Home | Rapid Test Kits · Title: PowerPoint Presentation Author: Keith Created Date: 5/24/2019 10:29:12 AM

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

Tuberculosis, Syphilis, HBsAg & HCV

& CombinationMedical 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.

rapid-test-kits.comadmin@ Rapid-test-kits.com

Simple to useTests can be performed anywhere at any time without the need for costly infrastructure

Cost effectiveEasy to perform and a short turnover time makes it a test of choice particularly in a resource-limited setup. Without the need for expensivelaboratory resources.

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

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

Reliable resultsHCS 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%

ConvenientIdeal 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 chromatographicimmunoassay 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. /PanThe Malaria P.f./Pan Rapid Test Cassette (Whole Blood) is a rapid chromatographicimmunoassay 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.

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TuberculosisThe 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.

SyphilisThe Syphilis Rapid Test utilizes a double antigen combination of 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

DengueNS1 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.

HIVThis 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 arapid chromatographic immunoassay for the qualitative detection of Hepatitis Bsurface antigen (HBsAg), antibodies to Hepatitis C Virus, antibodies to HIV type1, type 2 and syphilis antibodies (IgG and IgM) to Treponema Pallidum (TP) inserum or plasma.

HCVHepatitis 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.

HBsAgThe 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 or plasma specimen.

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

Test Kit Contents

1 test Cassette1 Lancet1 Pipette1 Alcohol swab1 Diluent1 Silicon gel

1 2 3

Instructions

4

Open alcohol swab

Clean finger Prick finger with lancet

Use the pipette to collect 1 – 2 drops of 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

rapid-test-kits.com [email protected]

Limitation & Performance Data Characteristics

Blood Borne Test (HIV/HBV/HCV & Syphilis) Sensitivity and SpecificityAppendix 1

Combo for Malaria Sensitivity and SpecificityAppendix 2

Tuberculosis Clinical Sensitivity, Specificity and AccuracyAppendix 3

Dengue IgG/IgM/NS1 Combo Sensitivity and SpecificityAppendix 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 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%.


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



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

HIV 1/2 p24 Ag Rapid Test



Relative sensitivity: >99.99% (97.5%CI*: 97.20%~100.0%);


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



Relative sensitivity: >99.9% (95%CI*: 97.7%~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


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


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

2. Combo for Malaria


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** 0 132 Negative 1 0 432 433

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.


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 of malaria infection.

3. Tuberculosis


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



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 of 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.


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 or 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



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 0 0 IgG 3 0 0

Negative 0 0 0 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


Negative 0 0 0 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


Negative 0 0 338 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)


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.


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


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)



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.


HBsAg Rapid Test Results Positive Negative Positive 205 3 208 Negative 0 310 310


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%.


HCV Rapid Test



Relative sensitivity: 99.1% (95%CI*: 94.9%~100.0%);


Accuracy: 99.4% (95%CI*: 98.6%~99.8%).

*Confidence Interval



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

HIV 1/2 p24 Ag Rapid Test



Relative sensitivity: >99.99% (97.5%CI*: 97.20%~100.0%);


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



Relative sensitivity: >99.9% (95%CI*: 97.7%~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


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


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


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.


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


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

2. Combo for Malaria


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** 0 132 Negative 1 0 432 433

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.


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 of malaria infection.

3. Tuberculosis


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



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 of 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.


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 or 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



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


Negative 0 0 0 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


Negative 0 0 0 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


Negative 0 0 338 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)


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.


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


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.

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Home | Rapid Test Kits · Title: PowerPoint Presentation Author: Keith Created Date: 5/24/2019 10:29:12 AM