qci_lab
Our laboratory at Providence provides a complete array of hormonal and biochemical tests. The state-of-art laboratory is in line with international standards with utmost accuracy in the fastest possible turnaround time. The laboratory area is exquisitely designed for the purpose and confers to standard practices in biomedical waste management. The fast turn around times ensure that our guests don’t need to wait for long before critical reports are generated.

The laboratory is certified by the NABH under the medical laboratory program. We are involved in external quality assessment program with Bio-Rad (USA) and CMC Vellore, in addition to interlab quality comparisons. Internal check lists for ensure that all discordant results are again re-checked. We use Laboratory Information Software (LIS) to avoid human errors in reporting.

laboratory

Phlebotomy: Our experienced phlebotomists are key members of the laboratory team. They are involved in collection of samples and transportation of blood samples. Most of our phlebotomists have more than 5 years’ experience in phlebotomy and laboratory technology.

Core Laboratory: Staffed by highly qualified biochemist and laboratory technicians, the clinical laboratory at Providence regularly doses hormonal tests and biochemical tests. We also outsource tests to reputed laboratories including Gene path (for genetic studies) and Quest (for rare hormonal tests). We use state of the art laboratory equipment for testing

  1. Hormonal tests: Cobas e 411
  2. Biochemistry: Cobas c 111, Selectra ProS
  3. Haematology: Medonic
  4. Electrolyte Analyser: InnoLyte
  5. Biorad D10: HbA1c
  6. Urine analysis: Urisys1100

All biochemical tests are done in imported machines and follows a strict internal and external quality control.

C111 Roche Fully Automated Chemistry Analyzer: This is a fully automated bench top chemistry analyzer. From pipetting to final reports being done on a continuous analyses with Roche proprietary reagents, there is no room for error.

Alfa Wasserman Starlyte III analyser: Electrolyte analyzer by ion-specific electrodes. (Germany)

ELECSYS 2010: Manufactured by Roche, Germany, ELECSYS 2010 uses electro chemilumniscence system for hormonal analysis. This machine can process all the hormonal investigations with a rapid turnaround time. Electrochemilumniscence is the gold standard technology for commercial hormonal analysis.

Biorad D10: This machine this is the Gold Standard method for HbA1c and is done by HPLC. Turbo Chem.: this is a fully automated random access biochemistry analyzer by Awareness Technologies, USA.

Medonic 3 part cell counter: 3 part differential cell counter for hematology (Italy)

Roche Urisys 1100 Urine analyzer: automated testing of urine samples for various parameters
The laboratory runs daily internal quality controls and also takes part regularly in EQAS by Biorad, USA and CMC Vellore for biochemistry and hormones. The laboratory confers to the Essential Standards for Medical Laboratories by the Quality Council of India (QCI) which covers internal quality checks, external quality checks, proficiency testing and reporting.

Instructions to patients for sample collection

  1. If you have any doubts of sample collection timings in relation to food (fasting or post prandial), please discuss with the phlebotomist
  2. When we ask you to come fasting, it means around 8 hours without food and drinks. You may have plain water
  3. Post prandial is technically 2 hours after the start of a meal.
  4. Certain samples like FSH/LH etc are preferably collected in relation to menstrual cycle timings
  5. Preferably wear a half-sleeved shirt when you come for sampling. This is to avoid minor blood leaks that may occur after sampling
  6. Hold the cotton on the needle site for 2 minutes before you release it for adhesive plaster application.
  7. If you are using blood thinning agents (e.g. Aspirin, Clopidogrel, Pradaxa), please inform the phlebotomist. You will need to inform the phlebotomist and make sure that you hold the cotton for 5 minutes before an adhesive plaster is applied.
  8. If you have a favourite vein, please inform the phlebotomist. You know your veins better.
  9. If it is generally difficult to sample your blood, please inform the phlebotomist. We can use a butterfly needle device for sampling. Drinking plenty of water before the sampling and clenching of fists repeatedly can help improving successful phlebotomy rates.

Timing: The laboratory functions from 7 AM to 5 PM on week days and from 7 AM to 12 Noon on Sunday.

What is reference range ?
A reference range is a set of values that includes upper and lower limits of a lab test based on a group of otherwise healthy people. The is determined by the manufacturer of the machine using a method. This may differ between populations, if a different method is used or a different reference population is used( e.g triglycerides levels may be high if the refernce population contains more obese people than another reference population that contains more lean people)

The reference range may change when the method is changed

The reference range may change if the population is changed. E.g the upper level of TSH in pregnant reference population is different from the upper level of TSH for 60 + year old women.

Note
1.Not all values above or below the reference ranges are abnormal
2.Not all values outside range require treatment
3.The decision to treat will depend on clinical history, examination, associated investigations, medications and a host of other factors used by healthcare providers in decision making.


What is Target range ?

The target range does not need to be related to the reference range. It is within these range of values the physician aims to bring the values of the patient to, so that he/she has the best outcomes. It may vary according to patient characteristics.

e.g. a 30 year old diabetes subject can have a target HbA1c of less than 6.5 % whereas the target range fo HbA1c in a 75 year old subject with diabetes and kidney failure may be 8 %. The reference range for HbA1c is 4-5.6 % for the lab.

Methods of assaying
Different labs may use different methods of assaying. This can lead to various normal reference ranges for tests. E.g TSH may be done by radioimmunoassay ( RIA) or electrochemilumniscence( ECLIA). The normal ranges of these tests are different.

Optimal time of collection
The optimum time of collection of different tests is different. This is because some hormones have a diurnal variation and some are affected by food. e.g cortisol is collected by 8 AM in fasting state. Some hormones may be collected in certain time periods of the menstrual cycle.

INTREPRTETATION OF LABORATORT TESTS

FPG (fasting plasma sugar)
Reference range: 70-100 mg/dl
Method: GOD-POD /Hexokinase
Time of collection: 8 hours of overnight fasting
Elevated blood sugars are elevated in various forms of diabetes including type 2 diabetes, type 1 diabetes, gestational diabetes and pancreatic diabetes. One single elevated value does not suggest diabetes in the absence of symptoms of diabetes. For diagnosis of gestational diabetes, one elevated FPG value above 92 mg/dl may suffice.

Low fasting blood sugars may be associated with exogenous insulin or anti-diabetes drugs, insulinomas, adrenal insufficiency, hypopituitarism etc. . FPG less than 70 mg/dl may not always suggest disease states unless associated with symptoms. Although we mostly say “ blood sugar”, what we measure is “ plasma sugar” .

Related section: diagnosis of diabetes


Post prandial plasma glucose

  1. Reference range: 140 mg/dl
  2. Method: GOD-POD/Hexokinase
  3. Time of collection: 2 hours after the onset of the meal

Comments: Elevated post prandial sugars are seen in subjects with various forms of diabetes. The maximum value of PPG is less than 140 mg/dl. Although the time of peak value of blood sugars after the meal may vary between individuals and after various meals, the timing is standardized as 2 hours in subjects with diabetes and healthy individuals. 1 hour PPG may be measured in gestational diabetes. The PPG targets in subjects with diabetes will be decided by treating physician based on various factors.

Related section: diagnosis of diabetes


HbA1c (Glycosylated hemoglobin)

    Reference range:

  1. Normal: 4.0-5.6 %
  2. Prediabetes: 5.7-6.4%
  3. Diabetes ≥ 6.5%
  4. Method: HPLC ( High Performance Liquid Chromatography)

Time of collection: any time irrespective of time of day and meal
Comments: HbA1c is an integrated measure of the blood sugar levels over the preceding 3-4 months. Values > 6.5 % are suggestive of diabetes mellitus. There are a host of factors affecting HbA1c including hemoglobinopathies, liver disease, kidney disease, drugs, iron deficiency anemia, triglyceride levels etc. HbA1c levels are also method dependent and HPLC is one of the most accurate methods for HbA1c determination.

Providence reports HbA1c in %, as mmol/L and also as estimated average glucose (eAG) in accordance with internationally accepted practices. eAG helps reporting HbA1c in an easily understandable format.  So if your HbA1c test result is 6.5 % then your eAG is 140 mg/dL .This means your average blood sugar level over the past 2-3 months comes to 140 mg/dL.

Related section: diagnosis of diabetes


Lipid profile
Reference range: The reference ranges of various components of lipid profile can vary between populations

  1. Method:
  2. Cholesterol: CHOD- POD
  3. Triglyceride: Enzymatic, end point
  4. HDL: Direct measure
  5. LDL: Direct measure

Reference range: The reference ranges of various components of lipid profile can vary between populations

  1. Cholesterol: Desirable <200mg/dl
  2. Borderline High: 200-239 mg/dl
  3. High Risk:>240 mg/dl
    Triglyceride: <100mg/dl: Optimal
  1. 101-150:Normal
  2. 150-199: Borderline
  3. 240-499:High
  4. ≥ 500:Very High
    1. HDL: Female: >50mg/dl, Male:>40mg/dl

    2. LDL < 100 mg/dl : normal
    3. 100-129: Acceptable
    4. 130-159: : borderline high
    5. 160-189 : high
    6. 190 : very high

    Time of collection: lipid profile is ideally done after 8-10 hours of overnight fasting. Triglyceride component of the lipid profile is heavily influenced by food intake. It is prfereble to avoid alcohol, high fat and carbohydrates on the day prior to testing.

    Comments: High levels of LDL levels are associated with increased risk of atherosclerotic vascular disease ( heart diseas and stroke).

    The total cholesterol and LDL component of lipid profile can elevated above upper limits of normal in various forms of inherited and acquired disorders. Various conditions like hypothyroidism, nephrotic syndrome( kidney disease), Cushing’s disease, drugs like corticosteroids, beta blockers and cyclosporine etc. High cholesterol and LDL may be found also in obesity, diabetes mellitus, people with sedentary lifestyles.

    High triglycerides may be seen in various inherited diseases of triglyceride metabolism which run in families. It may also be elevated in hypothyroidism, nephrotic syndrome( kidney disease), drugs like anti psychotics, estrogen, tamoxifen, thiazides etc. High triglycerides may be seen after ingestion of alcohol and fatty meal.

    Important
    1. The decision to treat an individual with high LDL or cholesterol level is based on risk of developing a disease e.g a 20 year old lady with LDL of 120 with no other risk factors for heart disease does not require treatment where as a 45 year old diabetic with LDL of 120 should be treated with statins.

    2. The LDL levels are sometimes derived by calculation. This is not valid when TG levels are greater than 400 mg/dl.


    Creatinine

      Reference range:

    1. Males:0.6-1.4 mg/dl
    2. Females : 0.5-1.2 mg/dl

    Method: Jaffe−kinetic
    Time of collection: any time irrespective of time of day and meal
    Comments : Creatinine is a test of kidney function. In subjects with varying degrees of kidney dysfunction, the creatinine increases in the blood. However, significant kidney disease may be present even with a normal creatinine. Creatinine may be elevated due to kidney disease or due to various drugs e.g fenofibrate, Septran( Bactrim), Cemetidine).

    Creatinine may be used to calculate eGFR ( estimated glomerular filtration rate). Blood levels of creatinine may not increase above the normal reference ranges despite significant impairment of kidney function. However, even these small changes in renal function will be reflected in the eGFR calculation. eGFR is calculated by various equations, the commonest of which is CKD-EPI equation which uses creatinine, age, sex and race.

    Normal eGFR > 90 ml/min/1.73 m2


    Sodium

    1. Reference range: 135-148 mEq/L

    Method: ISE Direct

    Time of collection: any time irrespective of time of day and meal
    Comments : sodium is an important ion that circulates in the blood and also a part of all cells. An elevated serum sodium level is called hypernatremia while decreased levels are called hyponatremia. Low sodium can cause confusion, memory loss, fatigue and even coma if untreated. Low sodium is associated with diarrhea, vomiting, diuretics, SIADH, hypothyroidism, adrenal insufficiency, heart failure, kidney failure, liver failure etc. High sodium levels are found in dehydration, diabetes insipidus an hyperaldosteronism.

    It is important to carefully investigate all patients with sodium related disorders as there may be potentially serious underlying diseases.


    Potassium ( K)

    1. Reference range:3.5-5.3 mEq/L

    Method: ISE Direct
    Time of collection: any time irrespective of time of day and meal
    Comments : Potassium is an important ion that circulates in blood and is also a part of all cells. Elevated K is called hyperkalemia and low potassium levels are called hypokalemia. Hyperkalemia can be due to kidney disease, adrenal insufficiency and certain drugs. Hypokalemia can be due to drugs like diuretics, recurrent vomiting, diarrhea, Cushing’s syndrome, Conn’s syndrome etc. Sometimes the sample can be lysed and K+ maybe falsely elevated.

    Liver function tests

    The LFT are a series of tests that test various aspects of the liver function. The various components of the liver function may signify various diseases beyond the liver.

    Bilirubin: total and direct. The bilirubin comes from the breakdown of red blood cells and it is seen in the blood. It is taken up by the liver and excreted out of the body. The levels of bilirubin may be elevated in liver disease, hemolysis ( when there is rapid breakdown of RBC) and Glibert’s syndrome.
    Reference range: Total Bilirubin: Up to1.1mg/dl, Direct Bilirubin:Up to 0.3 mg/dl
    Method : Total Bilirubin: Diazonium Ion, Direct Bilirubin: Diazotization


    SGOT and SGPT: these are called as transaminases. The levels of transaminases go up when there is liver injury. Very high levels are found in acute hepatitis, drug induced liver disease, and alcoholic hepatitis. Moderate elevation may be seen in NASH ( which follows fatty liver), certain viral illness, pancreatic disease and alcoholic liver disease.
    Reference range: SGOT:

    1. Male: up to 40 U/L, Female: up to 32U/L
    2. SGPT: Male: Up to 41U/L, Female: Up to 33U/L
    3. Method : UV without P5P

    Alkaline phosphatase : it is elevated in obstructive liver disease including certain drugs. Common causes include obstruction to bile flow ( e.g carcinoma head of pancreas), biliary cirrhosis, estrogen, tamoxifen etc. However, it can be elevated in diseases of the bone and intestine also.
    Reference range:

    1. Male: 40-129 U/L, Female: 35-105 U/L
    2. Age: 1 day:<250U/L , 4-6yrs:<269
    3. Age 2-5 days:<231, 7-12yrs:<300
    4. Age: 6days-6 month:<449, 13-17yrs(F):<187
    5. 7month-1year:<462, 3-17yrs(M):<390
    6. 1-3yrs:<281

    Method : PNPP, AMP Buffer


    T Protein and Albumin
    Reference range:

    1. Albumin: 3.5-5.2 gm/dl
    2. T. Protein: 6.6-8.7 gm/dl
    3. Albumin/Globulin ratio: 0.8-2.0
    4. Method: Albumin: Bromcresol Green (BCG)
    5. Globulin: Calculation
    6. T. Protein: Biuret

    Time of collection: any time irrespective of time of day and meal
    Comments : Albumin is a protein made in the liver. It circulates in the blood carrying various substances attached to it like thyroid hormones , vitamins , drugs and calcium. The blood has other proteins also like globulin, fibrinogen, lipoproteins and clotting factors. But albumin is the most abundant protein in the blood.

    Albumin is reduced in 2 major conditions : when the production is reduced (liver disease, malnutrition) and when it is lost from the body(kidney disease, chronic intestinal diseases). Globulin is another important protein in the blood and consists of alfa, beta and gamma globulin.

    Total globulins may be increased in some chronic inflammatory diseases (e.g TB) , multiple myeloma, collagen disease, and rheumatoid arthritis.  Decreased levels are seen in liver diseases, kidney disease and various cancers. A/G ratio is a common measurement that may suggest a disease state. It is not specific as the A/G ratio may be reduced by a low albumin or elevated globulin.