rapid-test-kits.com admin@ Rapid-test-kits.com Rapid Test Kits Malaria, Dengue, HIV 1&2 (P24 A g), Tuberculosis, Syphilis, HBsAg & HCV & Combination Medical diagnostic tests that are quick and easy to perform. Suitable for preliminary or emergency medical screening and for use in medical facilities with limited resources Our aim Is to allow point-of- care testing in primary care for things that formerly only a laboratory test could measure Our kits deliver important diagnostic results to clinicians in minutes so patients receive answers and appropriate treatment quickly. This aids in preventing the spread of infectious diseases and enables physicians to prescribe treatment only when needed.
A quick accurate diagnosis will lead to early treatment and more importantly break the spread of infection Simple to use Cost effective Fast results Tests can be Easy to perform and a These methods performed short turnover time significantly reduce anywhere at any makes it a test of the time for time without the choice particularly in identification from need for costly a resource-limited days to minutes infrastructure setup. Without the compared with need for expensive conventional laboratory resources. techniques Suitable for Reliable results Convenient self-testing HCS Rapid Test Kits Ideal for early have undergone detection for Clear instructions extensive clinical recent/acute or make the tests easy trials and are very chronic infection to self administer accurate and giving a result in a sensitive at few minutes, detecting infection. eliminating the With a high level of stress of waiting sensitivity/specificity days for results in excess of 99% Our Top Products Malaria P.f. /P.v. Malaria P.f. /Pan The Malaria P.f./P.v. Rapid Test The Malaria P.f./Pan Rapid Test Cassette (Whole Blood) is a Cassette (Whole Blood) is a rapid chromatographic rapid chromatographic immunoassay for the immunoassay for the qualitative detection of two qualitative detection of four kinds of circulating kinds of circulating plasmodium plasmodium falciparum (P. falciparum(P.falciparum (P.f.) falciparum (P.f.), P. vivax (P.v.), and P. vivax (P.v.)) in whole P. ovale (P.o.), and P. malariae blood. (P.m.)) in whole blood.
Dengue Syphilis NS1 protein, marker of acute The Syphilis Rapid Test utilizes infection. The Dengue IgG/IgM a double antigen combination Rapid Test (Whole of a Syphilis antigen coated Blood/Serum/Plasma) is a particle and Syphilis antigen qualitative membrane-based immobilizedon membrane to immunoassay for the detect TP antibodies (IgG and detection of Dengue IgM)qualitatively and antibodies in whole blood, selectively in serum or serum, or plasma. This test plasma. Treponema consists of two components, Pallidum ( TP )is the causative an IgG component, and an IgM agent of the venereal disease component. In the IgG Syphilis component, anti-human IgG is coated in IgG test line region. Tuberculosis HIV The Tuberculosis Rapid Test This is a test to determine the Cassette (Whole presence of HIV antibodies in Blood/Serum/Plasma) is a the Human blood. Applicable rapid chromatographic to all groups including immunoassay for the pregnant and neonates. This is qualitative detection of anti- a screening test only and all TB antibodies (Isotypes IgG, positive results must be IgM and IgA) in whole blood, followed up with an alternate serum or plasma specimens. test and counseling.
HBsAg HCV The HBsAg Rapid Test (Whole Hepatitis C Virus (HCV) is a Blood/Serum/Plasma)is a small, enveloped, positive- rapid test to qualitatively sense, single-stranded RNA detect the presence of HBsAg Virus. HCV is now known to be in whole blood, serum or the major cause of plasma specimen. The test parenterally transmitted non- utilizes a combination of A, non-B hepatitis. Antibody to monoclonal and polyclonal HCV is found in over 80% of antibodies to selectively patients with well- detect elevated levels of documented non-A, non-B HBsAg in whole blood, serum hepatitis. or plasma specimen. HBsAg/HCV/HIV/Syphilis Combo Rapid Test Cassette (Serum/Plasma) The HBsAg/HCV/HIV/Syphilis Combo Rapid Test Cassette(Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg), antibodies to Hepatitis C Virus, antibodies to HIV type 1, type 2 and syphilis antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma.
Test Kit Contents 1 test Cassette 1 Lancet 1 Pipette 1 Alcohol swab 1 Diluent 1 Silicon gel Instructions 1 2 3 4 Open alcohol Clean finger Prick finger with Use the pipette to collect 1 – 2 drops swab lancet of blood 6 *Ensure test kit 5 7 contents are disposed of safely and hygienically after use Place 1 drop of Place 1 drop of Read the results blood into the the diluent into 10/15 minutes sample well the sample well
Result- Reactive/Positive sample Sample control line Sample test line appears if test is reactive positive Whole blood diluent added Combination Test Kit 1 drop of serum/plasma 1 drop of diluent/buffer
Limitation & Performance Data Characteristics Blood Borne Test (HIV/HBV/HCV & Syphilis) Sensitivity and Specificity Appendix 1 Combo for Malaria Sensitivity and Specificity Appendix 2 Tuberculosis Clinical Sensitivity, Specificity and Accuracy Appendix 3 Dengue IgG/IgM/NS1 Combo Sensitivity and Specificity Appendix 4 Point-of-care testing in primary care WORLDWIDE DISTRIBUTION rapid-test-kits.com admin@rapid-test-kits.com V. 2 . KW
1. Blood Borne Test (HIV/HBV/HCV & Syphilis) PERFORMANCE CHARACTERISTICS Sensitivity and Specificity 1. HBsAg The HBsAg Rapid Test (Whole Blood/Serum/Plasma) has been tested with a sensitivity panel ranging from 0 to 300ng/ml. All 10 HBsAg subtypes produced positive results on The HBsAg Rapid Test (Whole Blood/Serum/Plasma). The test can detect 1 PEI ng/ml of HBsAg in whole blood/serum/plasma. Antibodies used for the HBsAg Rapid Test (Whole Blood/Serum/Plasma) were developed against whole Hepatitis B antigen isolated from Hepatitis B virus. Specificity of the HBsAg Rapid Test (Whole Blood/Serum/Plasma) was also tested with laboratory strains of Hepatitis A and Hepatitis C. They all yielded negative results. Method EIA Total Results Results Positive Negative HBsAg Rapid Test Positive 205 3 208 Negative 0 310 310 Total Results 205 313 518 Relative Sensitivity: >99.9% (97.5%CI*: 98.2%-100%) Relative Specificity: 99.0% (95%CI*: 97.2%-99.8%) Accuracy: 99.4% (95%CI*: 98.3%-99.9%) *Confidence Intervals 2. HCV The recombinant antigen used for the HCV Rapid Test (Whole Blood/Serum/Plasma) is encoded by genes for both structural (nucleo-capsid) and non-structural proteins. The HCV Rapid Test (Whole Blood/Serum/Plasma) has passed a sero-conversion panel and compared with a leading commercial HCV EIA test using clinical specimens. The results show that the relative sensitivity of the HCV Rapid Test Cassette (Whole Blood/Serum/Plasma) is 99.1%, and the relative specificity is 99.5%. Method EIA Total Results Positive Negative Results HCV Rapid Positive 107 3 110 Test Negative 1 599 600 Total Result 108 602 710 Relative sensitivity: 99.1% (95%CI*: 94.9%~100.0%); Relative specificity: 99.5% (95%CI*: 98.6%~99.9%);
Accuracy: 99.4% (95%CI*: 98.6%~99.8%). *Confidence Interval PERFORMANCE CHARACTERISTICS Sensitivity and Specificity 3. HIV 1/2 p24 Ag The HIV 1/2 p24 Ag Rapid Test(Whole Blood/Serum/Plasma) has correctly identified specimens of a sero-conversion panel and has been compared to a leading commercial ELISA HIV test using clinical specimens. The results show that the relative sensitivity of the HIV 1/2 p24 Ag Rapid Test (Whole Blood/Serum/Plasma) is >99.99% and the relative specificity is 99.88%. Method ELISA Total Results Results Positive Negative HIV 1/2 p24 Ag Rapid Positive 130 2 132 Test Negative 0 1683 1683 Total Result 130 1685 1815 Relative sensitivity: >99.99% (97.5%CI*: 97.20%~100.0%); Relative specificity: 99.88% (95%CI*: 99.57%~99.99%); Accuracy: 99.89% (95%CI*: 99.60%~99.99%). *Confidence Intervals 4. Syphilis The Syphilis Rapid Test (Whole Blood/Serum/Plasma) has correctly identified specimens of a sero-conversion panel and has been compared to a leading commercial TPPA Syphilis test using clinical specimens. The results show that the relative sensitivity of the Syphilis Rapid Test (Whole Blood/Serum/Plasma) is >99.9% and the relative specificity is 99.7%. Method TPPA Total Results Results Positive Negative Syphilis Positive 130 1 131 Rapid Test Negative 0 299 299 Total Result 130 300 430 Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%); Relative specificity: 99.7% (95%CI*: 98.2%~100.0%); Accuracy: 99.8% (95%CI*: 98.2%~100.0%). *Confidence Intervals
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