß hCG, uE3, Inhibin A

2 ml serum

USG report * and brief

clinical history required, (Patient needs to carry Dual Marker report)

SDO63

Prenatal BoBs TM

(Aneuploidies + Microdeletion)

3 ml Amniotic Fluid /

Chorionic Villi

Brief clinical history

required

SDO65

KaryoLite BoBs TM

Placental biopsy without blood clot in normal special container provided by Lab

Brief clinical history

required

*Latest Sonography report (USG) performed 1 month prior to blood test is accepted.

CENTRAL PROCESSING LAB

Aston, 2 nd Floor, Sundervan Complex, Opp. Union Bank, Above Mercedes Showroom, Andheri West, Mumbai – 400053

Book your appointment to do maternal screening.

Suburban Diagnostics Setting Higher Standards in Molecular Diagnostics

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HLA B27 By PCR

Used for confirmation of:

  • Ankylosing Spondylitis (AS), a rheumatic inflammatory disease
  • Reiters Syndrome
  • Anterior Uveitis
  • Improves sensitivity and specificity in diagnosis of (AS)
  • Detects only those HLA B27 subtypes that are associated with AS
  • HLA B27:06 and HLA B27:09, which are not associated with AS are not detected by this PCR
HLA B27 By PCR

Hepatitis B Virus Tests

Hepatitis B Virus Tests
  • HBsAg – used as a general marker of infection
  • HBsAb – used to document recovery and/or immunity to HBV infection
  • Anti HBcIgM – marker of acute infection
  • Anti HBclgG – past chronic infection
  • HBeAg – indicates active replication of virus and therefore infectiveness
  • Anti HBe – virus no longer replicating. However, the patient is still positive for Hepatitis
  • HBV DNA PCR – indicates active replication of virus, more accurate than HBeAg especially in cases of PCBC mutants

HBV Qualitative PCR

  • For confirmation of active HBV infection (genotype A-G)
  • Early detection of acute HBV infection: 4 weeks following infection and approximately 21 days before HBsAg can be detected in serum
  • Performed using Real Time PCR technology
  • Provides conclusive reports wherein serology provides equivocal/indeterminate results
  • To distinguish patients suffering from active infection and chronic carriers
  • Detection limit: For Serum, 6.7 IU/mL; for Plasma EDTA, 4.8 IU/mL
HBV Qualitative PCR

HIV-1 Drug Resistance

  • Identification of HIV-1 genotypic mutations associated with resistance to NRTI/NNRTI/PI
  • Genotypic drug resistance testing is preferred to phenotypic testing because of lower cost, faster TAT and greater sensitivity
  • HIV drug resistance helps in designing:
    1. Optimal treatment regimen prior to initiation of ART
    2. Change in ART regimen in case of treatment failure/relapse
  • Minimum Viral Load required to process the test >500 copies/mL
  • Two different panels available:
    1. Resistance to NRTI/NNRTI
    2. Resistance to NRTI/NNRTI/PI

NRTI : 3TC – Lamivudine | ABC – Abacavir | FTC – Emtricitabine | AZT – Zidovudine | D4T – Stavudine | DDI – Didanosine | TDF – Tenofovir | TDF – Tenofovir
NNRTI : EFV – Efavirenz | NVP – Nevirapine | ETR – Etravirine | RPV – Rilpivirine
PI : ATV – Atazanavir | IDV – Indinavir | LPV – Lopinavir | NFV – Nelfinavir | SQV – Saquinavir | TPV – Tipranavir | DRV – Darunavir | FPV – Fosamprenavir

 

HIV-1 Viral Load

  • Used in clinical management of HIV-1 infected patients
  • For monitoring patients on ART
  • Performed on US FDA approved COBAS TaqMan Real time PCR
  • Quantification of clinically significant HIV-1 groups O and M with full subtype coverage
  • Lower Quantification Limit (LQL) = 34 copies/mL
  • Broad dynamic range of 34 – 1 X 107 copies/mL

HBV Viral Load

  • Used in the management of patients with chronic HBV infection
  • Monitoring disease progression in chronic HBV infected patients and/or response to anti – HBV therapy
  • Performed on US FDA approved COBAS TaqMan Real time PCR
  • Ensures highly sensitive and accurate quantitation of all known HBV genotypes and pre-core mutant
  • Lower Quantification Limit (LQL) = 29 IU/mL
  • Broad dynamic range of 29 – 1.1 x 10 IU/mL

HBV Genotype

HBV Genotype
  • Hepatitis B Virus (HBV) infection is the leading cause of cirrhosis
  • Detects 10 HBV genotypes (A-J)
  • Clinical Indicators:
    1. Disease severity
    2. Likelihood of compli cations
    3. Response to interferon therapy
  • Minimum Viral Load required to process the test – 100 IU/mL

HIV-1 Qualitative PCR

  • Confirmatory test for diagnosis of HIV-1 infection (genotype A-H)
  • HIV-1 RNA can be detected 10 days prior to the appearance of both p24 antigen and HIV-1 antibody
  • Performed using Real Time PCR technology
  • Detection limit of 34 copies/mL
HIV-1 Qualitative PCR

TB PCR

TB PCR
  • Performed using Real Time PCR technology
  • Tests can be performed on:
    1. Pulmonary AFB smear negative
    2. Paucibacillary extra pulmonary TB (10-15% of all TB cases)
  • HIV co-infection
  • Targets IS6110 gene more prevalent in Indian population hence specificity is higher even in case of 1 bacilli

HBV Drug Resistance

  • Rapid and sensitive test for detection of mutations associated with resistance to Nucleotide Analogs (NA)
  • Drug Resistance determined for:
    1. Lamivudine
    2. Telbivudine
    3. Adefovir
    4. Tenofovir
    5. Entacavir
  • Minimum Viral Load required to process the test – 100 IU/mL
  • Nucleotide analogs like Entacavir and Tenofovir have high resistance barrier
  • In case of virological breakthrough, HBV genotypic resistance may be recommended
HBV Drug Resistance

Pre-Core & Basal-Core Promoter (PCBC)

  • Chronic HBV: 2 major forms – HBeAg positive and HBeAg negative
  • HBeAg negative patients possess mutations in pre-core and/or basal core region
  • Presence of A1762T and G1764A mutations in basal core region – decreases HBeAg production
  • Presence of G1896A mutation in the pre-core region results in complete loss of HBeAg production
  • 8 – 10% of HBeAg negative patients progress to cirrhosis and hepatocellular carcinoma

HCV Drug Resistance

HCV Drug Resistance
  • Determine resistance to NS5A inhibitors in HCV genotype 1a, 1b
  • Drug Resistance determined for:
    1. Daclatasvir
    2. Elbasvir
    3. Ledipasvir
    4. Ombitasvir
  • Viruses resistant to NS5A inhibitors are fit and remain dominant for many years, perhaps forever
  • Minimum Viral Load required to process the test – 100 IU/mL
  • As per the data of Poordad et al. Phase 3 ALLY-1 study. 201:
    • Only 76% of patients with HCV genotype 1a (n=34) achieved an SVR12
    • The pretreatment presence of NS5A resistance associated variants were the major reasons for the higher relapse rate in the 12 weeks
    • Hence, it is recommended to extend treatment to 24 weeks, addition of RBV may be considered

HCV Genotype

  • Detects all 6 genotypes and its subtypes
  • Sequencing facilitates identification and differentiation of subtype:
  • >> HCV genotype 1a, 1b
  • Identification of HCV genotype, aids in selection of most appropriate therapeutic regimen
  • Genotypes 1a and 1b have the poor clinical outcomes, hence precise subtype identification is important
  • In India, HCV genotype 1 and 3 are common
  • Minimum Viral Load required to process the test – 100 IU/mL

Hepatitis C Virus Tests

HCV Total Antibodies – Test positive after 4 weeks of infection

HCV IgM – Acute Marker for confirming the presence of Hepatitis C Virus

HCV RNA PCR – Confirmatory diagnosis of active HCV infection (targets all HCV genotypes)

Hepatitis C Virus Tests

HCV Qualitative PCR

HCV Qualitative PCR
  • Confirmatory test for diagnosis of HCV infection (genotype 1-6)
  • Distinguish patients suffering from active and past infection
  • Performed using Real Time PCR technology
  • Detection limit of 25 IU/mL

HCV Viral Load

  • Used in the management of patients with HCV infection
  • Predicting probability of Sustained Virologic Response (SVR) early during a course of antiviral therapy
  • Performed on US FDA approved COBAS TaqMan Real time PCR
  • Ensures accurate quantitation of HCV genotypes 1 through 6
  • Lower Quantification Limit (LQL) = 25 IU/mL
  • Broad dynamic range of 25 – 3.91×108 IU/mL
HCV Viral Load

Our Molecular Diagnostics Laboratory Features

  1. Among very few labs in India to provide State-of-the-Art technology
  2. 6 PCR Rooms, unidirectional work flow as per CLSI guidelines
  3. Bio safety level 2 diagnostics services
  4. Automated extraction for minimal manual intervention
  5. Real Time PCR technology for increased sensitivity and specificity
  6. US FDA and CE – IVD approved test as per international guidelines
  7. Mandatory use of internal controls in each sample to rule out false negativity

Molecular diagnostic tests timetable :

Test CodeTest NameScheduleTAT
MB001HBV Qualitative PCR/ DetectionMon/ Thu – 8amSame Day 7pm
MB011HBV Quantitative/ Viral loadMon/ Thu – 8amSame Day 7pm
PRF2377HBV Qualitative, Reflex HBV QuantitativeMon/ Thu – 8amSame Day 7pm
PRF2380HBV Viral Load & GenotypeMon/ Thu – 8amSat/Wed – 7pm
PRF2381HBV Viral Load, Genotype & Drug ResistanceMon/ Thu – 8amSat/Wed – 7pm
PRF2382HBV Treatment Response PanelMon/ Thu – 8amSat/Wed – 7pm
PRF2383HBV Mutation PanelMon/ Thu – 8amSat/Wed – 7pm
PRF2384HBe Antigen + HBV Taqman, Reflex to Pre-core and Basal-core promoter mutationMon/ Thu – 8amSat/Wed – 7pm
MB003HCV Qualitative PCR/ DetectionTue/ Fri – 8amSame Day 7pm
MB012HCV Quantitative/ Viral loadTue/ Fri – 8amSame Day 7pm
PRF2378HCV Qualitative, Reflex HCV QuantitativeTue/ Fri – 8amSame Day 7pm
PRF2385HCV Viral Load & GenotypeTue/ Thu – 8amMon/Wed – 7pm
PRF2386HCV Viral Load, Genotype & Drug ResistanceTue/ Thu – 8am15 days
MB010HIV Qualitative PCR/ DetectionWed/ Sat – 8amSame Day 7pm
MB013HIV Quantitative/ Viral loadWed/ Sat – 8amSame Day 7pm
PRF2379HIV Qualitative, Reflex HIV QuantitativeWed/ Sat – 8amSame Day 7pm
PRF2394HIV Drug Resistance Panel 1Wed/ Sat – 8am9 days
PRF2395HIV Drug Resistance Panel 2Wed/ Sat – 8am9 days
MB014HLA B27 by PCRMon/ Sat – 8amSame Day 7pm
MB008-09TB PCR/ MTB Detection TestDaily – 8amNext Day 7pm

Book your appointment today to take our precise molecular diagnostics tests.

ANCA and Anti-ds DNA Tests To Diagnose CVD & SLE

ANCA Blog Banner

ANCA

• Used in the diagnosis and management of Collagen Vascular Disease

• ANCA by IFA is highly sensitive

• c-ANCA (PR3) is increased in

  • Systemic Necrotizing Vasculitis
  • Wegener’s Granulomatosis
  • Churg Strauss Syndrome
C-ANCA

C-ANCA Pattern

• p-ANCA (MPO) is increased in

  • Connective Tissue Disease
  • Inflammatory Bowel Disease
  • Autoimmune Liver Disease
P-ANCA

P-ANCA Pattern

Anti-ds DNA

By NcX ELISA

• Essential in the diagnosis of SLE. It is also detected in patients with other autoimmune diseases

• Anti-dsDNA is significant for the prognosis of SLE & monitoring the disease activity

• Sensitivity in patients with SLE is 70%

• Specificity in patients with autoimmune diseases is 99%

 

Central Processing Lab
Aston, 2nd Floor, Sundervan Complex, Opp. Union Bank, Above Mercedes Showroom, Andheri West, Mumbai – 400053

Book your appointment to diagnose Collagen Vascular Disease & CLE at Suburban Diagnostics.

Tests To Cure Inflammatory Bowel Disease (IBD)

Calprotectin Banner

Calprotectin : Differentiation between IBD and IBS

• About 20% of patients with recurrent, non-specific gastrointestinal symptoms suffer from Inflammatory Bowel Disease (IBD)

Calprotectin assures high clinical value
• High sensitivity 97.7%     • Positive Predictive Value (PPV) 0.96
• High specificity 89.8%     • Negative Predictive Value (NPV) 0.95

• Calprotectin minimizes the number of false positive results and reduces the number of unneccesary biopsies

• For monitoring disease activity and for a prediction of relapse during clinical remission

• In recent studies, it was possible to predict relapse in Crohn’s disease and ulcerative colitis.1, 2

Algorithm

1. Tibble JA et al (2000). Surrogate markers of intestinal inflammation are predictive of relapse in patients with inflammatory bowel disease. Gastroenterology 119: 15-22
2. D’Inca R et al (2005). Can Calprotectin predict relapse in inflammatory bowel disease? Gastroenterology 128 (suppl): A307

Helicobacter Pylori

Helicobacter Pylori

Helicobacter pylori (H. pylori) is associated with
• Peptic Ulcer     • Chronic Gastritis
• Duodenitis     • Gastritic Cancer

• In patients with gastritis, eradication of bacteria leads to healing of anatomical lesion

• IgG levels rise with infection and remain constantly high until the infection is eliminated

• Efficacy of Antimicrobial therapy can be monitored with changes in specific antibodies

• As IgA levels decrease more rapidly than IgG, this parameter can be useful in follow-up of patients

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CENTRAL PROCESSING LAB
Aston, 2nd floor, Sundervan Complex, Opp. Union Bank, Above Mercedes Showroom, Andheri West, Mumbai – 400053

Book your appointment to take Calprotectine or Helicobacter Pylori test at Suburban Diagnostics.