Diagnostic Kits | ImmuneMed

Diagnostic Kits

COVID-19 Ag 래피드

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit
(ImmunoChromatography)
Specimen & Test Volume Nasopharyngeal swab
4 drops(190 ㎕)
Reading Time 15 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

Coronavirus Disease-2019 (COVID-19)

COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Common symptoms include fever, cough, fatigue, shortness of breath(dyspnea), sore throat, nausea, diarrhea, and loss of smell and taste. While the majority of cases result in mild symptoms, some progress to acute respiratory distress syndrome (ARDS) likely precipitated by a cytokine storm, multi-organ failure, septic shock, and blood clots. The time from exposure to onset of symptoms is typically around five days but may range from two to fourteen days. The virus is primarily spread between people during close contact, most often via small droplets produced by coughing, sneezing, and talking. Less commonly, people may become infected by touching a contaminated surface and then touching their face. It is most contagious during the first three days after the onset of symptoms, although spread is possible before symptoms appear, and from people who do not show symptoms.

Features

  • Very easy to diagnose COVID-19 from acute stage of initial infection to convalescent stage.
  • As a point-of-care testing(POCT), it is optimized for on-site diagnosis.
  • Store at room temperature (1~30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • Take out a cassette from a pouch for usage

    1Gently insert the sterile swab into the nostril of the patient and then rotate it 3-4 times on the surface of the posterior nasopharynx.

  • Drop 5㎕ of serum or plasma, or 10㎕ of whole blood into sample position

    2Insert the swab into an extraction tube and stir more then 5 times.

  • Drop 4 drops(180㎕) of diluted buffer after dropping specimen

    3Close the filter cap onto extraction tube.

  • Drop 4 drops(180㎕) of diluted buffer after dropping specimen

    4Apply 4 drops(approximately 190㎕) of the extracted specimen into sample well of the test device.

  • Read the result in 15 minutes after specimen application.

    5Read the result in 15 minutes after applying specimen.

  • Interpret the result.

    6Interpret the result.

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Negative

    Negative Result Interpretation
  • Invalid

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE SHELF-LIFE STORAGE TEMP. PACKAGING UNIT
IMMUNEMED COVID-19 Ag RAPID AIC1030 Nasopharyngeal swab 24 months 1~30℃ 30T/Box
Rapid
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • It has a high sensitivity(96.9%, 126/130) and specificity(97.3%, 146/150), and offers an accurate early diagnosis of SARS-CoV-2 infection.
Simple
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a point-of-care testing(POCT), it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
COVID-19 IgM/IgG 래피드

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit
(ImmunoChromatography)
Specimen & Test Volume Serum or Plasma
3 ㎕
Sample Diluent Buffer Volume 4 drops (180㎕)
Reading Time 15 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

Coronavirus Disease-2019 (COVID-19)

COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Common symptoms include fever, cough, fatigue, shortness of breath(dyspnea), sore throat, nausea, diarrhea, and loss of smell and taste. While the majority of cases result in mild symptoms, some progress to acute respiratory distress syndrome (ARDS) likely precipitated by a cytokine storm, multi-organ failure, septic shock, and blood clots. The time from exposure to onset of symptoms is typically around five days but may range from two to fourteen days. The virus is primarily spread between people during close contact, most often via small droplets produced by coughing, sneezing, and talking. Less commonly, people may become infected by touching a contaminated surface and then touching their face. It is most contagious during the first three days after the onset of symptoms, although spread is possible before symptoms appear, and from people who do not show symptoms.

Features

  • Qualitative Test to detect IgM and IgG specific antibodies to SARS-CoV-2 in human serum or plasma.
  • Very easy to diagnose COVID-19 from acute stage of initial infection to convalescent stage.
  • As a point-of-care testing(POCT), it is optimized for on-site diagnosis.
  • Store at room temperature (1~30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • Take out a cassette from a pouch for usage

    1Take out a cassette from a pouch for usage

  • Drop 5㎕ of serum or plasma, or 10㎕ of whole blood into sample position

    2Apply 3㎕ of serum or plasma onto the sample well

  • Drop 4 drops(180㎕) of diluted buffer after dropping specimen

    34 drops(180㎕) of diluent buffer solution are applied onto the sample well

  • Read the result in 15 minutes after specimen application.

    4Read the result in 15 minutes after applying specimen

  • Interpret the result.

    5Interpret the result

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Negative

    Negative Result Interpretation
  • Invalid

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE SHELF-LIFE STORAGE TEMP. PACKAGING UNIT
IMMUNEMED COVID-19 IgM/IgG RAPID AICa1030 Serum or Plasma 24 months 1~30℃ 30T
Rapid
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • It has a Sensitivity(97.7%, 127/130) and Specificity(97.3%, 146/150), and offers an accurate early diagnosis of SARS-CoV-2 infection.
Simple
  • Various samples(serum or plasma) can be used.
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a point-of-care testing(POCT), it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
뎅기 NS1 Ag 래피드

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit (Immunochromatography)
Specimen & Test Volume Serum or Plasma Whole Blood
80 ㎕ 120 ㎕
Diluent Buffer Volume 2 drops (80 ㎕)
Reading Time 20 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

Dengue Fever

Dengue viruses are spread by several species of mosquito and can cause Dengue Fever which is a kind of acute tropical disease in case that human beings are infected. Symptoms may include a high fever, headache, muscle pain, skin rash, joint pain, leukopenia, thrombocytopenia and hemorrhage and in severe cases, patients can die from shock and bleeding.

Features

  • Qualitative Test to detect Dengue NS1 Antigens existing in human bloods(Serum, Plasma & Whole Blood).
  • Store at room temperature (1–30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • A diagnostic kit is prepared for use after it is taken from the pouch

    1A diagnostic kit is prepared for use after it is taken from the pouch.

  • 80 ㎕ of Serum or Plasma, or 120 ㎕ of Whole Blood is injected into the inlet.

    280 ㎕ of Serum or Plasma, or 120 ㎕ of Whole Blood is injected into the inlet.

  • 2 drops(80 ㎕) of diluted buffer solution are injected into the inlet.

    32 drops(80 ㎕) of diluted buffer solution are injected into the inlet.

  • The result is confirmed 20 min later.

    4The result is confirmed 20 min later.

  • The result is then analyzed..

    5The result is then analyzed.

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Negative

    Negative Result Interpretation
  • Nullified

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE PERIOD OF USE STORAGE TEMP PACKAGING UNIT
ImmuneMed Dengue NS1 Ag Rapid AID1030 Whole Blood, Serum, and Plasma 24 months 1~30℃ 30T
Rapid
  • By determining the infection status rapidly (20 min), treatment and prescription can be given on the same day of the test.
Accurate
  • It has a high sensitivity and specificity, and offers an accurate early diagnosis of dengue virus infection.
Simple
  • Various samples (whole blood, serum, plasma) can be used.
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a diagnostic kit, it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
뎅기 IgM/IgG  래피드

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit (Immunochromatography)
Specimen & Test Volume Serum or Plasma Whole Blood
5 ㎕ 10 ㎕
Diluent Buffer Volume 4 drops (180㎕)
Reading Time 15 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

Dengue Fever

Dengue viruses are spread by several species of mosquito and can cause Dengue Fever which is a kind of acute tropical disease in case that human beings are infected. Symptoms may include a high fever, headache, muscle pain, skin rash, joint pain, leukopenia, thrombocytopenia and hemorrhage and in severe cases, patients can die from shock and bleeding.

Features

  • Qualitative Test to detect antibody IgM and IgG specific to Dengue viruses existing in human bloods (Serum, Plasma & Whole Blood).
  • Store at room temperature (1–30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • Take out a cassette from a pouch for usage

    1Take out a cassette from a pouch for usage

  • Drop 5㎕ of serum or plasma, or 10㎕ of whole blood into sample position

    2Drop 5㎕ of serum or plasma, or 10㎕ of whole blood into sample position

  • Drop 4 drops(180㎕) of diluted buffer after dropping specimen

    3Drop 4 drops(180㎕) of diluted buffer after dropping specimen

  • Read the result in 15 minutes after specimen application.

    4Read the result in 15 minutes after specimen application

  • Interpret the result.

    5Interpret the result

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Negative

    Negative Result Interpretation
  • Nullified

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE PERIOD OF USE STORAGE TEMP PACKAGING UNIT
ImmuneMed Dengue IgM/IgG Rapid AIDb1030 Whole Blood, Serum, and Plasma 24 months 1~30℃ 30T
Rapid
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • It has a high sensitivity and specificity, and offers an accurate early diagnosis of dengue virus infection.
Simple
  • Various samples (whole blood, serum, plasma) can be used.
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a diagnostic kit, it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
COVID-19 Ag 래피드

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit
(ImmunoChromatography)
Specimen & Test Volume Nasopharyngeal swab
4 drops(190 ㎕)
Reading Time 15 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

Coronavirus Disease-2019 (COVID-19)

COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Common symptoms include fever, cough, fatigue, shortness of breath(dyspnea), sore throat, nausea, diarrhea, and loss of smell and taste. While the majority of cases result in mild symptoms, some progress to acute respiratory distress syndrome (ARDS) likely precipitated by a cytokine storm, multi-organ failure, septic shock, and blood clots. The time from exposure to onset of symptoms is typically around five days but may range from two to fourteen days. The virus is primarily spread between people during close contact, most often via small droplets produced by coughing, sneezing, and talking. Less commonly, people may become infected by touching a contaminated surface and then touching their face. It is most contagious during the first three days after the onset of symptoms, although spread is possible before symptoms appear, and from people who do not show symptoms.

Features

  • Very easy to diagnose COVID-19 from acute stage of initial infection to convalescent stage.
  • As a point-of-care testing(POCT), it is optimized for on-site diagnosis.
  • Store at room temperature (1~30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • Take out a cassette from a pouch for usage

    1Gently insert the sterile swab into the nostril of the patient and then rotate it 3-4 times on the surface of the posterior nasopharynx.

  • Drop 5㎕ of serum or plasma, or 10㎕ of whole blood into sample position

    2Insert the swab into an extraction tube and stir more then 5 times.

  • Drop 4 drops(180㎕) of diluted buffer after dropping specimen

    3Close the filter cap onto extraction tube.

  • Drop 4 drops(180㎕) of diluted buffer after dropping specimen

    4Apply 4 drops(approximately 190㎕) of the extracted specimen into sample well of the test device.

  • Read the result in 15 minutes after specimen application.

    5Read the result in 15 minutes after applying specimen.

  • Interpret the result.

    6Interpret the result.

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Negative

    Negative Result Interpretation
  • Invalid

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE SHELF-LIFE STORAGE TEMP. PACKAGING UNIT
IMMUNEMED COVID-19 Ag RAPID AIC1030 Nasopharyngeal swab 24 months 1~30℃ 30T/Box
Rapid
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • It has a high sensitivity(96.9%, 126/130) and specificity(97.3%, 146/150), and offers an accurate early diagnosis of SARS-CoV-2 infection.
Simple
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a point-of-care testing(POCT), it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
렙토스피라  래피드

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit (Immunochromatography)
Specimen & Test Volume Serum or Plasma Whole Blood
3 ㎕ 6 ㎕
Diluent Buffer Volume 7 drops (300㎕)
Reading Time 15 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

Leptospirosis

Leptospirosis is a zoonotic disease caused by an infection of Leptospira, and a systemic disease with high fever as its main symptom which is clinically similar with cold. The infection is also caused by directly contacting water, soil, grass, etc. that are contaminated by the urine of infected animals, especially rodents. The other infection symptoms are chills, fever, headache, red eye and muscle ache. In case of severe infection, liver failure, kidney failure and systemic bleeding can occur.

Features

  • Qualitative Test to detect antibody IgM and IgG specific to Leptospira existing in human bloods(Serum, Plasma & Whole Blood).
  • Very easy to diagnose the disease progress and reinfection status since IgM and IgG are analyzed at the same time.
  • Store at room temperature (1–30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • A diagnostic kit is prepared for use after it is taken from the pouch

    1A diagnostic kit is prepared for use after it is taken from the pouch.

  • 3 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

    23 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

  • 7 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

    37 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

  • The result is confirmed 15 min later.

    4The result is confirmed 15 min later.

  • The result is then analyzed..

    5The result is then analyzed.

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Negative

    Negative Result Interpretation
  • Nullified

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE PERIOD OF USE STORAGE TEMP PACKAGING UNIT
ImmuneMed Leptospira Rapid AIL2030 Whole Blood, Serum, and Plasma 24 months 1~30℃ 30T
Rapid
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • It has a high sensitivity (96.4%, 133/138) and specificity (98.4%, 121/123)1), and offers an accurate diagnosis of leptospirosis.
    1)Product permission and function information of the Ministry of Food and Drug Safety
Simple
  • Various samples (whole blood, serum, plasma) can be used.
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a diagnostic kit, it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
렙토스피라 lgM Duo 래피드

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit (Immunochromatography)
Specimen & Test Volume Serum or Plasma Whole Blood
3 ㎕ 6 ㎕
Diluent Buffer Volume 7 drops (300㎕)
Reading Time 15 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

Leptospirosis

Leptospirosis is a zoonotic disease caused by an infection of Leptospira, and a systemic disease with high fever as its main symptom which is clinically similar with cold. The infection is also caused by directly contacting water, soil, grass, etc. that are contaminated by the urine of infected animals, especially rodents. The other infection symptoms are chills, fever, headache, red eye and muscle ache. In case of severe infection, liver failure, kidney failure and systemic bleeding can occur.

Features

  • Semi-quantitative Test to detect antibody IgM and IgG specific to Leptospira existing in human bloods(Serum, Plasma & Whole Blood).
  • Very useful to diagnose the disease in Endemic region.
  • Store at room temperature (1–30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • A diagnostic kit is prepared for use after it is taken from the pouch

    1A diagnostic kit is prepared for use after it is taken from the pouch.

  • 3 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

    23 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

  • 7 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

    37 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

  • The result is confirmed 15 min later.

    4The result is confirmed 15 min later.

  • The result is then analyzed..

    5The result is then analyzed.

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Re-experiment after 2 to 7 days Result Interpretation
  • Negative

    Negative Result Interpretation
  • Nullified

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE PERIOD OF USE STORAGE TEMP PACKAGING UNIT
ImmuneMed Leptospira IgM Duo Rapid AILd2030 Whole Blood, Serum, and Plasma 24 months 1~30℃ 30T
Rapid
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • Through the P window (epidemic region) and the N window (endemic region), in endemic regions, such as Malaysia, where leptospirosis frequently occurs, a diagnosis of the disease is possible with the high specificity.
  • It has a high sensitivity and specificity and offers an accurate diagnosis of leptospirosis.
Simple
  • Various samples (whole blood, serum, plasma) can be used.
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a diagnostic kit, it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
Scrub Typhus Rapid

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit (Immunochromatography)
Specimen & Test Volume Serum or Plasma Whole Blood
3 ㎕ 6 ㎕
Diluent Buffer Volume 7 drops (300㎕)
Reading Time 15 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (4~30℃)
Package 30 T/Box

Scrub Typhus

Scrub Typhus is an acute febrile illness caused by an infection of Orientia tsutsugamushi. Its clinical symptoms include early fever, chills and headache which are those similar to cold, and also muscle ache, cough, vomiting, abdominal pain and sore throat. This disease is transmitted by some species of trombiculid mites(chiggers) and the bite of this mite leaves a characteristic black eschar that is useful to the doctor for making the diagnosis.

The condition of a person infected with the disease improves in one to two days if treated properly. However, if not treated properly, fever lasts for about two weeks. Thus, an early definite diagnosis is very important.

Features

  • Qualitative Test to detect antibody IgM and IgG specific to Orientia tsutsugamushi existing in human bloods(Serum, Plasma & Whole Blood).
  • Very easy to diagnose the disease progress and reinfection status since IgM and IgG are analyzed at the same time.
  • Store at room temperature (1–30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • A diagnostic kit is prepared for use after it is taken from the pouch

    1A diagnostic kit is prepared for use after it is taken from the pouch.

  • 3 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

    23 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

  • 7 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

    37 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

  • The result is confirmed 15 min later.

    4The result is confirmed 15 min later.

  • The result is then analyzed..

    5The result is then analyzed.

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Negative

    Negative Result Interpretation
  • Nullified

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE PERIOD OF USE STORAGE TEMP PACKAGING UNIT
ImmuneMed Scrub Typhus Rapid AIS2030 Whole Blood, Serum, and Plasma 24 months 4~30℃ 30T
Rapid
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • By mixing the chimeric antigen and the adjuvant antigen, various serotypes can be confirmed.
  • It has a high sensitivity (97.3%, 146/150) and specificity (99.5%, 198/199)1) and offers an accurate diagnosis of tsutsugamushi disease.
    1) Product permission and function information of the Ministry of Food and Drug Safety
Simple
  • Various samples (whole blood, serum, plasma) can be used.
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a diagnostic kit, it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
Hanta Rapid

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit (Immunochromatography)
Specimen & Test Volume Serum or Plasma Whole Blood
3 ㎕ 6 ㎕
Diluent Buffer Volume 7 drops (300㎕)
Reading Time 15 minutes
Shelf-life 18 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

Hemorrhagic Fever with Renal Syndrome

Hemorrhagic fever with renal syndrome is an acute febrile illness caused by viruses such as Hantaan, Seoul, Dobrava, Puumala, etc. which belong to Hantavirus family with fever, hemorrhage and kidney failure as its three main symptoms. Viruses are excreted to the environment through saliva, urine, feces, etc. of rodents that are infected with, and as the excretion is dried, Human beings can be infected through their respiratory organs.

Features

  • Qualitative Test to detect antibody IgM and IgG specific to Hantavirus existing in human bloods(Serum, Plasma & Whole Blood).
  • Very easy to diagnose the disease progress and reinfection status since IgM and IgG are analyzed at the same time.
  • Store at room temperature (1–30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • A diagnostic kit is prepared for use after it is taken from the pouch

    1A diagnostic kit is prepared for use after it is taken from the pouch.

  • 3 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

    23 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

  • 7 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

    37 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

  • The result is confirmed 15 min later.

    4The result is confirmed 15 min later.

  • The result is then analyzed..

    5The result is then analyzed.

Result Interpretation

  • Positive

    Positive Result Interpretation
  • Negative

    Negative Result Interpretation
  • Nullified

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE PERIOD OF USE STORAGE TEMP PACKAGING UNIT
ImmuneMed Hanta Rapid AIH2030 Whole Blood, Serum, and Plasma 18 months 1~30℃ 30T
Rapid
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • It has a high sensitivity (100%, 130/130) and specificity (98.2%, 167/170)1), and offers an accurate diagnosis of hemorrhagic fever with renal syndrome.
    1) Product permission and function information of the Ministry of Food and Drug Safety
Simple
  • Various samples (whole blood, serum, plasma) can be used.
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a diagnostic kit, it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP
AFI Rapid

Product Details

제품 상세 정보
Product Type Qualitative Rapid Diagnostic Kit (Immunochromatography)
Specimen & Test Volume Serum or Plasma Whole Blood
3 ㎕ 6 ㎕
Diluent Buffer Volume 7 drops (300㎕)
Reading Time 15 minutes
Shelf-life 24 months
Storage Temp. Room Temperature (1~30℃)
Package 30 T/Box

AFI Rapid

By performing just single test, a rapid screening of diseases of patients who are infected with Leptospirosis, Scrub typhus and/or Hemorrhagic fever with renal syndrome which are acute febrile illnesses can be performed.

Features

  • Qualitative Test to detect antibody IgM and IgG specific to Leptospira, Orientia tsutsugamushi and Hantavirus existing in human bloods(Serum, Plasma & Whole Blood).
  • Very easy to diagnose the disease progress and reinfection status since IgM and IgG are analyzed at the same time.
  • Store at room temperature (1–30°C).
  • Very rapidly interpret the test results.

Test Procedure

  • A diagnostic kit is prepared for use after it is taken from the pouch

    1A diagnostic kit is prepared for use after it is taken from the pouch.

  • 3 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

    23 ㎕ of Serum or Plasma, or 6 ㎕ of Whole Blood is injected into the inlet.

  • 7 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

    37 drops(300 ㎕) of diluted buffer solution are injected into the inlet.

  • The result is confirmed 15 min later.

    4The result is confirmed 15 min later.

  • The result is then analyzed.

    5The result is then analyzed.

Result Interpretation

  • Positive(Leptospirosis)

    Positive(Leptospirosis) Result Interpretation
  • Positive(Tsutsugamushi disease)

    Positive(Tsutsugamushi disease) Result Interpretation
  • Positive(Hemorrhagic fever with renal syndrome)

    Positive(Hemorrhagic fever with renal syndrome) Result Interpretation
  • Negative

    Negative Result Interpretation
  • Nullified

    Nullified Result Interpretation

    Invalid if no C line comes out

Order Information

Order Information
PRODUCT NAME Cat No. SAMPLE TYPE PERIOD OF USE STORAGE TEMP PACKAGING UNIT
ImmuneMed AFI Rapid AIA2030 Whole Blood, Serum, and Plasma 24 months 1~30℃ 30T
Rapid
  • By performing one test, acute febrile illnesses can be screened rapidly.
  • By determining the infection status rapidly (15 min), treatment and prescription can be given on the same day of the test.
Accurate
  • It has a high sensitivity and specificity, and offers an accurate diagnosis of leptospirosis, tsutsugamushi disease, and/or hemorrhagic fever with renal syndrome.
Simple
  • Various samples (whole blood, serum, plasma) can be used.
  • With just three to four steps of the test procedure, a test can be performed easily.
  • As a diagnostic kit, it is optimized for on-site diagnosis.

Certification List

인증목록 정보
No. Certificate NameCertificate List Country Certification Authority
1 ISO13485 인증명 : ISO13485
  • 인증국가
    Germany
  • 인증기관
    TUV
Germany TUV
2 KGMP 인증명 : KGMP
  • 인증국가
    Republic of Korea
  • 인증기관
    Seoul Regional Korea Food Drug Administration
Republic of Korea Seoul Regional Korea Food Drug Administration
ISO13485
KGMP