MEDICAL TEST KITS

All our medical products carry our registered trademarks TRUTH or True BioScience. All our diagnostic test kits are manufactured in US and Canada only. Our OEM manufacturing plants are medical ISO and GMP certified. Medical test kits are certified and endorsed either by United States Food and Drug Administration, Health Canada and marked.

True BioScience test kits are recognized for its high standard of quality and its reliability. Our products submission to Malaysia Institute of Medical Research yield immediate recognition with specific tests registering 100% accuracy.

Below are some common products with our brand name;

1. Tumor markers
2. Cardiac markers
3. Infectious diseases
4. Drug of Abuse
5. Fertility
6. Urinalysis reagents strips
7. Customized kits

Test format

a. Strip format

Colored coded strip format for different test categories	Result interpretation	How to use Video
	Negative Positive Invalid

b. Cassette format

Pipette provided to draw specimen into the cassette’s well	Result interpretation
	Negative Positive Invalid

c. Midstream format

Midstream is for direct application of specimen	Result interpretation
	Negative Positive Invalid

Format Description Category

Test formats illustrated above are categorized under ONE-STEP TEST KITS. True BioScience also supports MEMBRANE TEST KITS.

Membrane tests have a high level of sensitivity and specificity. These are preferred format for clinical laboratories and medical professionals.

Two types are available:

1. Membrane-EIA format  (Membrane Enzyme ImmunoAssay )

Plasma or Serum specimen is added to the test device followed by enzyme conjugate solution and substrate reagent are added sequentially. Test results are read visually with the presence/absence of test dots on the test membrane. It is highly sensitive and easy to use and requires no other instrument.

2. Membrane-CGA format (Membrane Colloidal Gold Assay)

Plasma or Serum specimen is added with colloidal gold conjugate solution to the test device in sequence. Test results are read visually with the presence/absence of test dots on the test membrane. It is highly sensitive and easy to use and requires no other instrument.

Colloidal gold conjugate solution is provided with the test device.

1. Tumor markers

1. One-Step AFP test (Alpha Fetoprotein)

This is a rapid and direct binding test for the detection of Alpha Fetoprotein in Serum. It is used as an aid in diagnosis of primary hepatocellular carcinomas, testicular teratocarcinomas and neural tube defects. The test is based on the principle of sandwich immunoassay. Monoclonal and polyclonal antibodies are employed to identify AFP specifically.

Concentration of AFP in the specimen can be determined using membrane-EIA format by comparing the colour intensities of the test and control dots.

2. One-Step PSA test (Prostate Specific Antigen)

This is a rapid and direct binding test for the detection of Prostate Specific Antigen in Serum. It is used as an aid in diagnosis of prostate cancer. The test is based on the principle of sandwich immunoassay. Monoclonal and polyclonal antibodies are employed to identify AFP specifically.

3. One-Step CEA test (Carcinoma Embryonic Antigen)
   

This is a rapid and direct binding test for the detection of Carcinoma Embryonic Antigen in Serum. It is used as an aid in diagnosis of colorectal, breast, lung and pancreas cancer. The test is based on the principle of sandwich immunoassay. Monoclonal and polyclonal antibodies are employed to identify CEA specifically.

4. One-Step FOB test (Faecal Occult Blood)

This is a rapid and direct binding test for the detection of human occult blood in feces. The assay is designed to detect lower levels of colorectal bleeding than other biochemical detection methods. The test is based on the principle ofimmunochromatographic sandwich method to selectively identify hemoglobin in test specimens. Accuracy of the test is not affected by interfering substances and dietary restriction is not necessary.

TUMOR MARKERS
Classification	One-Step AFP test	One-Step PSA test	One-Step CEA test	One-Step FOB test
Test format
Test medium	Serum / Plasma / Whole Blood			Faces specimen
Certifying bodies
Product insert	AFP test insert	PSA test insert	CEA test insert	FOB test insert
Enquiry	Click
* For more details on the certifying status, pleasecontact True BiosScience.

2. Cardiac markers

1. One Step Troponin I (cTnl) test

One step Troponin I (cTnI) whole blood rapid test device is a colloidal gold/antibody complex based immunoassay designed for the qualitative of cardiac cTnI in whole blood. The test device contains of a test strip of a porous material embedded with two key test reagents, a movable colloidal gold labeled antibody at the conjugate zone and an immovable antibody at the test zone.

Intensity of the test line and the speed of its appearance will expedite with an increased concentration of cTnI in the sample.

2. One Step Myoglobin test

One Step Cassette Style Myoglobin Test is a rapid aid for the determination of Myoglobin in human whole blood, serum or plasma. With a few drops of sample, this test can quickly provide a qualitative, visual result to indicate the elevation of Myoglobin within a matter of minutes. The elevated levels of Myoglobin are used as an aid in the diagnosis of myocardial infarction.

3. CK MB Cardiac test

The CK-MB test strip is a colloidal gold/antibody complex based immunoassay designed for qualitative determination of CK-MB in whole blood. Cardiac creatine kinase (CK) MB isozyme is a dimeric soluble protein in cardiac muscle with a molecular weight of 80 kilodaltons. Following myocardial damage, CK-MB is rapidly released into the bloodstream within 2 to 6 hours after acute myocardial infarction (AMI).

CARDIAC MARKERS KITS Classification One-Step Troponin I (cTnI) test One-Step Myoglobin test CK-MB Cardiac test Test format Test medium Serum / Plasma / Whole Blood Country of use* Product insert One-Step Troponin I test inert One-Step Myoglobin insert test insert CK-MB Cardiac test Enquiry Click * For more details on the country of use, please contact True BioScience. TOP

3. Infectious diseases test kits

1. One-Step Chlamydia test

This test is a simple, one-step immunochromatographic assay intended for professional use only in the rapid detection of Chlamydia trachomatis Antigen.

Chlamydia trachomatis is one of the most common sexually transmitted pathogens. It is a major cause of cervicitis, urethritis, endometritis, and pelvic inflammatory disease in women. Serious complications can result in salpingitis, infertility, and ectopic pregnancy.  If transmitted to infants during birth, Chlamydia can cause conjunctivitis and pneumonia.

2. One-Step Helicobacter pylori (H. pylori) test

This rapid test on serum or whole blood detects qualitative absence or presence of antibodies specific to Helicobacter pylori (H. pylori). H. pylori antigen – colloid gold conjugate and specimen moves along the membrane chromatographically to the test region and forms a visible line as the reactions of antigen-antibody-antigen gold particle take place.

3. Syphilis test
   
   This one step test is a rapid, direct binding test for the visual detection of anti-syphilis antibodies in whole blood, serum or plasma. It is used as an aid in the diagnosis of syphilis infection. Test results are read visually without any instrument. It is based on the principle of double antigen sandwich immunoassay for determination of syphilis antibodies in whole blood, serum or plasma. Purified recombinant syphilis antigens are employed to identify anti-Syphilis antibodies specifically. It is highly sensitive and only takes about 10 to 20 minutes.
4. Malaria test
   
   Malaria is an infectious, fatal parasitic disease transmitted by the bite of infected Anopheles mosquitoes. This test is an immunochromatographic (rapid) test for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA) specific to Plasmodium falciparum and Plasmodium vivax simultaneously in human serum, plasma or whole blood. The test device contains a membrane strip pre-coated with recombinant malaria P.f and with recombinant malaria P.v . The recombinant malaria P.f/P.v antigen, colloid gold conjugate and serum sample moves along the membrane chromatographically to the test regions and forms a visible line as the antigen-antibody-antigen gold particle complex forms with high degree of sensitivity and specificity
5. Dengue test
   
   Dengue rapid test is a qualitative test for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma and whole blood. The test provides a differential detection of anti-dengue IgM and anti-dengue-IgG antibodies and can be used for the presumptive distinction between a primary and secondary dengue infection. The immune response to this virus includes the production of IgM antibodies by the 5 th day of symptoms. IgG antibodies appears by the 14 th day of infection. Dengue virus belongs to the Flavavirus group, transmitted by Aedes mosquito and is the most significant mosquito born disease in terms of morbidity and mortality.
6. Human Immunodeficency Virus (HIV) test
   
   One Step Cassette Style Anti-HIV 1+2 Test is a rapid, direct binding-screening test for the presence of antibodies to HIV 1 and HIV 2 viruses. It is used as an aid in the diagnosis of HIV infection. This test is based on the principle of inter-second antibody gold conjugated immunoassay for the determination of anti-HIV-1 and anti-HIV-2 in serum. Recombinant HIV antigens are employed to identify anti-HIV 1 and HIV 2 specifically. This one step test is very sensitive and test results are read visually without any instrument.
7. Hepatitis B test
   
   True BioScience Hepatitis B antigen test products are listed in g1 to g7. These tests are categorized as one-step rapid test that are simple to conduct with no additional instrument required. They act as an effective screening and diagnosis of Hepatitis B infections and immunities. Results can easily be read visually in just 10 to 20 minutes.
   
   

   g1. Hepatitis B Surface Antigen (HBsAG) test

   g2. Hepatitis B ‘e’ Antigen (HBeAG) test

   g3. Anti-Hepatitis B Surface Antigen (Anti-HBs) test

   g4. Anti-Hepatitis B ‘e’ Antigen (Anti-HBe) test

   g5. Anti-Hepatitis B Core Antigen (Anti-HBc) test

   g6. Anti-Hepatitis B Core IgM Antigen (Anti-HBcIgM) test

   g7. Hepatitis B panel test

   This all-in-one panel consist 5 types of Hepatitis B antigen tests: HBsAG, HBeAG, Anti-HBs, Anti-HBe and Anti-HBc. The objective of this panel is to reveal multiple test results at a glance, expediting screening process and cutting short diagnosis time.

   Hepatitis B Panel

   
   
8. Anti-Hepatitis C Antigen (Anti-HCV) test
   
   One step Anti-HCV test is a rapid, direct binding screening test that detects presence of antibodies to HCV viruses. It is used as an aid in the diagnosis of hepatitis C infection. This test is based on the principle of double antigen sandwich immunoassay for the determination of anti-HCV in the specimen. It is very sensitive and results can easily be read visually in just 10 to 20 minutes.

INFECTIOUS DISEASE TEST KITS (1)
Classification	One-Step Chlamydia test	One-Step Helicobacter pylori (H. pylori) test	Syphilis test
Test format
Test medium	Swab	Serum / Whole Blood
Certifying bodies
Product insert	Chlamydia test insert	H. pylori test insert	Syphilis test insert
Enquiry	Click
* For more details on country of use, pleasecontact True BioScience

INFECTIOUS DISEASE TEST KITS (2)
Classification	Malaria test	Dengue test	HIV test
Test format
Test medium	Serum / Plasma / Whole Blood	Serum
Certifying bodies	From MRI to IMR
Product insert	Malaria test insert	Dengue test insert	HIV test insert
Enquiry	Click
* For more details on country of use/ certifying body, please contact True BioScience.

4. Drugs of Abuse

1. Amphetamine test
   

   One Step Amphetamine Test is a fast and qualitative visually read immunoassay for screening without the use of any instrument. The method employs a unique monoclonal antibody to selectively identify amphetamine and its metabolites in test urine at or above the concentration of 1000 ng/mL. It is not intended to monitor drug levels, but only to screen urine for the presence of amphetamine and its metabolites.

   mphetamine is a sympathomimetic amine whose biological effects include potent central nervous system stimulation, appetite reduction, hyperthermia, insomnia, increase in heart rate, increase in blood pressure, and the feeling of euphoria. Amphetamines are readily absorbed from the gastrointestinal tract. They are then either deactivated by the liver or excreted in its unchanged form in the urine. Amphetamine is metabolized into deaminated hippuric and benzoic acids and hydroxylated metabolites.

2. Cocaine test
   

   One Step Cocaine Test is a fast, easy to use and visually read immunoassay test without the need for any instrument. The test system employs unique monoclonal antibodies to selectively identify cocaine and its metabolites in urine samples with a high degree of sensitivity. The cut off concentration for cocaine and its metabolites is 300 ng/mL. It is not intended to monitor drug levels, but only to screen urine for the presence of cocaine and its metabolites.

   Cocaine is an alkaloid found in the leaves of a coca plant. It has been used medicinally as an anesthetic agent, but its addictive property has minimized its modern daily use. As a potent central nervous system stimulant, cocaine has been defined as a controlled substance by most governments.

3. Morphine / Opiate test
   
   One Step Morphine/ Opiate Test is a fast, easy to use and visually read immunoassay test without the need of any instrument. The test system employs unique monoclonal antibodies to selectively identify morphine in urine samples with a high degree of sensitivity. The cut off concentration for morphine is 300 ng/ml. It is not intended to monitor drug levels, but only to screen urine samples for the presence of morphine.
   
   The opiates such as heroin, morphine, and codeine are derived from the resin of the opium poppy. Morphine and morphine glucuronide might both be found in the urine sample of a person who has taken morphine. Heroin and Codeine are quickly metabolized to morphine in the body. The presence of morphine or the metabolite, morphine glucuronide, in urine, is an indication of heroin, morphine and/or codeine use.
4. Marijuana / Cannibas (THC) test
   
   The THC test is an immunochromatography device based on the principle of competitive immunoassay. The nitrocellulose membrane of the dipstick is immobilized with THC-protein conjugate on the test zone. Antibodies against THC which have been conjugated with colloidal gold are impregnated on a porous pad overlapping the bottom end of the membrane.
   
   THC, psychoactive component of marijuana is a central system stimulant relaxant. THC in marijuana is strongly absorbed by fatty tissues in various organs and a metabolite form of THC, delta-9-tetrahydrocannabinol, is present is the urine after a smoking section which denotes a marijuana user.
5. Methamphetamine (MET) test
   
   This MET test is a fast, qualitative and visually read immunoassay for easy screening without the use of any instrument. The method employs a unique monoclonal antibody to selectively identify methamphetamine and its metabolites in test urine at or above the concentration of 1000 ng/mL.
   
   Methamphetamines are central nervous system stimulants that produce the feeling of alertness, wakefulness, increased energy, reduced hunger, and general well being. Methamphetamine increases tolerance and physiological dependence in a person, leading to its abuse.

DRUGS OF ABUSE TEST KITS
Classification	Amphetamine test	Cocaine test	Morphine / Opiate / Heroin test	Marijuana / Cannabis (THC) test	Methamphe- tamine (MET) test
Test format
Test medium	Urine
Certifying bodies*
Product insert	Amphetamine test insert	Cocaine test insert	Morphine/ opiate/Heroin test insert	Marijuana/ cannabis test insert	Methamphe- tamine test insert
Enquiry	Click
* For more details on certifying body, please contact True BioScience.

6. Drugs of Abuse Panel test
   
   True BioScience caters for different application needs with different drugs of abuse format types. Urine dip panel tests are extremely useful and convenient for the law enforcement agencies to perform immediate test on suspected drugs abusers with accurate result revealing in minutes. Please click here for enquiry.
   

   DOA Dip Type 3 DOA Type A DOA Dip Type 5

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5. Fertility

1. Pregnancy hCG  test (99% Accurate)

   One step human Chroionic  Gonadotropin (hCG) pregnancy kit detects the presence of hCG in the serum or urinespecimen. The appearance of hCG Is inevitable soon after conception, and its subsequent rapid rise in concentration during early gestational growth.

This test is used to obtain a visual, qualitative result for the early detection of pregnancy.

2. LH Ovulation  test
   

   One Step LH Ovulation Test is a qualitative test to determine urine specimens, accurately revealing on when there is a LH (Luteinizing Hormone) surge, and in turn when you are likely to ovulate.Y ou must determine the length of your menstrual cycle. This is the number of days from the first day of your menstrual bleeding to the day before your next bleeding begins again. Please refer to the chart in the product insert to determine when you should start testing. If your cycle is shorter than 21 days or longer than 38 days, consult your doctor. If you do not know your cycle length, you may begin the test 11 days after your first period since the average cycle length is 28 days. Perform 1 test each day over a 5-day period or until the LH surge has been detected.
   
   Test mediums available: Test cassette and Midstream

3. FSH Menopause test
   

   One Step Cassette Style FSH Urine Test is a test kit for the determination of FSH (human Follicular Stimulating Hormone) concentration in urine specimens. An elevated FSH level is an indication of the onset of menopause. Test results are read visually without the need for any instrument. It is accurate, fast and easy to use.
   
   Test mediums available: Test cassette and Midstream

FERTILITY
Classification	Pregnancy hCG test	LH Ovulation test	FSH Menopause test
Test format
Test medium	Urine
Certifying bodies
Product insert	hCG test insert	LH Ovulation test insert	FSH Menopause test insert
Enquiry	Click
* For more details on the certifying bodies, please contact True BioScience.

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6. Urinalysis reagents strips

Urinalysis reagents strips are frontline quick screening aids that effectively assist in revealing diseases which might have gone unnoticed without any signs or symptoms. It is an effective tool for early detection and act like a pre-warning of upcoming diseases simply by using urine specimen.

A wide range of 1 to 11 parameters reagents strips are available for selection.

Glucose, Bilirubin, Ketone, Specific Gravity, pH, Blood, Protein, Urobilinogen, Nitrite, Leukocytes & Ascorbic Acid

Results are read visually by comparing it with a chart or for those who prefer a printout of the test results, we offer True BioScience URS Analyzer.

Our URS Analyser is portable, simple and hassle free to operate. With a touch of a button, results can be printed out with its detected level of each parameter.

Please click here for enquiry.

URS 10 Parameters URS Analyser

Comparison Chart

7. Customized kits 

We are able to customized kit suitable for your needs. Our R&D team is able
to provide sound support and technical expertise tailored to your requirements.
Do contact us: enquiry@truebioscience.com

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