A quick accurate diagnosis will lead to early treatment and more - - PDF document

Rapid Test Kits Malaria, Dengue, HIV 1&2 (P24 Ag), 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

• nly when needed.

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Simple to use

Tests can be performed anywhere at any time without the need for costly infrastructure

Cost effective

Easy to perform and a short turnover time makes it a test of choice particularly in a resource-limited

• setup. Without the

need for expensive laboratory resources.

Fast results

These methods significantly reduce the time for identification from days to minutes compared with conventional techniques

Suitable for self-testing

Clear instructions make the tests easy to self administer giving a result in a few minutes, eliminating the stress of waiting days for results

Reliable results

HCS Rapid Test Kits have undergone extensive clinical trials and are very accurate and sensitive at detecting infection. With a high level of sensitivity/specificity in excess of 99%

Convenient

Ideal for early detection for recent/acute or chronic infection

A quick accurate diagnosis will lead to early treatment and more importantly break the spread of infection

Malaria P.f. /P.v.

The Malaria P.f./P.v. Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of two kinds of circulating plasmodium falciparum(P.falciparum (P.f.) and P. vivax (P.v.)) in whole blood.

Malaria P.f. /Pan

The Malaria P.f./Pan Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of four kinds of circulating plasmodium falciparum (P. falciparum (P.f.), P. vivax (P.v.),

• P. ovale (P.o.), and P. malariae

(P.m.)) in whole blood.

Our Top Products

Tuberculosis

The Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of anti- TB antibodies (Isotypes IgG, IgM and IgA) in whole blood, serum or plasma specimens.

Syphilis

The Syphilis Rapid Test utilizes a double antigen combination

• f a Syphilis antigen coated

particle and Syphilis antigen immobilizedon membrane to detect TP antibodies (IgG and IgM)qualitatively and selectively in serum or

• plasma. Treponema

Pallidum(TP)is the causative agent of the venereal disease Syphilis

Dengue

NS1 protein, marker of acute

• infection. The Dengue IgG/IgM

Rapid Test (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of Dengue antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component, and an IgM

• component. In the IgG

component, anti-human IgG is coated in IgG test line region.

HIV

This is a test to determine the presence of HIV antibodies in the Human blood. Applicable to all groups including pregnant and neonates. This is a screening test only and all positive results must be followed up with an alternate test and counseling.

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.

HCV

Hepatitis C Virus (HCV) is a small, enveloped, positive- sense, single-stranded RNA

• Virus. HCV is now known to be

the major cause of parenterally transmitted non- A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well- documented non-A, non-B hepatitis.

HBsAg

The HBsAg Rapid Test (Whole Blood/Serum/Plasma)is a rapid test to qualitatively detect the presence of HBsAg in whole blood, serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBsAg in whole blood, serum

• r plasma specimen.

HBsAg/HCV/HIV/Syphilis Combo Rapid Test Cassette (Serum/Plasma)

Test Kit Contents

1 test Cassette 1 Lancet 1 Pipette 1 Alcohol swab 1 Diluent 1 Silicon gel

1 2 3

Instructions

4

Open alcohol swab Clean finger Prick finger with lancet Use the pipette to collect 1 – 2 drops

• f blood

Place 1 drop of blood into the sample well

5 6

Place 1 drop of the diluent into the sample well Read the results 10/15 minutes

7

*Ensure test kit contents are disposed of safely and hygienically after use

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

Point-of-care testing in primary care

WORLDWIDE DISTRIBUTION

V.2. KW

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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

• 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 HBsAg Rapid Test Results Positive Negative Positive 205 3 208 Negative 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 HCV Rapid Test Results Positive Negative Positive 107 3 110 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

• f 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 HIV 1/2 p24 Ag Rapid Test Results Positive Negative Positive 130 2 132 Negative 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 Syphilis Rapid Test Results Positive Negative Positive 130 1 131 Negative 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

Precision Intra-Assay Within-run precision has been determined by using 20 replicates of four different specimens containing different concentrations of HBsAg, HCV antibody, HIV 1/2 p24 Ag antibody and syphilis antibody. The negative, positive values were correctly identified 100% of the time. Inter-Assay Between-run precision has been determined by 20 independent assays on the same four different specimens containing different concentrations of HBsAg, HCV antibody, HIV 1/2 p24 Ag antibody and syphilis antibody. Three specimens: a negative, a HCV low titre positive and a HCV high titer positive. Three different lots of HCS Rapid HBsAg /HCV /HIV /Syphilis Combo Test Cassette (Whole Blood/Serum /Plasma) have been tested over a 3-month period using above negative and positive specimens. The specimens were correctly identified 100% of the time. Cross-reactivity The HBsAg Rapid Test (Whole Blood/Serum/Plasma) has been tested by HAMA, Rheumatoid factor (RF), HAV, and Syphilis, HIV, H. Pylori, MONO, CMV, Rubella, HCV, HEV and TOXO positive specimens. The results showed no cross-reactivity. The HCV Rapid Test (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity. The HIV 1.2Rapid Test (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV, Syphilis, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity. The Syphilis Rapid Test (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive

• specimens. The results showed no cross-reactivity.

Interfering Substances The following potentially interfering substances were added to HBsAg, HCV antibody, HIV 1/2 p24 Ag antibody and syphilis antibody negative and positive specimens. Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL Acetylsalicylic Acid: 20 mg/dL Gertisic Acid: 20 mg/dL Ascorbic Acid: 2g/dL Albumin: 2 g/dL Creatine: 200 mg/dL Haemoglobin: 1000mg/dL Bilirubin: 1g/dL Oxalic Acid: 60mg/dL None of the substances at the concentration tested interfered in the assay. LIMITATIONS

• 1. This test is for in vitro diagnostic use only.
• 2. This test has been developed for testing whole blood/serum/plasma specimens only. The

performance of the test using other specimens has not been substantiated.

• 3. This test is a qualitative screening assay. It is not designed to determine the quantitative

concentration of HBsAg, HCV antibody, HIV 1/2 p24 Ag antibody or syphilis antibody.

• 4. The HBsAg Rapid Test cannot detect less than 1 PEI ng/ml of HBsAg in specimens.
• 5. As with all diagnostic tests, all results must be considered with other clinical information available

to the physician.

• 6. If the test result is negative and clinical symptoms persist, additional follow-up testing using other

clinical methods is recommended. A negative result at any time does not preclude the possibility

• f HBsAg and/or Hepatitis C Virus and/or HIV1.2 and/or syphilis infection.

• 2. Combo for Malaria

PERFORMANCE CHARACTERISTICS Sensitivity HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) has been tested with microscopy on clinical samples. The results show that the sensitivity of HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) is >99.9% when compared to results obtained with microscopy. Specificity HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) uses antibodies that are highly specific to Malaria P.f.-specific and Pan-malarial antigens in whole blood. The results show that the specificity of HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) is >99.9%, when compared to results obtained with microscopy. Method Microscopy Total Results HCS Rapid Malaria P.f. /Pan Test Cassette (WholeBlood) Results Positive Negative

• P. v.
• P. f.

Positive 50* 82** 132 Negative 1 432 433 Total Results 51 82 432 565 Comment: Blood Samples infected by Plasmodium falciparum (n = 82), Plasmodium vivax (n = 51) were included, as well as 432 malaria negative samples to be confirmed with microscopy. Note: * There was one P. vivax sample to show a pan line and a P.f. line. ** There were two P. falciparum samples that they both showed a pan line and a P.f. line. The comparison for Pan Line has been only done with blood specimens positive with Plasmodium vivax specimen. The claims for Pan Lines are based on scientific findings that Pan- malarial Aldolase is found in other malarial parasites including Plasmodium ovale and Plasmodium malariae. Relative Sensitivity for P.f.-specific antigens: 82/82>99.9 %( 95%CI***: 96.4%~100.0%) Relative Sensitivity for Pan-malarial antigens: 50/51= 98.0% (95%CI***: 89.6%~100.0%) Relative Specificity: 432/432>99.9% (95%CI***: 99.3%-100.0%)* Accuracy: (50+82+432)/(82+51+432)=564/565=99.8%(95%CI***: 99.0%-100.0%) ***Confidence Intervals Minimum Detection Level Type Parasites/mL

• P. falciparum

200 Plasmodium non-falciparum species (P. vivax) 1500

Precision Intra-Assay Within-run precision has been determined by using 15 replicates of four specimens: a negative, a P.f. positive, a Pan positive and a P.f. /Pan dual positive. The specimens were correctly identified >99% of the time. Inter-Assay Between-run precision has been determined by 15 independent assays on the same four specimens: negative, a P.f. positive, a Pan positive and an P.f./Pan dual positive. Three different lots of HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) have been tested using these

• specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity. Interfering Substances The following potentially interfering substances were added to Malaria negative and positive specimens. Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL Acetylsalicylic Acid: 20 mg/dL Gertisic Acid: 20 mg/dL Ascorbic Acid: 2g/dL Albumin: 2 g/dL Creatine: 200 mg/dL Bilirubin: 1g/dL Oxalic Acid: 60mg/dL None of the substances at the concentration tested interfered in the assay. LIMITATIONS

• 1. HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) is for in vitro diagnostic use only.

This test should be used for the detection of P.f., P.v., P.o., P.m. antigens in whole blood specimens only. Neither the quantitative value nor the rate of increase in P.f., P.v., P.o., and P.m. concentration can be determined by this qualitative test.

• 2. HCS Rapid Malaria P.f. /Pan Test Cassette(Whole Blood) will only indicate the presence of

antigens of Plasmodium sp. (P.f., P.v., P.o., P.m.) in the specimen and should not be used as the sole criterion for the diagnosis of malaria infection.

• 3. As with all diagnostic tests, all results must be interpreted together with other clinical

information available to the physician.

• 4. If the test result is negative and clinical symptoms persist, additional testing using other

clinical methods is recommended. A negative result does not at any time preclude the possibility

• f malaria infection.

• 3. Tuberculosis

PERFORMANCE CHARACTERISTICS Clinical Sensitivity, Specificity and Accuracy HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) has been calibrated against specimens that have been collected from individuals found to be either smear positive/negative or culture positive/negative. The results show that the relative sensitivity of HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) is 83.8%, the relative specificity is 98.8 % and the relative accuracy is 95.7%. Tuberculosis Rapid Test Cassette vs. Smear/Culture Method Smear/Culture Total Results Tuberculosis Rapid Test Cassette Results Positive Negative Positive 88 5 93 Negative 17 405 422 Total Results 105 410 515 Relative Sensitivity: 88/105=83.8% (95%CI*: 75.3%~90.3%); Relative Specificity: 405/410=98.8% (95%CI*: 97.2%~99.6%); Relative Accuracy: (88+405)/(88+17+5+405)=493/515=95.7% (95%CI*: 93.6%~97.3%). *Confidence Intervals Precision Intra-Assay Within-run precision has been determined by using 20 replicates of four specimens: a negative, a low positive, middle positive and a high positive. The negative, low positive, middle positive, high positive values were correctly identified >99% of the time. Inter-Assay Between-run precision has been determined by 5 independent assays on the same four specimens: The negative, low positive, middle positive, high positive values. Three different lots

• f HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) have been tested using

negative, low positive, middle positive and high positive specimens. The specimens were correctly identified >99% of the time. Cross-Reactivity HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) has been tested with specimens positive for: anti-HIV, pulmonary diseases, anti-CMV, Rheumatoid factor (RF), anti- HCV and specimens from children below 15 years, who have been administered BCG vaccine. No cross-reactivity was observed, indicating that the performance of HCSRapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) is stable in presence of these factors.

Interfering Substances HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) has been tested for possible interference from visibly haemolysed and lipemic specimens, as well as serum specimens containing high bilirubin levels. Results indicate that no interference was observed in specimens containing up to 500 mg/dL haemoglobin; up to 30 mg/dL bilirubin; and up to 2,000 mg/dL human serum albumin. LIMITATIONS

• 1. HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic

use only. The test should be used for the detection of anti-TB antibodies in whole blood, serum

• r plasma specimens. Neither the quantitative value nor the rate of increase in anti-TB antibodies

concentration can be determined by this qualitative test.

• 2. HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) will only indicate the

presence of anti-TB antibodies in the specimen and should not be used as the sole criteria for the diagnosis of active tuberculosis diagnosis.

• 3. As with all diagnostic tests, all results must be considered with other clinical information

available to the physician.

• 4. Dengue IgG/IgM/NS1 Combo

PERFORMANCE CHARACTERISTICS Sensitivity and Specificity HCS Rapid Dengue IgG/IgM/NS1 Combo Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with specimens obtained from a population of symptomatic and asymptomatic

• individuals. Results were confirmed by a leading commercial Dengue ELISA test. The results

show that the overall relative sensitivity for the primary and secondary infection of HCS Rapid Dengue IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is 95.7%, and the relative specificity is >99.9%,and the relative accuracy is 99.3%, and for the HCS Rapid Dengue NS1 Test Cassette (Whole Blood/Serum/Plasma) is 95.8%,and the relative specificity is 96.2%, and the accuracy is 96.1%. Dengue Primary Infection for IgM/IgG test results Method ELISA HCS Rapid Dengue IgG/IgM Test Cassette (Whole Blood/ Serum /Plasma) Results Positive negative IgM IgG Positive IgM 15 IgG 3 Negative Relative Sensitivity 83.3% / / Dengue Secondary Infection for IgM/IgG test results Method ELISA HCS Rapid Dengue IgG/IgM Test Cassette (Whole Blood/ Serum /Plasma) Results Positive negative IgM IgG Positive IgM 37 IgG 15 52 Negative Relative Sensitivity 71.2% >99.9% / Non-Dengue Infection for IgM/IgG test results Method ELISA HCS Rapid Dengue NS1 Test Cassette (Whole Blood/ Serum /Plasma) Results Positive negative IgM IgG Positive IgM IgG Negative 338 Relative Specificity / / >99.9% Relative sensitivity: (15+52)/ (18+52) =95.7% (95%CI*: 88.0%~99.1%); Relative specificity: 338/338>99.9% (95%CI*: 99.1%~100.0%); Accuracy: (15+52+338)/ (18+52+338) =99.3% (95%CI*: 97.9%~99.8%). *Confidence Intervals

Method Dengue Ag ELISA Test Total Result HCS Rapid Dengue NS1 Test Cassette (Whole Blood /Serum /Plasma) Results Positive Negative Positive 69 4 73 Negative 3 102 105 Total Result 72 106 178 Relative sensitivity: 69/72*100%=95.8% (95%CI*: 88.3%~99.1%); Relative specificity: 102/106*100%=96.2% (95%CI*: 90.6%~99.0%); Accuracy :( 69+102)/(69+3+4+102)*100%=96.1% (95%CI*:92.1%~98.4%) *Confidence Intervals Precision Intra-Assay Within-run precision has been determined by using 15 replicates of four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. The specimens were correctly identified >99% of the time. Inter-Assay Between-run precision has been determined by 15 independent assays on the same four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. Three different lots of HCS Rapid Dengue Test Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time. Cross-reactivity HCSRapid Dengue IgG/IgM/NS1 Combo Test Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity. Interfering Substances The following potentially interfering substances were added to Dengue negative and positive specimens. Acetaminophen: 20 mg/Dl Caffeine: 20 mg/dL Acetylsalicylic Acid: 20 mg/dL Gertisic Acid: 20 mg/dL Ascorbic Acid: 2g/dL Albumin: 2 g/dL Creatine: 200 mg/dL Oxalic Acid: 60mg/dL None of the substances at the concentration tested interfered in the assay.

LIMITATIONS

• 1. HCS Rapid Dengue IgG/IgM/NS1 Combo Test Cassette (Whole Blood/Serum/Plasma) is for in

vitro diagnostic use only. The test should be used for the detection of Dengue antibodies and NS1 antigen in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Dengue antibody and NS1 antigen concentration can be determined by this qualitative test.

• 2. In the early onset of fever, anti-Dengue IgM concentrations may be below detectable levels.

For primary infection, an IgM antibody-capture enzyme-linked immune-sorbent assay (MAC- ELISA) showed that 80% of the Dengue patients tested exhibited detectable levels of IgM antibody by the fifth day after infection, and 99% of the patients tested IgM positive by day 10. It is recommended that patients be tested within this time. For the secondary infection, a low molar fraction of anti-Dengue IgM and a high molar fraction of IgG that is broadly reactive to flavivirus characterize the antibodies. 5 The IgM signal may be faint and the cross reaction in the region of IgG line may appear.

• 3. Serological cross-reactivity across the flavivirus group (Dengue 1, 2, 3 & 4, St. Louis

encephalitis, West Nile virus, Japanese encephalitis and yellow fever viruses) is common.6,7,8 Positive results should be confirmed by other means.

• 4. The continued presence or absence of antibodies and NS1 antigen cannot be used to

determine the success or failure of therapy.

• 5. As with all diagnostic tests, all results must be interpreted together with other clinical

information available to the physician.

• 6. If the test result is negative and clinical symptoms persist, additional testing using other clinical

methods is recommended. A negative result does not at any time preclude the possibility of Dengue infection.

• 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 HBsAg Rapid Test Results Positive Negative Positive 205 3 208 Negative 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 HCV Rapid Test Results Positive Negative Positive 107 3 110 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

• f 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 HIV 1/2 p24 Ag Rapid Test Results Positive Negative Positive 130 2 132 Negative 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 Syphilis Rapid Test Results Positive Negative Positive 130 1 131 Negative 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

Precision Intra-Assay Within-run precision has been determined by using 20 replicates of four different specimens containing different concentrations of HBsAg, HCV antibody, HIV 1/2 p24 Ag antibody and syphilis antibody. The negative, positive values were correctly identified 100% of the time. Inter-Assay Between-run precision has been determined by 20 independent assays on the same four different specimens containing different concentrations of HBsAg, HCV antibody, HIV 1/2 p24 Ag antibody and syphilis antibody. Three specimens: a negative, a HCV low titre positive and a HCV high titer positive. Three different lots of HCS Rapid HBsAg /HCV /HIV /Syphilis Combo Test Cassette (Whole Blood/Serum /Plasma) have been tested over a 3-month period using above negative and positive specimens. The specimens were correctly identified 100% of the time. Cross-reactivity The HBsAg Rapid Test (Whole Blood/Serum/Plasma) has been tested by HAMA, Rheumatoid factor (RF), HAV, and Syphilis, HIV, H. Pylori, MONO, CMV, Rubella, HCV, HEV and TOXO positive specimens. The results showed no cross-reactivity. The HCV Rapid Test (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity. The HIV 1.2Rapid Test (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV, Syphilis, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity. The Syphilis Rapid Test (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive

• specimens. The results showed no cross-reactivity.

Interfering Substances The following potentially interfering substances were added to HBsAg, HCV antibody, HIV 1/2 p24 Ag antibody and syphilis antibody negative and positive specimens. Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL Acetylsalicylic Acid: 20 mg/dL Gertisic Acid: 20 mg/dL Ascorbic Acid: 2g/dL Albumin: 2 g/dL Creatine: 200 mg/dL Haemoglobin: 1000mg/dL Bilirubin: 1g/dL Oxalic Acid: 60mg/dL None of the substances at the concentration tested interfered in the assay. LIMITATIONS

• 1. This test is for in vitro diagnostic use only.
• 2. This test has been developed for testing whole blood/serum/plasma specimens only. The

performance of the test using other specimens has not been substantiated.

• 3. This test is a qualitative screening assay. It is not designed to determine the quantitative

concentration of HBsAg, HCV antibody, HIV 1/2 p24 Ag antibody or syphilis antibody.

• 4. The HBsAg Rapid Test cannot detect less than 1 PEI ng/ml of HBsAg in specimens.
• 5. As with all diagnostic tests, all results must be considered with other clinical information available

to the physician.

• 6. If the test result is negative and clinical symptoms persist, additional follow-up testing using other

clinical methods is recommended. A negative result at any time does not preclude the possibility

• f HBsAg and/or Hepatitis C Virus and/or HIV1.2 and/or syphilis infection.

• 2. Combo for Malaria

PERFORMANCE CHARACTERISTICS Sensitivity HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) has been tested with microscopy on clinical samples. The results show that the sensitivity of HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) is >99.9% when compared to results obtained with microscopy. Specificity HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) uses antibodies that are highly specific to Malaria P.f.-specific and Pan-malarial antigens in whole blood. The results show that the specificity of HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) is >99.9%, when compared to results obtained with microscopy. Method Microscopy Total Results HCS Rapid Malaria P.f. /Pan Test Cassette (WholeBlood) Results Positive Negative

• P. v.
• P. f.

Positive 50* 82** 132 Negative 1 432 433 Total Results 51 82 432 565 Comment: Blood Samples infected by Plasmodium falciparum (n = 82), Plasmodium vivax (n = 51) were included, as well as 432 malaria negative samples to be confirmed with microscopy. Note: * There was one P. vivax sample to show a pan line and a P.f. line. ** There were two P. falciparum samples that they both showed a pan line and a P.f. line. The comparison for Pan Line has been only done with blood specimens positive with Plasmodium vivax specimen. The claims for Pan Lines are based on scientific findings that Pan- malarial Aldolase is found in other malarial parasites including Plasmodium ovale and Plasmodium malariae. Relative Sensitivity for P.f.-specific antigens: 82/82>99.9 %( 95%CI***: 96.4%~100.0%) Relative Sensitivity for Pan-malarial antigens: 50/51= 98.0% (95%CI***: 89.6%~100.0%) Relative Specificity: 432/432>99.9% (95%CI***: 99.3%-100.0%)* Accuracy: (50+82+432)/(82+51+432)=564/565=99.8%(95%CI***: 99.0%-100.0%) ***Confidence Intervals Minimum Detection Level Type Parasites/mL

• P. falciparum

200 Plasmodium non-falciparum species (P. vivax) 1500

Precision Intra-Assay Within-run precision has been determined by using 15 replicates of four specimens: a negative, a P.f. positive, a Pan positive and a P.f. /Pan dual positive. The specimens were correctly identified >99% of the time. Inter-Assay Between-run precision has been determined by 15 independent assays on the same four specimens: negative, a P.f. positive, a Pan positive and an P.f./Pan dual positive. Three different lots of HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) have been tested using these

• specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity. Interfering Substances The following potentially interfering substances were added to Malaria negative and positive specimens. Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL Acetylsalicylic Acid: 20 mg/dL Gertisic Acid: 20 mg/dL Ascorbic Acid: 2g/dL Albumin: 2 g/dL Creatine: 200 mg/dL Bilirubin: 1g/dL Oxalic Acid: 60mg/dL None of the substances at the concentration tested interfered in the assay. LIMITATIONS

• 1. HCS Rapid Malaria P.f. /Pan Test Cassette (Whole Blood) is for in vitro diagnostic use only.

This test should be used for the detection of P.f., P.v., P.o., P.m. antigens in whole blood specimens only. Neither the quantitative value nor the rate of increase in P.f., P.v., P.o., and P.m. concentration can be determined by this qualitative test.

• 2. HCS Rapid Malaria P.f. /Pan Test Cassette(Whole Blood) will only indicate the presence of

antigens of Plasmodium sp. (P.f., P.v., P.o., P.m.) in the specimen and should not be used as the sole criterion for the diagnosis of malaria infection.

• 3. As with all diagnostic tests, all results must be interpreted together with other clinical

information available to the physician.

• 4. If the test result is negative and clinical symptoms persist, additional testing using other

clinical methods is recommended. A negative result does not at any time preclude the possibility

• f malaria infection.

• 3. Tuberculosis

PERFORMANCE CHARACTERISTICS Clinical Sensitivity, Specificity and Accuracy HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) has been calibrated against specimens that have been collected from individuals found to be either smear positive/negative or culture positive/negative. The results show that the relative sensitivity of HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) is 83.8%, the relative specificity is 98.8 % and the relative accuracy is 95.7%. Tuberculosis Rapid Test Cassette vs. Smear/Culture Method Smear/Culture Total Results Tuberculosis Rapid Test Cassette Results Positive Negative Positive 88 5 93 Negative 17 405 422 Total Results 105 410 515 Relative Sensitivity: 88/105=83.8% (95%CI*: 75.3%~90.3%); Relative Specificity: 405/410=98.8% (95%CI*: 97.2%~99.6%); Relative Accuracy: (88+405)/(88+17+5+405)=493/515=95.7% (95%CI*: 93.6%~97.3%). *Confidence Intervals Precision Intra-Assay Within-run precision has been determined by using 20 replicates of four specimens: a negative, a low positive, middle positive and a high positive. The negative, low positive, middle positive, high positive values were correctly identified >99% of the time. Inter-Assay Between-run precision has been determined by 5 independent assays on the same four specimens: The negative, low positive, middle positive, high positive values. Three different lots

• f HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) have been tested using

negative, low positive, middle positive and high positive specimens. The specimens were correctly identified >99% of the time. Cross-Reactivity HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) has been tested with specimens positive for: anti-HIV, pulmonary diseases, anti-CMV, Rheumatoid factor (RF), anti- HCV and specimens from children below 15 years, who have been administered BCG vaccine. No cross-reactivity was observed, indicating that the performance of HCSRapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) is stable in presence of these factors.

Interfering Substances HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) has been tested for possible interference from visibly haemolysed and lipemic specimens, as well as serum specimens containing high bilirubin levels. Results indicate that no interference was observed in specimens containing up to 500 mg/dL haemoglobin; up to 30 mg/dL bilirubin; and up to 2,000 mg/dL human serum albumin. LIMITATIONS

• 1. HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic

use only. The test should be used for the detection of anti-TB antibodies in whole blood, serum

• r plasma specimens. Neither the quantitative value nor the rate of increase in anti-TB antibodies

concentration can be determined by this qualitative test.

• 2. HCS Rapid Tuberculosis Test Cassette (Whole Blood/Serum/Plasma) will only indicate the

presence of anti-TB antibodies in the specimen and should not be used as the sole criteria for the diagnosis of active tuberculosis diagnosis.

• 3. As with all diagnostic tests, all results must be considered with other clinical information

available to the physician.

• 4. Dengue IgG/IgM/NS1 Combo

PERFORMANCE CHARACTERISTICS Sensitivity and Specificity HCS Rapid Dengue IgG/IgM/NS1 Combo Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with specimens obtained from a population of symptomatic and asymptomatic

• individuals. Results were confirmed by a leading commercial Dengue ELISA test. The results

show that the overall relative sensitivity for the primary and secondary infection of HCS Rapid Dengue IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is 95.7%, and the relative specificity is >99.9%,and the relative accuracy is 99.3%, and for the HCS Rapid Dengue NS1 Test Cassette (Whole Blood/Serum/Plasma) is 95.8%,and the relative specificity is 96.2%, and the accuracy is 96.1%. Dengue Primary Infection for IgM/IgG test results Method ELISA HCS Rapid Dengue IgG/IgM Test Cassette (Whole Blood/ Serum /Plasma) Results Positive negative IgM IgG Positive IgM 15 IgG 3 Negative Relative Sensitivity 83.3% / / Dengue Secondary Infection for IgM/IgG test results Method ELISA HCS Rapid Dengue IgG/IgM Test Cassette (Whole Blood/ Serum /Plasma) Results Positive negative IgM IgG Positive IgM 37 IgG 15 52 Negative Relative Sensitivity 71.2% >99.9% / Non-Dengue Infection for IgM/IgG test results Method ELISA HCS Rapid Dengue NS1 Test Cassette (Whole Blood/ Serum /Plasma) Results Positive negative IgM IgG Positive IgM IgG Negative 338 Relative Specificity / / >99.9% Relative sensitivity: (15+52)/ (18+52) =95.7% (95%CI*: 88.0%~99.1%); Relative specificity: 338/338>99.9% (95%CI*: 99.1%~100.0%); Accuracy: (15+52+338)/ (18+52+338) =99.3% (95%CI*: 97.9%~99.8%). *Confidence Intervals

Method Dengue Ag ELISA Test Total Result HCS Rapid Dengue NS1 Test Cassette (Whole Blood /Serum /Plasma) Results Positive Negative Positive 69 4 73 Negative 3 102 105 Total Result 72 106 178 Relative sensitivity: 69/72*100%=95.8% (95%CI*: 88.3%~99.1%); Relative specificity: 102/106*100%=96.2% (95%CI*: 90.6%~99.0%); Accuracy :( 69+102)/(69+3+4+102)*100%=96.1% (95%CI*:92.1%~98.4%) *Confidence Intervals Precision Intra-Assay Within-run precision has been determined by using 15 replicates of four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. The specimens were correctly identified >99% of the time. Inter-Assay Between-run precision has been determined by 15 independent assays on the same four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. Three different lots of HCS Rapid Dengue Test Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time. Cross-reactivity HCSRapid Dengue IgG/IgM/NS1 Combo Test Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity. Interfering Substances The following potentially interfering substances were added to Dengue negative and positive specimens. Acetaminophen: 20 mg/Dl Caffeine: 20 mg/dL Acetylsalicylic Acid: 20 mg/dL Gertisic Acid: 20 mg/dL Ascorbic Acid: 2g/dL Albumin: 2 g/dL Creatine: 200 mg/dL Oxalic Acid: 60mg/dL None of the substances at the concentration tested interfered in the assay.

LIMITATIONS

• 1. HCS Rapid Dengue IgG/IgM/NS1 Combo Test Cassette (Whole Blood/Serum/Plasma) is for in

vitro diagnostic use only. The test should be used for the detection of Dengue antibodies and NS1 antigen in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Dengue antibody and NS1 antigen concentration can be determined by this qualitative test.

• 2. In the early onset of fever, anti-Dengue IgM concentrations may be below detectable levels.

For primary infection, an IgM antibody-capture enzyme-linked immune-sorbent assay (MAC- ELISA) showed that 80% of the Dengue patients tested exhibited detectable levels of IgM antibody by the fifth day after infection, and 99% of the patients tested IgM positive by day 10. It is recommended that patients be tested within this time. For the secondary infection, a low molar fraction of anti-Dengue IgM and a high molar fraction of IgG that is broadly reactive to flavivirus characterize the antibodies. 5 The IgM signal may be faint and the cross reaction in the region of IgG line may appear.

• 3. Serological cross-reactivity across the flavivirus group (Dengue 1, 2, 3 & 4, St. Louis

encephalitis, West Nile virus, Japanese encephalitis and yellow fever viruses) is common.6,7,8 Positive results should be confirmed by other means.

• 4. The continued presence or absence of antibodies and NS1 antigen cannot be used to

determine the success or failure of therapy.

• 5. As with all diagnostic tests, all results must be interpreted together with other clinical

information available to the physician.

• 6. If the test result is negative and clinical symptoms persist, additional testing using other clinical

methods is recommended. A negative result does not at any time preclude the possibility of Dengue infection.