False HIV positive report by Ranbaxy SRL, Bombay

[Guest guest]

[i reckon, Mr. Gurinder Singh should seek legal assistance to seek compensation

from the Ranbaxy for the criminal negligence and emotional anguish. Moderator]

Colleagues,

I came across a real and problematic situation where one laboratory reported

one person not only HIV positive but also viral load significant. The

exposure history did not fit well with the findings and patient got his

serum tested in one and another laboratory and finally referred to my

laboratory for final answer. We repeated several tests but he was found HIV

negative by all other labs as well as in my lab. The patient has now written

a strongly worded letter to Project Director of NACO. The copy of this

letter has also been sent to me and is reproduced below.

Dr. Sarman Singh, MD. MNAMS

Head, Division of Clinical Microbiology

Department of Laboratory Medicine

All India Institute of Medical Sciences

P.O. Box. 4938

Ansari Nagar, New Delhi-110 029

India.

ssingh56@...

*****************************************************************

August 12, 2002

To,

The Project Director,

National AIDS Control Organisation (NACO)

9th Floor, Chandralok Building,

Janpath, Connought Place

New Delhi-110001

Subject: False HIV positive report by Ranbaxy SRL, Bombay

Madam,

I, Gurinder Singh, resident of D-333, Ranjit Avenue, Amritsar,( Punjab), am

a married man of 32 years. Due to some accidental but protected exposure on

13th July 2002, I wanted to get my HIV test done and my blood sample was

collected at Amritsar by the local sample collection center of the Ranbaxy

SRL on 17th July 2002 (accession no. 0002BG029072) (client

code-C000000086).

The Ranbaxy SRL sent a positive ( anti-HIV antibody) report which was a

shocking news for me. I again got tested at Chandigarh Clinical Laboratory,

Chandigarh which reported me as HIV antibody as well as p24 antigen

negative. To reconfirm I again gave my blood sample to Ranbaxy SRL

collection center on 31st July 2002 for viral load. Again the socking news

came from Ranbaxy reporting my HIV load of 4508 copies /ul ((accession no.

0002BG041725).

During this period no one provided me any counselling neither pre- or post

test. I kept on running here and there and ultimately I was referred to All

India Institute of Medical Sciences, New Delhi where me and my friend Dr.

Inderpal Singh Grover were directed to contact Dr. Sarman Singh, Head of

Clinical Microbiology, Department of Laboratory Medicine. He provided us

extensive pre-test counselling and he collected and tested my blood sample

in his laboratory using various tests for p24 antigen , anti-HIV antibodies

in ELISA, Rapid tests and Western blot. He again wanted my fresh sample

which I have given today and even the fresh sample he has reported negative.

He has also provided me extensive post-test counselling, for which I am

extremely thankful to him.

Madam, in this regard I would like to mention that the 20 days had been

extremely painful and tense for my life. At several occasions I had feeling

to commit suicide had my fried Dr. Inderpal Grover not been with me

throughout this period I would have not been in this world any more.

Therefore my humble plea is that you may issue guidelines that no private

laboratory which is not collecting patients' sample directly and not

providing pre-and post test counselling should be banned immediately. They

should strictly not be allowed to use 2-3 step collection and sub-collection

centers everywhere.

I hope that you would give serious though to this request.

Sincerely yours,

Gurinder Singh

S/o Tajinder Singh

D-333, Ranjit Avenue

Amritsar (Pb)

Ph; 0183-501816

_____________________

[Guest guest]

Dear forum subscribers,

I suggest, Mr. Gurinder Singh should seek legal assistance for Mental harassment

from the Ranbaxy for negligence they have done. Regarding SPECIALTY RANBAXY &

similar Laboratories existing in India.we do come across errors in reporting.

few months back one of my patient was given report of HIV DNA PCR(Qualitative)

as level undetectable & not Negative. Ideally it should be negative Or

Positive.I strongly argued the way report was given,but it was in vain.

Dr.Rajesh Buddhadev MD

E-mail: <buddhadev@...>

__________________________________

[Guest guest]

Dear Dr. Sarman Singh,

Being a client that paid Ranbaxy for the HIV test, Mr. Gurinder Singh can

also take the matter to the State Consumer Protection Forum for 'Deficiency

of Services', uner the Consumers Protection Act.

Regards

Aditya Bondyopadhyay [Advocate]

E-mail: <adit@...>

_________________________

[Guest guest]

[it appears that, one of the core issue related to the false HIV positive report

by Ranbaxy is lack of clear NACO/GOI policy guidelines on HIV testing by the

private labs. Moderator]

Yes, the national HIV testing strategy needs to be followed by all the testing

centres (both private and government). There are hardly any private facilities

in the country practising pre and post test counselling. I understand, all

private facitlites may not be able to set up such facilites but they can

develop linkages with NGOs which provide such service.

I doubt, if the issue of confidentiality is also respected. The blood is drawn

with the person's name, sent to the the lab with name and report comes with the

name. The reports are also handed over to the collector (may be anybody

presenting with the receipt)like any other report. Along with is the question

of testing quality. How many labs in our country really have some kind of

external monitoriong system?

I am not surprised to read the story of Mr Gurider Singh. Such many stories are

bound to occur with the existing system.

Dr Ashok Kumar Agarwal, MBBS,MD

108, Rastraguru Avenue,

Nager Bazar, Kolkata -700028, India

E-mail: <drashok_1963@...>

_____________________________________

[Guest guest]

[The issue of " 3 month window perod " is to be taken into consideraton only when

the rapid/ELISA tests are being applied. Not, when PCR test is employed. So

Subha shankara's advise is not so applicable in this case: Moderator]

Hello,

Without going into the issue the discrepancy of the various reports and of

what legal redress Mr. Gurinder Singh can get, which others have addressed,

he should know that there is a 3 month " window period " after contracting

the virus, and the HIV antibody test can be accurate only after that period.

I am concerned that he may think he is HIV negative, which he well might

be, but he needs to get retested 3 months after July 13, the date he feels

he was at risk for HIV infection. Only then will he get a truly negative

report.

Sincerely,

Subha Sankaran

Email: <aids@...>

_________________

[Guest guest]

Sir,

There are some my known facts;

In USA, HIV confirmation (WB) is only done by Govt., where all lab has to send

their positive sample compulsory with patient name and his social security

number. So they are able to gather exact no. of patient in their country,

if duplicated then computer will tell them by SSNo.

Quality in MNC, their lab.staff is not specially qualified for such work, i.e.

specialized training in abroad etc. or higher slab of payment. SRL ranbaxy is a

loss making unit of Ranbaxy. Recently their back bone Specialty Lab of USA had

broke their partnership & withdrawn the name.

In our country, all diagnostic company get HIV antibody,easily to produce kits,

irrespective of their performance.

The issue of " 3 month window period " is to be taken into consideration only

when the rapid/ELISA tests are being applied. Not, when PCR test is employed. So

Subha shankara's advise is not so applicable in this case-is absolutely Right.

Give your comments.

Rajesh Buddhadev Dr.MD

Former President-Indian Association Of Dermatologists, Venerelogists &

leprologists: GSB (1999-2000)

3 B Shashi Tower, 2nd Floor

Adajan Patia, Rander Road

Surat-395009.Gujarat.India

Phone 0261-2685 685, 0261-2686 682

E-mail: buddhadev@..., buddhadev@...

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[Guest guest]

I am from Australia and in we have one infectious diseases

laboratory, well staffed and equipped and it does all the testing very

accurately. It must be difficult for the laboratories in India because in my

reading of the various opinions of the Singh case there appears to be a

variety of understandings of the process and purpose of testing.

Clearly a test to detect antibodies is the test for exposure and it can take

some days after a risk exposure for the patient's body to start producing

antibodies. So if I had unprotected sex today it might be a week before

antibodies start producing and if I have the test tomorrow it will be

valueless and not indicative of exposure.

This is not the same as the definition for undetectable.

My understanding is that after a person has sero converted that is they have

the virus in their body then other tests are conducted usually in

conjunction with ARV's to determine viral load control and undetectable does

not mean negative, it just means that viral replication as measured in

particles of blood is below a certain number, once it was below 400 copies

was undetectible but now sophisticated tests can determine copies down to

50. If you have such a test report it means you still have the virus and you

are still capable of passing it on but it is not doing as much damage to

your own immune system.

It appears to be crucial that people understand that the time each person

will start producing antibodies i.e. the window period can be different and

this is crucial to understanding of the doctor before ordering a test that

he or she takes a good clinical history first.

We have had to produce protocols for gay men who believe that they are both

negative and are considering having unprotected anal intercourse in a

monogamous committed relationship.

It is impossible to get the virus if both partners are negative. It is not

the act that produces HIV it is exposure only.

So we have the T T T T method in our counselling.

T means Talk to each other about the relationship in a deep and meaningful

way about the decision.

Then T again means TEST, both go together and have a HIV test at the same

time and the results are shared between the partners and the doctor.

Then 3MONTHS later again T, TEST again, both together and sharing results.

the fourth T is TRUST and it is the most important part.

The couple agrees that if for any reason a lapse occurs then they advise

each other and resume protection until the T T T T process is repeated.

One of the difficulties of being +ve is that people think their sex lives

are over and they are reluctant to test because so does everyone else around

them and jobs, family and status can be affected. This doesn't need to

happen. It doesn't happen in some parts of the world and it shouldn't happen

here.

I don't know anyone who has a positive test and then deliberately goes and

infects someone else. One of the problems here appears to be there are

untested vectors who are unwittingly passing the virus on. There is also a

certain amount of ostrich behaviour around sex here also. We need to

demystify HIV because it is such a fragile virus that there are ways of

behaving that give pleasure without risk and +ve people need to be seen and

heard and valued.

I have resisted the urge to enter into the testing debate until now because

I am not a pathologist. For 12 years however I have been working with other

peoples test results and the antibody test was the breakthrough and we must

not get it confused or test unwisely.

Geoff Heaviside

Brimbank Community Initiatives Inc

Sponsoring Sunshine Budget Advisory Service

5 Brisbane Street

P.O. Box 606 Sunshine 3020

. Australia.

Ph: 0418 328 278

Ph/Fax : (03) 9311 5052

or in India

Mr Geoff Heaviside

Flat #10 Kash Towers

93 South West Boag Road

T.Nagar, Chennai

INDIA 600017

Ph: (91 44) 4329580

Mobile : (91) 9840 097 178

E-mail: <gheaviside@...>

_________________________________________________________________