Pregnancy Test Pack Accuracy

Posted on Wednesday, January 26th, 2011 at 8:17 am

The Pregnancy Test


The Pregnancy Test


$3.95


Ordinarily, I’m a fan of pink–lovely color, does smashing things for the complexion. But not when it’s the bright, glaring stripe staring back at me on the pregnancy test. Then, pink is the color of major oops, of morning sickness, of boyfriends who seemed decent but now are part of some Jerk Witness Protection Program. Still, I’ve got a few things going for me–bitter humor, a divine right to eat till I’m the size of Marlon Brando, and good friends who’ve managed to get me a job interview with one Damien Sharpton: in need of a personal assistant, and some say, a good, swift kick in the arse. If you want to make a lasting impression, by all means, toss your cookies in your future boss’s wastebasket, which is located directly between his excruciatingly sexy legs. Apparently, Mr. Gorgeous-But-Unbearably-Anti-Social must like personal assistants who violate his trash can, because I got the job. And if I can avoid him via text messaging for the next seven months of health insurance, everything will be just fine. Except that he’s just asked–no, insisted–that I go with him on a business trip to the Caribbean. Gulp, Ordinarily, this would be cause for celebration. Ordinarily, I’d shave my legs, pack my bikini, revel in day-glo drinks and my seething lust for Mr. Swarthy-And-Secretive. But there’s nothing ordinary about this situation…which means it could be absolutely extraordinary.

Clearblue Easy Pregnancy Test - Twin Pack


Clearblue Easy Pregnancy Test – Twin Pack


$9.99


Pregnancy test with +/- results. Results 5 days sooner. Clearblue Easy can be used as early as 4 days before you expect your period. That’s 5 days sooner than waiting until you miss your period to test. The amount of pregnancy hormone increases rapidly in early pregnancy. In clinical testing with early pregnancy samples, Clearblue Easy gave the following results: 1 Day before the expected period 87% women giving a pregnant result. 2 Days before the expected period 84% women giving a pregnant result. 3 Days before the expected period 74% women giving a pregnant result. 4 Days before the expected period 53% women giving a pregnant result). + = pregnant. – = not pregnant. No test is more accurate. Over 99% accurate (99% accurate at detecting typical pregnancy hormone levels. Note that hormone levels vary. See insert) from the day of your expected period. Changes color to let you know it’s working. Made in China.

First Response Rapid Result Pregnancy Test - Twin Pack


First Response Rapid Result Pregnancy Test – Twin Pack


$8.29


Pregnancy test – rapid result. Rapid results in 1 minute. Over 99% accurate (99% accurate at detecting typical hormone levels. Note that hormone levels vary) from the day of your expected period. Pregnant? How long can you bear the question? There’s pregnancy test designed to tell you faster as soon as you miss your period. First Response Rapid Result Pregnancy Test is so sensitive it can tell you just 1 minute after you test. Now the most anxious questions you may ever face can be resolved as soon as possible. This kit contains 2 First Response Rapid Result Pregnancy Test sticks and instructions (in English and Spanish).

Pregnancy


Pregnancy


$10.46


Pregnancy

Canine Pregnancy Test Kit (5 tests)


Canine Pregnancy Test Kit (5 tests)


$125.95


Rapid immunomigration test for detection of the hormone relaxin in canine blood. Can be used at 22 days gestation or after. A small blood sample must be obtained from the dog. 5 tests in each kit. * Early detection of planned or unplanned pregnancy. * Detection of pregnancy before or after abortion treatment. * Early detection of false pregnancy. * Diagnose fetal resorption or spontaneous abortion. * No refrigeration required. About the product: The Witness Relaxin kit is intended to determine pregnancy in the bitch, as well as to distinguish between pseudopregancy and gestation. The kit measures relaxin levels in plasma and serum samples. The presence of significant amounts of this hormone is a reliable indicator of pregancy. Relaxin can be detected in biological samples soon after implantation of the fertilized egg, which occurs about 22-27 days after mating (26-31 days post-LH surge).

Clearblue Easy Digital Pregnancy Test - 2 Count


Clearblue Easy Digital Pregnancy Test – 2 Count


$9.69


The Clearblue Easy Digital Pregnancy Test is over 99% accurate at detecting typical pregnancy hormone levels (note that hormone levels vary – see insert) from the day of your expected period. Clearblue Easy can be used as early as 4 days before you expect your period. That’s 5 days sooner than waiting until you miss your period to test.This package includes 2 test sticks and 1 English/Spanish Insert.1. Take the test: simply hold the stick pointing downwards in your urine stream for 5 seconds only.2. Wait: an hour glass symbol will flash to show you the test is working.3. Read your result: within 3 minutes your result will be displayed in words.Read instructions before use. English and Spanish instructions inside.Store at 36&def;F-86°F. Do not freeze. For in-vitro diagnostic use only (not for internal use).

WITNESS RELAXIN [Canine / Feline Pregnancy Test]


WITNESS RELAXIN [Canine / Feline Pregnancy Test]


$132.22


Relaxin can be detected in biological samples soon after implantation of the fertilized egg, which occurs 20-31 days post-LH surge, or approximately 16-33 days post-mating. ? Early detection of planned or unplanned pregnancy ? Detection of pregnancy befor

pregnancy test pack accuracy


Clearblue Easy Digital Ovulation Test, 20 Count (Packaging May Vary)


Clearblue Easy Digital Ovulation Test, 20 Count (Packaging May Vary)


$23.82


CLEARBLUE EASY OVULAT DIG TEST Size: 20…

Wondfo Pregnancy Test Strips, 25-count


Wondfo Pregnancy Test Strips, 25-count


$3.09


HOW DOES IT WORK? Human chorionic gonadotropin (hCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone. HOW TO READ THE RESULTS Negative (not pregnant): Only one color band appears, in the Control Zone. No apparent band on the Test Zone. This indicates that no…

Combo pack 40 (LH) Ovulation tests and 10 (HCG) Pregnancy tests


Combo pack 40 (LH) Ovulation tests and 10 (HCG) Pregnancy tests


$11.43


The most simple and economical alternative for clinical diagnostic testing. The HCG pregnancy strip is designed for rapid determination of pregnancy conditions in urine specimens. The strip is dipped into a sample for 3-5 seconds. The reaction approximately takes 5 minutes with visual development of control and test lines. One Step LH Ovulation Test is fast and easy-to-use. It is a qualitative tes…

Ultra404 16 in 1 Video Game Pack

“On The Growth Path-Diagnostics And Pathological Testing Market In India”

“On the growth path-Diagnostics and Pathological Testing Market in India”

The Growing Indian Healthcare Industry

The healthcare industry in India is growing at a rapid pace and it is poised to become one of the dominant participants of the Indian economy. According to a Yes Bank and ASSOCHAM report, the Indian health care industry is estimated to grow at 23% p.a. to $77 billion by 2012 from the current $35 billion. The sector has grown at a rate of 9.3% from the year 2000 to 2009.

Of the sum, diagnostic and pathology services would account for $2.5 billion in 2012, more than double its estimated current size of $1billion. The growth in the segment is expected to be driven by consolidation in the industry and increasing insurance penetration among the country’s population. Healthcare facilities, inclusive of public and private hospitals, the core sector, around which the healthcare sector is centered, would continue to contribute over 70% of the total sector and touch a figure of $54.7 billion by 2012

According McKinsey report, the Indian healthcare market is expected to grow at a rate of 10-12 percent p.a. This is being driven by a strong local demand and growing population. With average household consumption expected to increase by more than 7 per cent per annum, the annual healthcare expenditure is projected to grow at 10 per cent and also the number of insured is likely to jump from 100 million to 220 million. India’s high population makes it an important player in this industry. According to the Insurance Regulatory and Development Authority, the Indian healthcare industry has the potential to show the same exponential growth that the software and pharmaceutical industries have shown in the past decade. Only 10 per cent of the market potential has been tapped till date. This is indicative of the strong growth potential of the Indian healthcare market.

The last few years have seen a rise in the purchasing power of the middle class. With an erratic and sedentary urban lifestyle of the growing middle and upper-middle class in India, healthcare has become an important component of everyone’s life. Expenditure on healthcare is rising with increase in self-awareness and availability of high-class healthcare facilities with the advent of private players. According to ICRA 2005 report on Indian Medical Care Industry, India spends 5.10 percent of its GDP on healthcare. India’s expenditure on health, in terms of percentage of GDP, is among the highest for developing countries. India is being seen as the preferred destination for quality health solutions due to the major cost advantage over the western countries.

The burgeoning segment; Pathology and Diagnostics testing market in India

 The diagnostics and pathology testing market in India represents one of the most lucrative markets in the world. The market has grown robustly in past few years on the back of increasing disease prevalence and rising consumer awareness. There are 2 major segments of the Diagnostics Market:

1) Pathological Laboratories             2) Diagnostic kits and reagents

Both of the above segments provide very strong potential for growth, both in the domestic market and as a preferred hub for clinical trials and outsourcing from western countries.

Pathological Laboratory Business

 The revenues from diagnostic segments are projected to grow at a CAGR of around 20% during 2010-2012. With increasing awareness among people about having a healthy lifestyle; the diagnostic market in India will experience strong growth in coming years. The country is witnessing a strong growth in biochemical and molecular diagnostic test segments.

The pathology market is currently 2.5 per cent of the overall healthcare delivery market. As per industry estimates, there are over 40,000 independent pathology labs in the country servicing around 1-1.25 million patients per day. This includes specialized laboratories, laboratory facilities in hospitals and nursing homes and small testing centers with basic facilities. The quality of services provided by these labs varies widely. The National Accreditation Board of Laboratories (NABL) has been established to accredit the laboratories, but the number of laboratories actually accredited is still minimal with majority of players operating in the vast unorganized segment.

Currently there are a few large national Players like Super Religare laboratories, Dr. Lal Pathlabs, Metropolis, Thyrocare, Max Health Care, and Apollo Clinics. Quest Diagnostics, a major international player has also entered India in the recent past. The industry is highly competitive and price-driven with kickbacks and business referral payments in the absence of a regulatory body. Around 70 per cent of treatment decisions in the country are based on lab results.

Major Indian Players in the Pathological Laboratory and Clinical Trials Segment

Super Religare Laboratories

Dr. Lal Pathlabs

Metropolis

Thyrocare

Vimta Labs

Quest Diagnostics

Diagnostic Kits and Equipment Segment

The diagnostic kits and reagents segment in India is a relatively new segment. Diagnostic kits consist of syringes, vacutainers, swabs etc. used at the time of sample collection whereas reagents are compounds, such as sulphuric acid, hydrochloric acid, sodium hydroxide, etc., used in the laboratory for chemical analysis or experiments.

 In addition to the presence of international players, at present India has more than 25 companies manufacturing diagnostic kits. These diagnostic companies are manufacturing and selling kits mainly in the areas of pregnancy, ovulation, estimation of T3, T4 & TSH, HIV, HBV and HCV infection, rheumatoid diseases and disorders, cancer (cervix, colon, prostate, lung, mouth etc.), kidney function and liver function.

There has been an increase in the utilization of diagnostic devices and tests in last few years. The major reason for this is the increase in consumer awareness, increasing income of middle class consumers and spurt in the health insurance schemes which is leading to increased usage of diagnostic kits. The number of tests conducted in the last decade has more than doubled from 180 million to over 500 million. There are over 11,500 hospitals and 14,000 diagnostic laboratories in the country that utilize large volumes of diagnostics. The major factor that is driving the growth of manufacturing of diagnostic kits in India is the 70-80 percent cost advantage that Indian laboratories offer over their western counterparts.

The Indian companies with their R&D facilities have developed a range of quality products which are giving a tough competition to imported kits. However, there are hi-tech products like Elisa, PCR, a few cancer markers and some other products for which there are very few manufacturers in the country. Though there have been major developments, still the diagnostic kits and reagents market has a long way to go.

Some of the companies manufacturing diagnostic kits include Accurex Biomedicals, Beacon Diagnostics, Bhat Biotech, Bio-systems Diagnostics J Mitra & Co, Monozyme India, Span Diagnostics Ltd, Transasia Biomedicals, Tulip Group and XCyton Diagnostics.

Trends in the Indian Pathological Laboratory Segment

Of late, Indian Pathological and diagnostics industry is witnessing some action with the entry of bigger players and international companies. Apart from the growth in the domestic segment, India has the potential of becoming an international hub for Clinical trials and export of reagents and diagnostic kits. The cost advantage that Indian companies have over their western counterparts could play a major differentiator. Following are some of the trends being witnessed in the Indian pathology segment:

Consolidation and Takeovers

Today there are 800 private labs in the US of which the top 10 laboratories carry out 85 percent of the pathological workload. Earlier like in India, the US too had standalone labs but the scenario changed when health insurance entered the US healthcare market. Insurance companies tied up with labs that had quality control, uniform systems of billing and services. This consolidation came about and the functioning changed. Since in India, the public healthcare system is falling apart and there is a growth of around 20 per cent in private sector each year. International health insurance companies entering India tie up with pathology chains, thereby changing the face of the diagnostic industry.

With the advent of large pathology laboratories chain, the Indian diagnostics landscape has undergone some major changes in the last four to five years. One of the significant impacts has been the rising competition among the large players, which may not have cut down the prices to the consumers, but has surely raised the entry barriers for small path labs, which mushroomed in the nineties to uncontrollable proportions. Now, large path labs say that consolidation is imminent and they quote the US example which evolved in a similar way, but is today dominated by only four major chains of path labs.

Though large path labs have been showing impressive growth rates (for instance Metropolis claims that its business grew 50 per cent over last year, while the overall market growth was estimated at 25 per cent), a large portion of the market is still dominated by the unorganized sector.

Large path labs have outperformed the industry growth estimates and it is obvious that they are eating into the share of small labs. For instance, a test for diabetes is generally done at small labs by arbitrary calculation in 80-90 per cent of the cases. Large labs claim that this method is unreliable, while direct estimation offer accurate results. As the consumer awareness is increasing, organized players with more focus on quality and accuracy are taking on smaller players head-on.

Major emphasis on Quality and Technology

With the advent of International players and large corporates, there has been a major focus on providing enhanced quality right from sample collection, sample transportation to actual testing of sample in the lab.

There has been a major improvement in sample collection procedures with the use of sealed sample collection kits and vacutainers. There has been major focus on training phlebotomists (technicians who draw blood); emphasis is on their technical as well as communication skills to enhance end-customer experience.

Another milestone has been the use of barcodes for sample tracking and transportation for proper delivery of the sample to the lab and avoiding sample misplacements. Lastly, temperature controlled gel packs and boxes are increasingly getting used to maintain sample integrity and maintaining correct reporting.

Focus towards wellness testing, in addition to normal disease testing

Wellness testing is a new concept and is meant for apparently healthy individuals who are not aware whether they are suffering from a particular disease. Among the organized players, there has been an increasing trend towards targeting healthy individuals who have sedentary lifestyles and are more risk prone for lifestyle diseases such as cardiovascular and diabetes ailments.

Organized players have developed specific panels such as full body screening panels, diabetes panel, cardiovascular panel, thyroid panel etc. to tap into this segment. A panel comprises of bouquet of tests for that specific disease or ailment. For example, a thyroid panel would consist of specific tests such as T3, T4 and TSH.  Therefore, these panels are product packages designed for end customers and are easy to understand and provide a comprehensive analysis as compared to individual tests. The whole notion behind this is to encourage consumers to self-initiate these tests rather than taking a doctor’s prescription which is generally required for advanced and complicated tests like cancer, osteoporosis and other ailments.

Thus, companies are trying to create an interest for the diagnostics category amongst the masses so that they can monitor their disease levels themselves and thus generating a lot of end-customer involvement.

Brand Building initiatives by Organized Players

Recently a lot of action is seen in advertisement space from major diagnostic players and hospitals. There has been a conscious effort by major players to differentiate their brands and services from competitors and the unorganized segment. From SRL, Fortis, Dr. Lal Pathlabs, Apollo Clinics, everyone is using advertising and focusing more towards brand development which was absent around 3-4 years back.

Companies are trying to create specific testing products in the form of health and disease panels which generally include a bouquet of tests for general health checkup or particular ailments. Thus, for promoting these products various Above the Line (ATL) and Below the Line (BTL) mediums are being used for the same. From outdoors to print, from radio to direct marketing, diagnostics and Pathlabs are present everywhere.

 

Issues in the Indian Diagnostic Kits and Reagents Industry:

The diagnostic kits and reagents segment provides a huge opportunity. But still there are various issues which act as impediments and a strong action from both the industry and government is required to facilitate the same. Some of the key characteristics are as follows:

Diagnostic kits and reagents still being primarily imported

Although there is a huge opportunity in the diagnostic kits and reagents manufacturing segment but still more than half of the kits are being imported. These kits are imported at a higher cost and are often ineffective as these are not designed for Indian climatic conditions. There is a huge opportunity in the manufacturing of substitutes for these imported kits and reagents as per the Indian requirements. But there are some impediments in the path, these are highlighted as follows: 

  1. High import duty for raw materials and custom clearance procedures,
  2. competition from the western companies who offer more sophisticated products,
  3. lack of knowledge and expertise among the Indian manufacturers,
  4. licensing and slow pace of approvals from statutory authorities,
  5. Absence of national laboratory network for evaluation and approval of new products are some of the factors slowing down the pace of indigenization.

Red-tapism, lack of strong will power to remain in the business of diagnostics, regulatory confusion and lesser margins are some of the issues confronting the growth of the segment. Moreover, as the segment is very small, it is difficult to drive the struggle. Importing raw materials at high cost is also a major issue facing the segment.

There is an urgent need to address these issues with the Government authorities.

Lack of market and technical know-how

There is a serious opportunity in the diagnostic kits and reagents business, but our entrepreneurs are missing on this lucrative sector. Though the opportunity is huge, there are some hurdles in the way. These are as follows:

  1. lack of knowledge about the range of products,
  2. absence of technical expertise for these medical kits and reagents,
  3. Complex nature of manufacturing process.

In India, there is still a gap between the industry and academia. The authorities need to work towards enhancing public-private partnership. This will result in proper utilization of public funds and technology transfer to private sector.

The Department of Biotechnology (DBT) has been facilitating the transfer of many technologies for diagnostic kits to the industry developed at the CSIR labs.

Government Licensing

There are no standard guidelines and procedures for issuing license for manufacturing diagnostic products. Also the approval for the ranges of products is missing for both products manufactured in India or imported products. These vary from state to state. There is also no special package and exemption in taxes from the government for establishing diagnostic manufacturing units. The number of cheaper and efficient technology transfers in the area of diagnostics is limited.

This industry is considered to be a part of the pharma segment but really does not belong there. The authorities themselves are not knowledgeable about the diagnostics industry. Current rate of customs duty is a major disincentive, which makes the manufacturing not cost effective. Also there is an absence of any trade organization of diagnostic kits and reagents manufacturers to take these important issues with the authorities. 

 

India has the potential of becoming the global hub for R&D, clinical trials and pathology services. The major reasons in support of this are the growing health awareness and quality consciousness in the increasing middle class, opening of the health insurance industry, advent of private players and consolidations in the diagnostics and pathology segments, huge cost advantage of the clinical trials segment, availability of trained medical professionals, increased test-prescriptions in the urban and rural areas and initiation of Public-private partnerships.

But some corrective measures are required on the industry and government front to address various issues like licensing, limited technical expertise and stiff competition from imported products.

 

Sources:

  1. IBEF Industry report on Healthcare sector;
  2. National Accreditation Board for Testing and Calibration Laboratories;
  3. Biospectrum India
  4. Indian Expres Healthcare management
  5. India PR wire

About the Author

Mr. Nikhil Bhatia has completed B.Com (Hons.) from Shri Ram College of Commerce, Delhi University and MBA from IMT, Ghaziabad with specialization in Marketing & Finance. He has over four years’ corporate experience in healthcare and banking sectors. He is currently working with a leading healthcare MNC in marketing domain. In addition, he has done Industry oriented marketing projects with Maruti Udyog Limited and Kellogg’s India. He has to his credit projects and prize winning case study on “Rediff Bol-Marketing of Rediff.com online messenger” presented at SJMSOM, IIT Bombay and IMT, Ghaziabad. He has received merit scholarships from the Institute of Company Secretaries of India and the French Embassy in India.    


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