Channo, a 20-year-old thalassaemic patient from Ghaziabad, a satellite town of New Delhi, considers herself unlucky. She contracted HIV (human immunodeficiency virus) from a blood transfusion some years ago. But that is not uncommon in India—six among 100 thalassaemics here run the risk of contracting HIV every year. What makes Channo’s—she preferred her pet name being used for this story—family feel cursed is that her brother, also a thalassaemic, died in 1999, succumbing to HIV that he also contracted through a blood transfusion.
Shortage of donated blood, a fragmented blood bank industry, lack of trained personnel and outmoded screening tests to keep out infected blood all heighten the risk of patients contracting HIV, Hepatitis B and C, and other infections every year. Not just thalassaemics and haemophiliacs, others requiring blood transfusions at surgeries, after accidents or during childbirth are also at risk. (Thalassaemia and haemophilia are genetic disorders relating to haemoglobin production and slow clotting of blood, respectively.)
India requires 8.5-10 million units (one unit is about half a litre) of blood every year and the supply, at 6.5-8 million, is short by a good margin.
Findings of a 2005 multi-centre study said one sample in 1,528 escaped detection by tests currently used to scan for HIV, and Hepatitis B and C. Given that one sample can infect up to four people as blood is broken into different components—plasma, red blood cells concentrate, platelets and cryoprecipitate—the risk of infection goes up as many times.
Conducted by Dr R.N. Makroo, director (department of transfusion ?medicine), New Delhi’s Indraprastha Apollo Hospital, the study sampled 12,224 blood specimens from eight blood centres across seven cities. The one sample that was detected was done using a superior testing technology called nucleic acid test, or NAT, and had slipped past the older, conventional tests used in most of India’s more than 2,200 blood banks that flag infections by detecting antibodies generated by the human body to combat a virus.
Current tests use techniques such as the ELISA, or enzyme-linked immunosorbent assay, test for the presence of antibodies reacting to HIV to detect an infection. The catch here is a “window period” of infection risk during which a donor’s blood may be carrying the viruses, but hasn’t yet star-ted producing the antibodies that can be spotted on the ELISA scanner. If donated during this period, the infected blood dodges the current tests and transmits the infection to the patient getting the transfusion.
A lab technician carries out a blood test at the Lions Blood Bank in New Delhi’s Shalimar Bagh. The blood bank uses chemiluminescence technology, which, its director says, can be a possible middle path between the current ELISA technique and the superior, but more expensive NAT technology.
Dr Makroo estimates the window period between four weeks and five weeks for HIV and Hepatitis B, and nearly three months for the Hepatitis C virus.
NAT, on the other hand, is a more sensitive test that detects the RNA/DNA (ribonucleic/ deoxyribonucleic acid) of the virus in blood after just a few days. It does not wait for the formation of antibodies, thereby reducing the window period risk for all the three viruses. NAT testing equipment is made by only two firms: Chiron, a unit of Novartis AG, and Hoffmann-La Roche Inc.
Rama Bhasin, who heads the blood bank in cardiology and neurosciences centre at All India Institute of Medical Sciences (AIIMS) in New Delhi, says: “We use the best ELISA kits, but they are not 100% sensitive. NAT testing has come in and there are suggestions to adopt it.”
It doesn’t help that the HIV, Hepatitis B and C populations are huge in India. The country is home to between two million and 3.1 million people living with HIV/AIDS, according to recent government estimates, with another 15 million infected with Hepatitis C and 43 million with Hepatitis B.
According to Dr Makroo, the incidence of these viruses in blood donors varies across different states, but ranges between 0.1% and 0.9% for HIV (or up to nine in 1,000 donors have the HIV virus), up to 2% for Hepatitis B, and 0.53% for Hepatitis C.
The global average of infected blood in banks is much lower. In the US, for instance, the frequency of viral transmission per unit of blood transfused is one in 1.5 million for HIV, one in 200,000 for Hepatitis B and one in a million for Hepatitis C. Given that mapping of such infected donors is patchy in India, the incidence of those infected among regular blood transfusions is high. A study completed this August on 550 thalassemic patients by National Thalassaemia Welfare Society, according to its general secretary J.S. Arora, found that 6% of such patients contracted HIV, 7.5% Hepatitis B and 16% Hepatitis C.
“Our children are not 100% safe. They are still at risk (despite stricter testing norms since 2000),” says Shobha Tuli, secretary, Thalassemics India, a patient group.
Families of patients, doctors and even some government officials echoed this view, but said they were helpless since alternatives are expensive. “Who do you fight with (over) unsafe blood? Are you going to fight with those people who are giving it to you for free, knowing that your child can’t live without it? If we protest, we may be simply turned out. So, we learn to accept the possibility of risk,” says Rashmi Kalra, mother of a seven-year-old thalassaemic son.
Experts bemoan the fact that there isn’t a culture in India to donate blood on a regular basis. “Safe blood starts with safe donors,” says Dr Makroo, adding that blood from voluntary donors is likely to be much safer than that received from repeat donors, who do so indiscriminately for money.
Agrees S.P. Agarwal, the secretary general of Indian Red Cross Society, which controls one-tenth of the country’s blood supply. “The only solution is an army of voluntary, unremunerated and regular blood donors,” he says.
While experts agree that the NAT technology reduces substantially the possibility of infected blood in blood banks, it comes at a steep price. NAT testing requires an initial investment of equipment worth Rs40 lakh and can increase the cost of a unit of blood by Rs1,000—blood is available either free for patient groups such as thalassaemics or less than Rs500 in government hospitals, today—for a mid-sized blood bank. If sample-volume increases from, say, 10,000 to a million, this cost could halve.
Given that blood banks are small and many, one way out could be centralized large-scale NAT testing laboratories. “With NAT, we can reduce the incidence of such infection by 50-60%,” says Arora of National Thalassaemia Welfare Society. More than 30 nations use NAT kits—widely in some instances such as South Africa and only for patients in Thailand willing to pay extra for blood that is tested such—says Chiron’s chief medical officer Andrew Heaton.
In India, hospitals such as Indraprastha Apollo have shifted to NAT testing and charge Rs2,000 a unit of blood to cover the cost of blood bags and tests. Half a dozen Mumbai hospitals and the Rotary-TTK blood bank in Bangalore, too, have shifted. AIIMS is planning to introduce NAT testing and Indian Red Cross Society is undertaking a massive modernization drive that will include NAT introduction over time.
But the high cost of NAT makes it a luxury for government and trust-owned hospitals that run on tight budgets. The National AIDS Control Organization, or NACO, part of the Union ministry of health and family welfare, suggests a price of Rs500 per unit of blood and other government rules mandate thalassaemics receive it for free. As of now, NAT is an optional test and has not been specified as a mandatory add-on test after ELISA by the Drugs Controller General of India.
Some patients say the price hike ought to be borne by the government. “Families with thalassemic kids anyway spend Rs6,000-20,000 per month in medicines and hospital facilities. At least they should receive blood free of cost no matter what. Charge an accident case or other such one-time transfusion case,” says Tuli who represents these patients.
The costs of introducing NAT across the country could run between Rs500 crore and Rs1,000 crore depending on how centrally NAT testing is done. The question is who will foot the bill, says a senior official of National Blood Transfusion Council, a policy body with the health ministry. “Making NAT compulsory should be considered, but there is a problem of cost,” says Kavita Chatterjee, a member of the council, which is considering asking the Drugs Controller to use NAT.
Drugs controller M. Venkateswarlu says he is guided by the council’s recommendations and “will look into this if they suggest making NAT mandatory”. But, he adds, suggestions that the government pay for it alone may not be practical.
Another technology that is midway in terms of efficacy between NAT and ELISA tests, is called chemiluminescence. Offered by Johnson & Johnson, it comes at a cost of Rs30 lakh and increases the per unit cost of blood by Rs200. It reduces the window period for HIV to 17 days—NAT reduces it to six —and, according to N.K. Bhatia, medical director in New Delhi-based Lions Blood Bank, misses one infected sample in 423,000 that can be caught by the superior NAT.
“I’m not denying that NAT is better, but India is not NAT-ready right now. Chemiluminescence can be a possible middle path, a negotiable solution,” says Bhatia, who estimates that about 100 Indian blood banks, including his own, use this technology. A crucial aspect for both these technologies, however, will be centralizing testing facilities so that the per unit testing cost is reduced.
Some government initiatives are on the anvil and could go some distance in easing the problems of blood availability, access and quality. While announcing the third phase of the National AIDS Control Programme in July, health minister Anbumani Ramadoss had announced a blood transfusion authority on the lines of the US food and drug administration to look into issues related to blood collection, storage, distribution and supply. He had also announced setting up of four centres of excellence with a capacity to collect and process 100,000 units of blood annually.
“I am confident that in the next couple of years, we will be able to have a world class system of blood collection and distribution,” Ramadoss predicted. “This will help in bringing down blood transmissible diseases such as HIV, Hepatitis B, etc.”
He didn’t say how the government would do so.