Times of India
17 December 2008
By Umesh Isalkar
Pune, India

Despite who’s updated reference range, most labs in the city are using the old criteria for sperm count analysis
A 33–year–old sales executive was depressed as his semen analysis report had indicated that he was having a low sperm count. After months of brooding and sulking, he approached an infertility expert for a second opinion and realised that his sperm count was actually normal. It turned out that the first diagnostic centre he approached was using an old criteria for semen analysis.

If you have been diagnosed with a low sperm count, then it’s time to go for a second test. As despite the updated reference range, which was released by the World Health Organisation in 1999, a large number of laboratories in the city are still using the old criteria during analysis. Thus a normal count gets falsely reported as ‘Low’, say experts.

“The WHO in its Semen Analysis Laboratory Manual has set the normal sperm count range at 20 million/ml. But 50 per cent of the laboratories even today continue to stick to the old norm of 40 million/ml, which is absolutely wrong,” infertility expert Sanjeev Khurd told TOI.

Highlighting the importance of semen analysis, Khurd said that it gives important information on sperm count, motility and morphology. A normal fluctuation in the count and motility is physiological and natural. But low count and motility are a great cause of worry for people planning to have a child, he said.

“The apparent simplicity of the test can be very misleading because in reality, it requires a lot of skill to perform the analysis accurately. It is very easy to do this test incorrectly (as it is often done by poorly–trained technicians in small laboratories) and the report can be very misleading, leading to confusion and angst for both the patient and his family,” andrologist Rupin Shah told TOI.

“The values reported in the semen analysis should only be a guide to understand where the person stands on the fertility scale. And as long as there are motile (moving with forward progression) sperms, whatever their number, he still has a chance to father a child naturally,” said Shah.

“Considering the lack of standardisation in semen analysis, the WHO had set a standard for these tests in 1980. Since then, it has revised the scale four times. The last updated was released in 1999,” said Shah. However, every pathologist follows his own method.

Pathologist Avanti Golwilkar Mehendale of the Golwilkar Metropolis, one of the two accredited pathological labs in the city, said that in order to avoid confusion, her lab has refrained from mentioning the normal sperm count in the semen analysis report.

“Being an accredited lab, we follow standard operating procedures (SOP) as validated by the NIBL. When a person’s sperm count is found to be on the lower side, another pathologist is asked to review the test before handing over the report to the concerned person,” said Mehendale. We consider a normal count to be 20 million per ml and above and at least 50 per cent of the sperm should be motile. However, there are men with sperm counts as low as 3–5 million who have fathered children, she added.

Pathologist K.B. Niphadkar, president of the Indian Association of Practising Pathologist (IAPP), said, “At present, there is no regulatory body for pathology labs. But the Clinical Establishment Act 2001, which is likely to be introduced by the Union government, will regulate the pathology labs in the state.”

A recent order by the Bombay high court had barred persons with diploma in medical laboratory technology (DMLT) and certificate in medical laboratory technology (CMLT) from running a pathology lab. “As per the directive, only an MD in pathology and those with diploma in clinical pathology (DCP) can run labs. But this directive has not been implemented in toto. The high court had also asked district collectors to prevent disqualified people from running such labs,” said Niphadkar. Those with DMLT and CMLT certificates can work as technicians in labs, but can not interpret test reports, he said.

“There is no uniformity about the guidelines among the pathologists. Everyone follows his own method of diagnosis,” added Niphadkar.

Testing Truths

• One only needs a licence under the Shop and Establishment Act to set up a diagnostic laboratory
• The need for standardisation and quality management in diagnostic labs was highlighted by the death of Union minister P.R. Kumaramanglam in 2000, allegedly due to misdiagnosis
• This prompted the Union health ministry to ask state governments to introduce regulatory and quality control mechanisms in the healthcare sector
• The state government responded with the Maharashtra Clinical Establishments Bill 2001 to regulate nursing homes, hospitals and pathology laboratories
• A draft of this legislation is awaiting approval of the law and judiciary department
• The Union government also assigned the National Accreditation Board For Testing and Calibration Laboratories (NABL) with the task of auditing diagnostic labs. But these audits are voluntary
• Pathologists and consumer organisations had opposed a 1998 regulatory proposal to control pathology laboratories.

Counting Mistake

• Normal sperm count as set by the WHO is 20 million/ml and above
• But the range followed by a large number of labs in the city is 40 million/ml to 120 million
• Most of these private labs use Neubars Chamber or Meckler Chambers to assess the semen count
• Ideally, these tests should be done at centres with computer assisted sperm analysis (CASA)
• But there are no labs in the city with CASA
• Moreover, there are only two accredited path labs in the city

What is low sperm count?
If a sample has less than 20 million sperm per ml, it is considered as low sperm count. Less than 10 million is very low and the technical term for this condition is oligospermia (oligo means few). Azoospermics are those with no sperms at all. This can come as a rude shock to these patients as their semen look absolutely normal, but it is only on microscopic examination that the problem is detected.

Is just one test enough?
If the sperm test is abnormal, atleast 3–4 tests over a period of 3–6 months are required to confirm whether the abnormality is persistent or not. So don’t jump into conclusions based on just one report. The sperm counts also do tend to vary on their own. It takes six weeks for the testes to produce a new sperm which is why you need to wait before repeating the test. It also makes sense to go to a different laboratory for the next test to ensure that the diagnosis is correct.

What leads to incorrect semen analysis?

• Incorrect collection technique
• Too much time between collecting the sample and testing
• A short interval since the previous ejaculation
• Illness in the last 3 months (even a flu or a fever can temporarily depress the count)