testing and calibration laboratories - pathcare labs€¦ · national accreditation board for...

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National Accreditation Board for Testing and Calibration Laboratories (A Constituent Board of Quality Council of India)

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SCOPE OF ACCREDITATION

Laboratory PathCare Labs Private Limited Survey No 34 Cheeryal Village Keesara Mandai Greater Hyderabad Telangana

Accreditation Standard ISO 15189 2012

Certificate Number MC-2197 (in lieu of M-D541) of 16

Validity 09072017 to 08072019 Last Amended on

CLINICAL BIOCHEMISTRY

1_=L~erum [ 25 - Hydroxy Vitamin 0 [ CLiA ~~-------- [42to i56ngmL- -r~~~-l 2 [Serum --1 AlanineTransa-rliinase-[ UV with P5P----------- Tiiio1666uC i 90 i

1I ~(ALTSGPT)---L-~ ___ __ _ ~ __ _3 [Serum [~~umin I Bromocresol purple _ ~ 6 to ~ gdL _ _ L~~Cl i 4 i Serum Alkaline PhosPhataslPNPp-AMP Buffer 10 to 1000 UL i 100 i

[ I (ALP) i I +-=~~~--- -------- ------ _ _ ------------_

5 [Serum i Alpha 1- Antitrypsin Ilmmunoturbidimetry 022 to 60 giL 90

6-1 Serum i i~~ Feto protein~CL~----1624i()363 ngmL --r9C)----1 [ I (AFP) i _ _~__~___

j--TSerum------------l--Amylase-Serum----1 CNPG3[6io650 UL i-so __L-- -l~ ~_+ -----~-------------- __- ------------- --- j-- _ _bullbullbull ~

8 Serum Anti Streptolysin deg i Immunoturbidimetry 20 to 600 IUmL i 70 I-J-------I (ASOL J L -- --- --1- -middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddot--i

9 i Serum i Aspartate I UV with P5P [ 0 to 1000 UL i 95 l I Aminotransferase i i (SGOT) i ------+---=------------t--------- ---j~~---~--------------j_------------------------- -----1----------middot--------------1

bull 10 Serum Beta- Human CLiA 20 to 1000 mlUmL 100 II

Chorionic [ [i I I 1

I Gonodotropin i j i i iiiHormone i I-if-rserum-----------Bilirubin-Oirect----------joiazoifZation--1 605 to 16 mgdL-i-122-- i [12--LSerum _rB(li~~i)i~T~~r~ct~-~~~L~~~~I~~=====-Lt--JA bullbullbull bullbullbullbullmiddotmiddotmiddoti~~=~-~=j i i3-- -Serum ---- i Bilirubin Total i Diazotization i 01 to 25 mgdL i 100 li4 i Serummiddot----- i Blood Urea-Nitrogen-urease-GLDH--------------1tO-156 mgdL 19o-i ~UN) J________J j 15 i Urine I Blood Urea Nitrogen l Urease GLDH 1 1 to 150 mgdL -_-_-_-_i 9~O i i I _-L (BUN)~ __ ___ ----------- --1iLL

~c~ Devaki Devi Mandava Dr Vandana Jain

Convenor Program Director


ItflBL




Certificate Number MC-2197 (in lieu ofM-0541) Page 2 of16


scr~r~~~i~~~f T~~~~~~eTdest-- ----rest Method -~------- r~i~~i6f~~~0~--CVOlo- j

lTe~_t~ i L ~______ 1__ 1_____]

[ 16-1 Serum-------~---i CA125---------------i-CUA--------------------- -nt0500 UmC--102- ---I [17-Ts-erum-----i cAi53---------------i--c[TA-------------------1i- to 300 Um Lr90--

t1li~ru~---~E~~--==-------t~-[I~---=--==-=~==--==i~0_i06~UjrT1C-ll~~j 19 i Serum Calcium i O-cresolphthalein [ 5 to 15 mgdL 80 ii

[ i complexon (OCPC) ___ L __~ L ~_______ - - bullbull -------------------~------- -- - ------- J------- ----1 20 i Urine i Calcium i O-cresolphthalein i 5 to 15 mgdL i 90

i--j--------------L--~-----------j complexon (OCPltL_____L ----- -- -- i-- --Ii 21 i Serum I Carcino Embryonic I CLiA i 015 to 550 ngmL [ 115 i i IAntigen (CEA) i i t 2i-t~~um-= _4_lt~_~~2la~~In----i~-I11~~O-u-rii-=metry~=-=1~sect3to_1-~-gf- j_2~E i 23 i Serum Chloride i ISE DIRECT i 50 to 140 mmolL i 90 [2~ I~ine --==-L~~~~~ltf~===___=_l1JE~~~cX---==~-=Tlot~~5~mmoilL~~~~Ji 25 1 Serum Cholesterol - HDL i Direct Homogenous 0310 150 mgdL i 90 i i~_L~~~um ----1 ChOlesteroT__~~~~~=-=rcarcUi8ted-------~=rmiddotNAmiddotmiddotmiddot - --~- (NA---i

i~7middot_i SllIum _~_~ Ch~~~~~~_~~~_ __L~H0PAP j50~5001Tl9ldL middotmiddotmiddot-r-o-~ 28 i Serum I Cholesterol VLDL Calculated iNA i NA i [i9-TSerum --------iComplem-ent3(C3j-Ttmm-umiddotnoturbid-imetry----1064105oglmiddotmiddot middotmiddotmiddotmiddotmiddot-T9middot0---1 f middotmiddotmiddot-------+-------------------t~----------------middot +--------------------------~-------1-middot-----------_middot-middot --__-_ -- _- -1---------middotmiddotmiddotmiddotmiddot middotmiddot-i

l 30__ ~~~r~-r--------__l Complement 4 (C4L -rnrn_~_r~_u_~~~~rn~tI i_~tJ2 to 10gL )-100_31 [ Serum [ Cortisol I CLiA [ 020-75 ~gdL [ 120 i -1-____ -+_~__~ ~ ________1 ~ 1 middotmiddot __ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddot middotmiddot_ _ - ---__- ----1

i 32 Serum i C-Peptide i CLiA i 005-30 ngmL [ 100 i

I33-Tserum T~~~~ctivemiddotprote-in---Tlmmunolurbidimetry---116 to 250 mgj[_J-~~_J

i3~_ __ l~~~r _==middot-C~~~~nJ~~~==~~=]=J affEl-Kinetic--~~====-~=IOi~=~(jrrgj~L l-~s--i i 35 Urine Creatinine i Jaffe Kinetic i 5 to 400 mgdL i 90 i l I -i-----------------------J---------------------------------- ------ _ - _ _ - --j--------- ------j

i 36 i Serum I Dehydroepian- i CLiA i 15 to 1000 ~gdL [ 12 0 I drosterone Sulphate i imiddot

i i (DHEA-S) i3i~-iserum-------------t-Estrad ioneE-iT middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddot-~Ic CIA-===_-~_~~_Li1~tO~~~OEgirTIL middotT12~Omiddot-j i3s-rserum-----1 EstrioilJrlconfugated i CLiA l 007 to 12 ngmL -1-io -- j ~ Ll_~~2_______ _ __ l __~_ l ___ J

~o~middot Devaki Devi Mandava Dr Vandana Jain


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rtABL




Certificate Number MC-2197 (in lieu ofM-0541) Page 3 of 16


siTprodUcl--Specifj-cTest ---------- i TestMethod -~---TRange of Testing liev----middot I Material of i Performed i i Lim its of Detection Test iii __ L----~-----------------__--------------------~-~-------------__ - -

39-TS-erum----~--[-FerritTn------------------TCuA----------~----T0410 1500 ngmL -111--7 i 4o-iSerum-----~Folate-Serum~----ic~~~----~--------i-63510Z4 ngmLmiddotmiddotmiddotmiddot 112-0 --i (Folic Acid) j[ 41~TSerum~---------pofljcleStim-ul-aiin-g----T CLIA-------- ---T6~3toioomilJmL-i-120--[ I iii Hormone (FSH) i i _L___ 4CTSerum--~----neeUie-C-hains---------lr-imm-u-noturbidTmetry-----T1 10 1ZgiL - i 80

I I I

l L_ j KapJa_____ i __ L _ L i 43 Serum I Free Lite Chains i Immunoturbidimetry 05 to 75 giL i 90 j

i JLambda Iii i 44--1-serum--~ GammaGluiam0------i--TFCCGCNA----------- --I 0 to 800LJL iio---II

i Transferase iii j

I

(GGT) I Iii j 45TSerum-------Giobulin------------rCalc-ulated---------- - TNAiNA 4Ei--rNaF-PlasmaT------jGiiicose-----------------jHexoiltinas-e------------------ i 0 -- 500 mgdL -- i921 i IAsciticPleural1 iii

47--- i ~~~~~~~~~~~--j--GI~C~se-=-~~_~~=~_~--J-~~~~~~~~~~~-======-~t(_500~9cJL j~~~= i 48 i WB - EDTA Glycosylated i HPLC i 37 to 184 i 90 i

I i Hemoglobin i i i (GHbHbA1c) [ i i

4ii---j Serum----~ Growth Hormone(GHn CLlA-------------------------i 005 to 40 riglmL LBcCl_j i5O-Tserum--~-ifiaptoglobin --------fmmu-nolurbiCi-imetry--------r ci 1 to 57 giL i 90 15TTSerum --------------ngE-Tolai------------l CLlA--middot~-~~-----Tii02666ILJmL 99- i 5ifSerum -~----------rlm-mu-riogTobulinA---Tmmunoturbidi-m-eliY----[05 9-0-1to 80 giL I

i I (lgA) i i 53--1 Serum ~---rlm-muri-ogiotulin-G-_rjmmunolurbiCi-i-m-ety------13 to 50 giL middot--190-j

I j (lgG) iii i 54--r Serum----------pm-munoglobulinM-----i ImmunoluriiiCiTmelry------- 025 to 65 giL middotmiddotii6~ci---i

i i (lgM) iii i nnsUli-n---------------j--CLiA~---------------------i65 to 300muiC -i16~1----j

_____55Tserum

_~L __ _ -- -------

~C~ Devaki Devi Mandava Dr Vandana Jain


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rtABL






SI~TProductI -----lSpecificTesf~-------n est-Method------- TRange of Testing-rcvo----

I__ ~tial of performed L ~ __ L~imits ofDetetin J I

~~-t ~i~--m--~r~~~a~~~~~c~t~t~~~~r==~==-=-=-=I~~o1~ggt~~~~L ---=1~-1 i 58--i Serum Tiron Saturation (o) CaTculated-----------------[NA-- -rJA ~i

59- -Serum --I-~~t~~ogena~~~~)-T~y~~v~t~Lactateto--~- 1-6t01-000 UL - - -193--- 60 i AsciticPleuraITtLactate--------------i-IFCC UV-Lactate-to--------- 6t01000 uiC - ----T93

i Synovial Fluid Dehydrogenase (LDH) i Pyruvate i _ l----- bull -------- -- - --_------ _------------- ------ --- --- ----- ____ _ _ 1

61 Serum 1 Lipase Enzymatic ColorimetriC 10 to 1500 UL i 11 0 - --------------------------------------------------------------------- ---- ------------------- - --- - - l----middot---- --1 62 Serum I Luteinlsing Hormone CLiA i 007 to 200 mlUmL i 106 I

16i-+serum-----------I-t~neslum--~ [Methyllhymoi-Biue----- 16-to 26mgiCjC--j 80--------1

l6~=~Qi-in~==~~=~ ____l~~-~n esIu_m----------J MethyTihYmolBlue__~==i6-t02omgdC-middotmiddotmiddot --I8~==i 65 TU~~E ~L~croaiiJumiro~_l~nmunotl_rlJiJ~~trx____l 3 to 300mgL_ L~g j i 66 Serum Osmolality Calculated NA NA iI

[~ TDi-Tne---+~sm~~~i=~===I~~~-~-~~~-~-==~-==rHE __ n~_ n~~_~~=-l i 68 I Serum Phenytoin (Eptoin) I CLiA i 05 to 40 ~gmL I 110 i L ----------- bull __ __ bull _ middot middotmiddot middotmiddotmiddot __ middot_middot -- bull

i 69 Serum Phosphorus UV-Phospho molybdate j 051090 mgdL 87 _1

I 1 _bull____ _ - -- -------- ----- - - ---lt _ __

I 70 Urine Phosphorus ~

UV-Phospho molybdate 05 to 90 mgdL 80 f -71 I Serum I Potassium ----~---~IISE Dlrect~---~--~ 15 to 1-0 mmollL 19-6~--j f bullbullbullbullbull---- I -------~--------------------- -j------------------------------- I - -- - - 1----- -middotmiddot-------1 72 I Urine Potassium liSE Direct I 1 to 100 mmollL i 80 Il __l L l __ --- -_ l l

I 73 I Serum i Progesterone CLiA 021 to 60 ngmL 1122 bull ---__---l- bull bull ~ ------------------------~--------------------- --- - ------- --------------- ---------- - ------~--_ bull___ --- - --

74_ I Serum Prolactin CLiA 03 to 200 ngmL I 118 i t -----1-----~---_____+---------------------------1--------------------------------------------- ------------ ------- -- -- -------------- --- ------- -- -- --i----- - - 75 Serum Prostate Specific CLiA 007 to 25 ngmL I 90 Antigen (Free) [-76--1 Serum -- j Prostate specific-----lc-liemiiumiriescence-----j6(11 to 1()O-ngmL-j116j

1 l l Antigen (Total PSA) I I I --t-n-----------------------------~----~~----~------- ---- ---------------- ---------- - 77 I Urine ICSF Protein I Pyrogallol Red i 6 to 250 mgdL 70 i middotmiddot-----middot--+----------middot-------------middot-1-middot------------~----------middot---------------------l------------------------------- ----- - ------ ------178 I Serum Protein Electrophoresis Albumin 1 LOD-03 gdL l 40 __L J_0g~~selt3e~L_J ~__ ~~___ Ij

~tc~ DevakiDeviMandava Dr Vandana Jain


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51 I ~r~~~~~ ~f------] ~~~~~~~est~---r Test Method-------T~i~i~~b~~~~~---iCVOj--

i Test i ~i L ___J _




tlflBL QCI






5-11Productl -----Tspecif(c Tesf~----------rTest Method~-rRage atTesting j - i-cvol~--

i Material of IPerformed i i Limits of Detection LI~S _ i __1 t__ _ _l_~

CLINICAL PATHOLOGY

~r~ Devaki Devi Mandava Dr Vandana Jain



HABL QCI


Laboratory PathCare Labs Private Limited Survey No 34 Cheeryal Village Keesara MandaI Greater Hyderabad Telangana


Certificate Number MC-2197 (in lieu of M-0541) Page 7 of 16


SCproduct-r-----rspe-cTticTlist--------rTest M-eth-(d-----~----TRange of Testin-g -- - (i-7shyI Material of Performed i i Limits of Detection

__1~~ L 1

HAEMATOLOGY amp IMMUNOHAEMATOLOGY

i---rWB-EDTA -------AbsoIUle-Eosinophil--NeubauerC-ouiiWng--- O-Pctuaicouniimm-r NA-----shy I Count Chamber

T i~~-ED~~I~~~~I~te Reti-cuiocyte---T~~~~~~e~n~_~I~~_~~~~nI~~~~ _ _ _I_~~------I 3 EDTAamp Serum Blood Grouping i Tube Agglutination Method I ABABO i NA iI

- CfWEfEDTA----tk~o~dOb-fcf~r~I~p-e - Ceishman-Stalnamp-- +~ritive lNegative___ijfA i Peripheral Smear i Microscopy i i

l Examination I I i j ~~_ -wElEDTA--rCl_~~lJE~gI=J--Tmm-unofiourocent-- -6~i6o_ - j49~ __ j

6 WB-EDTA I Complete Blood Count Cell Impedance 1 NA i NA i

--- I Ug_~gL l MicroscoeY 1__ j NA-----j

-t--I~~~~~~---i-secte~n~i1P~kr~~i~L1middot~-fc~~s1~~~=--Ibullbullmiddot~iim~~ ~~~pound~~ -- middot-_T~~-middotmiddot~- -1o+PieuraiAscitiCj ~~yencf~~~~~---- --[-Neubauer Counting --hNiTio actuai count -NA j

Synovial i Chamber f Microscopy I mm 3 ) i

Pericardial i i

H-I ~~t~~e~~t71 Fluidcelicouni--------Neu-bauerCDunting-------I(Nii to actual couni-+NA m_j

i Synovial I i Chamber mm) il iI

Pericardia _2~itoneaJ-CSF-i---------------------------L----------------------------------------1 J j

1_~_ i _WB-EDTA _---JIemQgclbin~ ___~l~yDsectthrv1ethod iOto 25 (gfdL) -j i 13WB-EDTA I Hemoglobin Variant HPLC i HbA2 [ 127

i Estimation bymiddot i HbF i 82

14 I WB~EDTA---JI- ~~~i~i~~e------l MTcroscopy--- --- tive Negabve-- i~middotf

_j ~ J_ Identifictisgt~__ __ _L _

~o~ DevakiDeviMandava Dr Vandana Jain



rtflBL QCI






81 1~~~~i~Y~middotmiddotmiddot---r ~~~~i~~esC---middot Test Method---- ---T~i~~~f~~~~~middotmiddotmiddotCvo7~middot--1I I Test I L__ __L ____ I

15 WB-EDTA middotmiddot-1 Packed CellVollJnie middotmiddoticell Counler--middot----i-NA ----4--a--middotmiddot-l

__l-- ----------JJPCVL---- lJ9lc~ation )------------g hi- ~lVI~EDTA ~-PItelet Count (P~L__L~mpedan~--------_0~lllll(10 ~) _ _ 17 i WB-EDTA I RBC Count I Cell counter I 00 -80 (10 IL) i 23 I -~ _middot__middot__1 -JjJ1PElcsect~_lte~_I1II~th2CL_L -1- 18 WB-EDTA Retic Count i New Methylene Blue i NA I NA

I I

I Staining And Microscopic i iI I I I Examination

i9~T WB-EDTAmiddot--1Sfc-klfng-TesCmiddot---~i6eoxygenation I middotmiddotTposfiive7 Negative - imiddotNA _

20+WS-EDTA ITotalLeucocyte count-+~~~f~~-crmce ----middot--O()999(166lTj-26----j I i (TLC) I Microscopy I I

DevakiDeviMandava Dr Vandana Jain Convenor Program Director


rtflBL






1 Body Fluids Tissue Pus Sputum Tracheal Secretion

___-lET Secretion 2 i Body Fluids

Tissue Pus Sputum Tracheal Secretion ET Secretion Urine

3 Body Fluids I Pus Tissue

Sputum Pus Urine ET Secretion Tracheal

i Secretion i 4~-+~B~lo-=od

-- -------------shy5 Blood

MICROBIOLOGY amp SEROLOGY

i AFB Culture ----------r Aerobic Culture Qualitativei Fluorescent Detection

I

i (Automated MGIT)

i i II _____---L _ l _~I

I AFB~Co-uCCltu-r-e- I Aerobic Culture- i Qualitative LJ Method [ I I I I i

I i i i

I AFB Staining ( Ziehl Neelsen Staining NA---shyI Light Microscopy i

I i

J-------shyI Aerobic Culture amp i Aerobic Culture I-Quiijitative I ABST i Biochemical Identification I

i amp ABST By i I i Disc Diffusion Method 1AeroblcCultureamp------TAero-bicCulture - --T Qualitative I ABST Automated Fluorescent i Detection Biochemical i i i Identification amp i i I ABST iL LtEl~()I1__Dilution-Ml9 1_

Dr Vandana Jain Devaki Devi Mandava Program Director Convenor


rtABL






isl--TPro-liuctT--------TSpecifcTest------- i Test Method )Range oftesling--iCVo~-i

i6J~~~EY~-~~~~~iureamp --I Aerobic Culture t~~il~~~tctiO-JNA=== Swab Throat I ABST i Biochemical Identification i Swab Nasal I ampABST by Disc Diffusion 1

Swab VaginalI I Method 1

Swab Urethral i Automated Biochemical i1

Swab Sputum i Identification ABST Broth Pus ET I dilution MIC

Secretion 1 iTracheal Secretion i i Body Fluids I

i Tissue Stool

i

i

l__~~_=~~ J j j-n ----J--------J-_ _- -_ bullbull _ bullbull__ bull bullbullbull_shy

7 i Body Fluids i Grams Staining I Grams Staining amp NA NA i Tissue i 1 Lig ht Microscopy i

Sputum Pus I ET Secretion

Ii i

I

Tracheal i i Secretion I Endocervical i i

Secretion Urine iI Prepared Slides I i Vaginal Smear i Urethral Smear

Eye Swab Ear ISwab Nasal Swab Throat Swab Vaginal i Swab Urethral i

____S~aJ j bull _

i 8 i Pus Sputum Identification of Fungal i KOH PreparatiOn-amp--------TNA- NA-----

i

I Skin i i I Scrapings I

Body Fluids Elements I Light Microscopy I 1

i Nails Hair 1

E S b _ Li __ bull_____- 1__LY~~____ -- --- _ __

detAOAC 9-er7 Dr Vandana Jain

Convenor Program Director DevakiDeviMandava


IIflBL QCI






-Si-Tproduct------lspecific Test--- Test Method --------------TRangeO(Testin9i Tcv-i i ~rial of i Performed _ 1 iLimits of Detecti~nL j

-- nar Swab -- -T-- -- T------------------------- ------- i

I~~~~J L____9 i Serum i Anti Cyclic Citrullinated i ELISA i POsitiveNegative----i8~9-- i

I~i=~ -middoti~~~amp~~~~=j~~~~~j i 12 i Serum Anti ds-DNAAntibody i IFA i PositiveNegative I NA i i-- i _11FA (Q~alitatl~ -i i -- - - - - middot -- -1---------1 I 13 i Serum I Anti Mitochondrial i ELISA i PositiveNegative I 22 iiiiAntibodv iii _--~ j ----------------------------------------------_bull ------- __-_ ------__---_bull 14 i Serum i Anti Neutrophilic IFA i PositiveNegative i NA i I i Cytoplasmic iii i

J----------------J~g~~l~~-~~~~------------L--------------------------------1- - ------J-- ------Ii 15 I Serum i Anti Neutrophilic i IFA i PositiveNegative NA Cytoplasmic i i t i L~1~~QcJy-__I1er~ L 1_____ __ __ _ _ _L __i [1sect i Serlrr JAn~c1eAni9QcJ_Jr~Isect~ Jpoundo_~tiveIII_e9tive JJ i 17 i Serum I Anti Nuclear Antibody - i IFA PositiveNegative i NA 1_J LIf~__(gJ_a_~_t~t~v(02 _L L(Pttlrn_ld(Ontiic_ati()l1l__ _____ 18 i Serum i Anti NuclearAntibody- i IFA i 140 to 12560 iNA i I Titres i i i ---------1--------------------------------------------------------------- - - - - - --------- i 19 Serum Anti Phospholipid IgG ELISA PositiveNegative 42 i i Antibodv ----------+------------------------t------------I-------- ~ +-------~-----------------~~-- --- ~ - - - - -- - --------1--------------- ji 20 i Serum Anti Phospholipid IgM i ELISA i PositiveNegative i 93 iI

i i Antibody iii i [21 lsecteum J~~ntrSm Antib9~=====r(LIsect_ ____==_==rFosiiie~eg_aii~middot T~lt5=_i 22 i Serum i Anti Smooth Muscle IFA 120 to 1320 NA i i_L J~l~QQLIt~e_s_~ _ _ __ L 23 i Serum i Anti Smooth Muscle i IFA i PositiveNegative NA i [__1____ I Antibod~JQu~lita~i~El) __L ~ __ j _ __L__ i

~C)~middot DevakiDeviMandava Dr Vandana Jain


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rtflBL SCOPE OF ACCREDITATION





i 51 i ~~~~i~~ ~f r-~~~~~~~esi---------------i TestMethod-----~l-~i~i~ ~b~~~~~-- cvoi~- I

_ _ ~st _ I ----==o==-=-_c=o=~----o=o==-==-===---J-==cc------ __ -_c-__c=cJ==oc_cccc= ~ ~~~~ ----+~~~~~~-f9~~~ii~~~y-i ~~j~~ ---------ibif~~g~~---+~---i [2~6~+~~~m -=--- TC~ANCAampR3) ==J_~oSA =~~~~-~=j-posill~elriE~~ij~e=_II~_=i i 27 i Serum i Cardiolipin IgA ELISA i PositiveNegative 79 i I I Antibody 1 i ii 28 i Serum i CardioliPi--jgC-----------T1--ELlSA----------middot-- r PoSitiveNegative middotmiddotmiddotmiddot-r2~3------i I Antibodl I I i r -----+----~------------------+--------------~-----~~----------------- --_--------- --middot--~middot_-middotmiddot-middot-middot_-middotmiddot-----l-----middotmiddot--middot-------j

i 29 i Serum i Cardiolipin IgM i ELISA i PositiveNegative i 43 i __ i ------- l _ Iii _ _ __ bull _ i Antibodl~_ 1

30 ~

i Serum i Cysticercosis IgG ELISA PositiveNegative i 13 ----r i I I Antibod I 1 I I r 3-1--tseum~m-----m---jcyiOme~aTovirlis-lgG---- i ELlSA----------~-i-posiiiveiNegative --j9~1----

i L ~_l--~ibl-dL-----------L- L _ 1 i 32 i Serum I Cytomegalovirus IgM i ELISA i PositiveNegative 61- I I l

1 I i AntibodY - -i_m__ -~---J-- jTQ~~~ 1_13 Serum i De~_g_~~9Q-~_~ocJYmi-l=l~-----m--m------------------m--L ~()itileiNeg9tilEl__ - i 3l_~erul1 m LPe~9 U~J9IY1JI_tibocJY J--~ LI S~_ _ ipoundoitiveNegsectiiEJ__UJ____i i 35 i Serum i Dengue NS1 Ag- ELISA PositiveNegative i 75 i i ELISA I i II---+------------J-= - ---lt-----------+------------------ - --+~ - ----middotmiddotI 36 i Serum I Echinococcus ELISA I PositiveNegative 70 i

37 Serum ----+~~~g~~~~f~~-tiCa--IELjSA--~----------------------lposiiiveNegative 6--0-- j-- I

I U~~~~~~~fsL----L----~--- --I-t-- --j3~~ru-----------------ple~laquo()-~-~er--ly~oUgc-i--~o1 S2_________fpoundoSitiveNegative Lct_ i i 39 i Serum I Hepatitis A virus IgM I ELISA I PositiveNegative 98 i ___ i -----llAV- 19ML_______ L i __ i--~---1 40 i Serum ~epatitis A virus-lgG 1 Competitive ELISA i PositiveNegative i 88 iI

_l ~_Jil_Y_g_Ql L ~ J__ ____ - -__ _J

l 41 i Serum i__nti3e m LCompet~ive ELI ~A LF()sJtive[Jegtiie___ 1 00__1 l~2t_~~~_ ~_~i JI BeAL L~o~~ ~ lxositilel[Jegltltife L10L]i 43 I Serum Hepatitis B surface i ELISA i PositiveNegative 123 1 L ~__ l_~I_ti~CJcJyJf_n_tifII3L_L j __L__ j

9twuO dergt Dr Vandana Jain

Convenor Program Director Devaki Devi Mandava


rtABL






lmiddotsT I ~r~~~j~~ ~f T~~~~eTdest i Test Method ---------T~i~~~i~~~~-~~middotIcvo--l

c===i=~T=est===_== - _ _ I i __ __ __L_______I --44 fSerum -THepatitis B Surface - i ELISA l PosjtileNegaiile-T3~2---i 45 i serum------1 ~~ia~~i~~B~~~------------t--EL1sA ---middot--i-posiiileNeg-ative----14~O----i 1m i i (HeV A~t_q~y)__ _ ~ -------------l---- n_J 46 Serum i Hepatitis Core ELISA PositiveNegative 32 i_l- L~__g_9_~ J_____ _______________L_ __L__ 1 47 Serum Hepatitis Core Competitive ELISA PositiveNegative 98 ---molI I

I

Antibody Total iii i4l_isect~u JJHHe~~~~~--~~f~-s--ig--G-i E~s- ~==b~()~iiileirgeg~tiJe=_==I~~=Q-=-=-- ~ ~~~~ I~~~~i~~~~~~0~~~ I-~t~~middot------------I-~~~~~~~~-~1~~-------1 ~------- 1 amp 2 inG ---+-- ---l------=--------tEc-- - ------l------ --------------------+----- --- __ oj

S1 I se~um ~el~mPleX viru~_J-~L1S~------------------_IPosltlveNeg~~~-__I__~~ __I

I 52 Serum Herpes Simplex Virus I ELISA i PositiveNegative i 142 I I

I L 11nG n ____ bullbullbullbullbullbullbullbullbullbullbullbullbullbull _L ____J1---- ______________ L_______

i 53 I Serum i Herpes Simplex Virus i ELISA i PositiveNegative i 99 i i _ I 11M l bull i1_ __9 ----- - --- ---------------

i 54 I Serum Herpes Simplex Virus i ELISA i PositiveNegative j 133 i i ~

I f---121gG-------------+-------------------------J ---- _ --------------- i i-----+ -middot---~ middot middot middot middot_1

55 Serum I Herpes Simplex Virus ELISA i PositiveNegative i 56 121 M I I i --------- ---9----------------------------+----------------------------------------------------~------~ I 56 Serum HIV 1 amp 2 Antibody I ELISA PositiveNegative 100 i J Iii I------+- I - ---~---------j------------------i------- ---- - --middotmiddot-------------middot( middot--------i 57 I Serum i HIV 1 amp 2 Antibody immunochromatography ReactiveNon Reactive I NA I

I Rapid i I ____1_____ j9hrQ~atQ_gI9PbL l i _ l_____

58 Serum HIV 1 amp 2 Antibody Immunofiltration ReactiveNon Reactive NA I i i Rapid

I i

I I --WImmunQfiltrsectlirL L L bullbullbull__j n ---lmm

i ~-----i Serum __UilY_1_)lYestElrrE3JelL_---JJ3Ilt2lin_L__________________ iPQsitiVElNegtiye____J 1J6__1 I 60 I Serum I Leptospira IgG i ELISA I PositiveNegative 68 _1 Antibodl J___ 1___L 1

~(~ Dr Vandana Jain






Certificate Number MC-2197 (inlieuofM-0541) Page 14 of 16


isT~TprOductT-------rs-pecifTc-lest----------TTestMethod [Range otTesingi i CV Material of i Performed 1 Limits of Detection i I T_e~t _ l L __ ~ j[6-1 1Serum i Leptospfra-rgM---------TEIIsA-------------------------T PositiveNegative ---176--j --J----------------L Antigt~QI L---------------f---- ------- --- -----l----------i [62 Serum ~easles IgQ~ntib()~LlE~IS-I I-F()~itieI Negsecttiye _~ i

i~~~ i ~~~ ------t~~b~Ktvt~f~-h--------l ~_E~~ ------------I-~~~t~~)~~~~~--i~-- i -KntibOdl i iS5 Serum------ I ~ubellavTruSi9M--j-EijSA -------------------- [PositiveNegative -_-middot_-i----9----2--------middotmiddotmiddot--middot-li----t ~nti~o~L L l _ __ __ i 66 Serum Toxoplasma gondii IgG i ELISA i PositiveNegative i 102 iI--1--------1 Anl~odl L - __ - _ 1

1

67 i Serum i Toxoplasma gondii i ELISA i PositiveNegative i 98 i laM Antibodl ----t i----------~------- -- ----- -- - - ------------------ 68 Serum Treponema Pallidum i Haemagglutination i ReactiveNon Reactive NA [i Haemagglutination iii 69+SerUm-------------j-~~~i~~lIaZoster-Virus---i-EITSA---------------- iPDsitiveNegative - --j 31 I G __ _~ J _L __ _ -_____ i70 i Serum I VDRL (BPRIestL__Elo~culsecttio~ IF3(la~~veINgn Rlt3ctiv~LJl~ bullJ 71 Serum Weil- Felix Test i Slide Agglutination i 180 and above i NA iI I

l L -l- ~___JignifiClt3nt_ _L 1 i 72 Serum Widal Test (Slide Test) Slide Agglutination 180 and above i NA i i---h----------l-----------------------------L----------------------

I

~ig_~fi~sectn_t ____ L__ oj 73 Serum Widal Test (Tube Test) Tube Agglutination i 180 and above i NA i i iii i significant i 1-741 WB-EDTA r~~~~~~i~e~r~~~~------P~yP(r~----------------[t~~-1o~~Pi~7~L 19-9---1 i i Load i LOD38IUmL i i 1 75 IWS-EDTA------T~~~~~~S~~~~~--TRl-PC-R--------j~~ middot~middot~~8~~toT5X---middot--1 iiiLoad i i LOD336IUmL[-7-el WB - EDTAi -I Herpes-Sim-plex Vir-us--TRlpc-R--------------joelectedNot - middot--NAmiddot -j i i CSF i DNA PCR - Qualitative i i Detected i

__1 L___________________1__ _ LL()D50C()pisjllL _ __1

9ala(C~ DevakiDeviMandava Dr Vandana Jain



HABL SCOPE OF ACCREDITATION

QCI



Certificate Number

Validity

MC-2197 (in lieu ofM-0541)

09072017 to 08072019

Page 15 of 16

Last Amended on

~C~ DevakiDeviMandava

Convenor Dr Vandana Jain Program Director

middot

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---------


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sITProductT----i-Specificlest--------- i TestMethoj------- -rRangeofTesiing t CV i Material of i Performed i i Lim its of Detection

__ l_~~ _1 L _ GENETICS

---------------------------------------------------r------- ---- ------------------------------ -----1 i WB-EDTA i HLA-Class I amp II DNA I Sequence Specific i Antigens Detected for i NA

_l LIYQirfL- A B DR LEIobes (sectsectEL i_flLf-AJ3ampjJ~ __L__ J 2 i WB-EDTA i HLA-Class I DNA Sequence Specific i Antigens Detected for NA i ___ i LIY2l1lil~c_C -----i Prbe~USSPL________i_IILA_ABIl~ i

3 WB-EDTA I HLA-Class II Alleles Sequence Specific I Antigens Detected i NA I

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6 l WB-EDTA JAK2 (Janus Kinase2) i RT-PCR i Detectedi NA I V617F for MPDs i i Not Detected I

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scr~r~~~i~~~f T~~~~~~eTdest-- ----rest Method -~------- r~i~~i6f~~~0~--CVOlo- j

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[ 16-1 Serum-------~---i CA125---------------i-CUA--------------------- -nt0500 UmC--102- ---I [17-Ts-erum-----i cAi53---------------i--c[TA-------------------1i- to 300 Um Lr90--

t1li~ru~---~E~~--==-------t~-[I~---=--==-=~==--==i~0_i06~UjrT1C-ll~~j 19 i Serum Calcium i O-cresolphthalein [ 5 to 15 mgdL 80 ii

[ i complexon (OCPC) ___ L __~ L ~_______ - - bullbull -------------------~------- -- - ------- J------- ----1 20 i Urine i Calcium i O-cresolphthalein i 5 to 15 mgdL i 90

i--j--------------L--~-----------j complexon (OCPltL_____L ----- -- -- i-- --Ii 21 i Serum I Carcino Embryonic I CLiA i 015 to 550 ngmL [ 115 i i IAntigen (CEA) i i t 2i-t~~um-= _4_lt~_~~2la~~In----i~-I11~~O-u-rii-=metry~=-=1~sect3to_1-~-gf- j_2~E i 23 i Serum Chloride i ISE DIRECT i 50 to 140 mmolL i 90 [2~ I~ine --==-L~~~~~ltf~===___=_l1JE~~~cX---==~-=Tlot~~5~mmoilL~~~~Ji 25 1 Serum Cholesterol - HDL i Direct Homogenous 0310 150 mgdL i 90 i i~_L~~~um ----1 ChOlesteroT__~~~~~=-=rcarcUi8ted-------~=rmiddotNAmiddotmiddotmiddot - --~- (NA---i

i~7middot_i SllIum _~_~ Ch~~~~~~_~~~_ __L~H0PAP j50~5001Tl9ldL middotmiddotmiddot-r-o-~ 28 i Serum I Cholesterol VLDL Calculated iNA i NA i [i9-TSerum --------iComplem-ent3(C3j-Ttmm-umiddotnoturbid-imetry----1064105oglmiddotmiddot middotmiddotmiddotmiddotmiddot-T9middot0---1 f middotmiddotmiddot-------+-------------------t~----------------middot +--------------------------~-------1-middot-----------_middot-middot --__-_ -- _- -1---------middotmiddotmiddotmiddotmiddot middotmiddot-i

l 30__ ~~~r~-r--------__l Complement 4 (C4L -rnrn_~_r~_u_~~~~rn~tI i_~tJ2 to 10gL )-100_31 [ Serum [ Cortisol I CLiA [ 020-75 ~gdL [ 120 i -1-____ -+_~__~ ~ ________1 ~ 1 middotmiddot __ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddot middotmiddot_ _ - ---__- ----1

i 32 Serum i C-Peptide i CLiA i 005-30 ngmL [ 100 i

I33-Tserum T~~~~ctivemiddotprote-in---Tlmmunolurbidimetry---116 to 250 mgj[_J-~~_J

i3~_ __ l~~~r _==middot-C~~~~nJ~~~==~~=]=J affEl-Kinetic--~~====-~=IOi~=~(jrrgj~L l-~s--i i 35 Urine Creatinine i Jaffe Kinetic i 5 to 400 mgdL i 90 i l I -i-----------------------J---------------------------------- ------ _ - _ _ - --j--------- ------j

i 36 i Serum I Dehydroepian- i CLiA i 15 to 1000 ~gdL [ 12 0 I drosterone Sulphate i imiddot

i i (DHEA-S) i3i~-iserum-------------t-Estrad ioneE-iT middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddot-~Ic CIA-===_-~_~~_Li1~tO~~~OEgirTIL middotT12~Omiddot-j i3s-rserum-----1 EstrioilJrlconfugated i CLiA l 007 to 12 ngmL -1-io -- j ~ Ll_~~2_______ _ __ l __~_ l ___ J

~o~middot Devaki Devi Mandava Dr Vandana Jain


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