2、即使母亲为TOXO急性感染，然而小孩不一定有感染。（要有脐血/羊水的IGM或DNA检测阳性为证，此法一般要到孕18至22进行)；
3、我建议用可靠的TOXO-IGG检测试剂，每两周做一次检测，持续2-3次，若
IGG一直为阴性，考虑第一次TOXO-IGM为假阳性，若IGG为阴性转为阳性，则是TOXO感染的实证！此时，才考虑进一步的医疗措施。
transhold wrote:
这是一家TORCH八个品种：tox igg,igm;cmv igg,igm; hsv1+2 igg,igm;RV igg,igm均通过FDA和CE认证的公司：美国ZEUS公司的产品，详细资料可以EMAIL：transhold@citiz.net进行索取！或登陆www.zeusscientific.com该公司主页中也有详细的说明书和NCCLS格式的文件可以下载！
产品也用的是间接法，八个品种操作相同，据说igm检测也用了去除igg和RF的手段。我摘录了一段TOXO igm 的临床考核数据，不知各位大虾们如何评价该产品？另该公司有标准血清出售，是与WHO标准进行直接溯源的。
请给予赐教！
我在中的package insert 之intended use 中看到了以下一段话：
The Zeus Scientific, Inc. Toxo IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the presumptive qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, and for the presumptive diagnosis of acute, recent, or reactive Toxoplasma gondii infection. This test is for in vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. This assays performance has not been established for screening of prenatal women or newborns.
大家注意看最后一句话: This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. This assays performance has not been established for screening of prenatal women or newborns.
表明:1、我们这个试剂未经FDA批准用做筛查献血员; 2、我们这个试剂用于筛查孕妇和新生儿的有关检测性能还没有建立。试想一下我们做TORCH检测的主要目的就是用于筛查孕妇和新生儿的，如果这个不能做，我们还要它做什么。不过，老外也还好说清楚了什么能做，什么你做了我不负责任。
其实，我是第二次碰到这个问题了，以前我们用trinity的试剂就是这样的。后经分销商与美国联系，对方口头说可以做，但是说明书一直未改过来，也就不了了之。我想里面肯定有文章,可能这一块是一个焦点内容,FDA没有放开,生产商也只能这样做。
elm80tree wrote:
1、母亲TOXO-IGM（+），不一定代表母亲有TOXO急性感染，有研究表明TOXO-IGM最长可在体内存在18个月；
2、即使母亲为TOXO急性感染，然而小孩不一定有感染。（要有脐血/羊水的IGM或DNA检测阳性为证，此法一般要到孕18至22进行)；
3、我建议用可靠的TOXO-IGG检测试剂，每两周做一次检测，持续2-3次，若
IGG一直为阴性，考虑第一次TOXO-IGM为假阳性，若IGG为阴性转为阳性，则是TOXO感染的实证！此时，才考虑进一步的医疗措施。
向您表示感谢！建议非常好。
我没有对国外在TORCH的应用情况做过祥细的了解，但有一点是可以肯定的，那就是如果FDA没有批准，那就说明该方法学还存在这样或那样的问题，美国佬虽然狂妄，但决不马虎，做起学问更是一丝不苟。我绝对没有一丝的不爱国或崇洋媚外，在这一点上，我对国人有不良的应象，特别是一些商家，利用政府管理上的漏洞，把一些没有充分经过临床验证的东西拿到临床上用，由于最近几年国家对药品管理较严，而对检验试剂管理相对松的多，所以这一块成了他们的重点，我们看看最近几年临床新开展的检验项目吧，有很多并没有明确的临床应用指针，在国外仅处于临床应用的研究阶段，对病人是不能收费的（至于是否付费给病人我就不清楚了），可是中国很快就用到临床上来了。这中间有商家的因素，也有医院的原因，由于新项目收费高，可以增加收入，医院在这方面也有意无意的在助长这种风气。而开展的新项目和新技术在很多医院是考核的指标，升职称时也要有新技术的应用考核，每年都要有新项目，人人都要有新项目，但大家有没有想一想，新项目新技术的应用就这么简单，新技术的发展能跟的上这样大的需求吗？因此我认为包括TORCH在内的很多检验项目和检查项目的应用，都应该象PCR一样来个全国大清理，严格明确应用范围和申请指针，而不是现在这样病人看病先来个全套体检，化验费检查费就得好几百甚至上千，而能用得上的指标也就一两个面已。这仅是我的一点个人观点，不对之处还望大家批评
TORCH感染可能导致胎儿畸形，这只是一个可能性，而且概率很低，抗体检验阳性只能说明可能有TORCH感染，这两个可能加在一起，大家认为胎儿畸形的可能性还有多大呢，我有好几个同事检测TORCH抗体中有IGM（+），生下的孩子都很健康。现在在TORCH的就用上存在一个误区，那就是怀孕后再检测，现在都只能生一个孩子，如果抗体阳性，不是在增加孕妇的心理负担吗，孩子留下吧，不放心，不留吧，增加了孕妇的痛苦，弃留两难，而现在因为第一胎人流导致的不育也屡见不鲜。我个人认为，TORCH检测应该在怀孕前做，如果有IGM（+）的，可以用干扰素治疗后再检测，没有IGM（+）结果后再怀孕，怀孕后就没必要再检测了，检测仅仅增加孕妇的心理负担，反而不利于胎儿的发育。
这么可爱的宝宝，怎么舍得........
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TORCH感染可能导致胎儿畸形，这只是一个可能性，而且概率很低，抗体检验阳性只能说明可能有TORCH感染，这两个可能加在一起，大家认为胎儿畸形的可能性还有多大呢，我有好几个同事检测TORCH抗体中有IGM（+），生下的孩子都很健康。现在在TORCH的就用上存在一个误区，那就是怀孕后再检测，现在都只能生一个孩子，如果抗体阳性，不是在增加孕妇的心理负担吗，孩子留下吧，不放心，不留吧，增加了孕妇的痛苦，弃留两难，而现在因为第一胎人流导致的不育也屡见不鲜。我个人认为，TORCH检测应该在怀孕前做，如果有IGM（+）的，可以用干扰素治疗后再检测，没有IGM（+）结果后再怀孕，怀孕后就没必要再检测了，检测仅仅增加孕妇的心理负担，反而不利于胎儿的发育。
这么可爱的宝宝，怎么舍得........
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我也做了两年多，结果确实令人不踏实，每次出结果都是件痛苦的事，且试剂贵，检查费用高，一次检查也说明不了问题，连续检测不太现实。也参加过国家卫生部的QC，结果不太理想。
limedical1974 wrote:
我没有对国外在TORCH的应用情况做过祥细的了解，但有一点是可以肯定的，那就是如果FDA没有批准，那就说明该方法学还存在这样或那样的问题，美国佬虽然狂妄，但决不马虎，做起学问更是一丝不苟。我绝对没有一丝的不爱国或崇洋媚外，在这一点上，我对国人有不良的应象，特别是一些商家，利用政府管理上的漏洞，把一些没有充分经过临床验证的东西拿到临床上用，由于最近几年国家对药品管理较严，而对检验试剂管理相对松的多，所以这一块成了他们的重点，我们看看最近几年临床新开展的检验项目吧，有很多并没有明确的临床应用指针，在国外仅处于临床应用的研究阶段，对病人是不能收费的（至于是否付费给病人我就不清楚了），可是中国很快就用到临床上来了。这中间有商家的因素，也有医院的原因，由于新项目收费高，可以增加收入，医院在这方面也有意无意的在助长这种风气。而开展的新项目和新技术在很多医院是考核的指标，升职称时也要有新技术的应用考核，每年都要有新项目，人人都要有新项目，但大家有没有想一想，新项目新技术的应用就这么简单，新技术的发展能跟的上这样大的需求吗？因此我认为包括TORCH在内的很多检验项目和检查项目的应用，都应该象PCR一样来个全国大清理，严格明确应用范围和申请指针，而不是现在这样病人看病先来个全套体检，化验费检查费就得好几百甚至上千，而能用得上的指标也就一两个面已。这仅是我的一点个人观点，不对之处还望大家批评
您说得太对了。
我不是妇产科的，但是这次陪亲戚复查这个弓形体深有体会：所有检查患者只能做全套 Torch ，而不能选择性复查其中的一种或两种。而且检查结果不一，给孕妇造成很大精神和经济负担。
一声叹息！
以下是USA CDC关于TOXOPLASMA GONDII感染中,抗体检测的一些建议：
The detection of Toxoplasma-specific antibodies is the primary diagnostic method to determine infection with Toxoplasma. Toxoplasma antibody detection tests are performed by a large number of laboratories with commercially available kits.
An algorithm for the immunodiagnosis of toxoplasmosis for individuals greater than one year of age is shown in the following figure. The IFA and EIA tests for IgG and IgM antibodies are the tests most commonly used today. Persons should be initially tested for the presence of Toxoplasma-specific IgG antibodies to determine their immune status. A positive IgG titer indicates infection with the organism at some time. If more precise knowledge of the time of infection is necessary, then an IgG positive person should have an IgM test performed by a procedure with minimal nonspecific reactions, such as IgM-capture EIA. A negative IgM test essentially excludes recent infection, but a positive IgM test is difficult to interpret because Toxoplasma-specific IgM antibodies may be detected by EIA for as long as 18 months after acute acquired infection.
A major problem with Toxoplasma-specific IgM testing is lack of specificity. Two situations occur frequently: i) persons with a positive IgM but negative IgG, and ii) individuals with positive IgG and IgM results. In the first situation, a positive IgM result with a negative IgG result in the same specimen should be viewed with great suspicion; the patient's blood should be redrawn two weeks after the first and tested together with the first specimen. If the first specimen was drawn very early after infection, the patient should have highly positive IgG and IgM antibodies in the second sample. If the IgG is negative and the IgM is positive in both specimens, the IgM result should be considered to be a false positive and the patient should be considered to be not infected. In the second situation, a second specimen should be drawn and both specimens submitted together to a reference lab which employs a different IgM testing system for confirmation. Prior to initiation of patient management for acute toxoplasmosis, all IgM positives should be verified by a reference lab with experience in toxoplasmosis such as CDC or the Toxoplasmosis Serology Lab, Palo Alto Medical Foundation, Palo Alto, CA.
Newborn infants suspected of congenital toxoplasmosis should be tested by both an IgM- and an IgA-capture EIA. Detection of Toxoplasma-specific IgA antibodies is more sensitive than IgM detection in congenitally infected babies. None of the current commercial assays offered in the United States have been cleared by the Food and Drug Administration for in vitro diagnostic use for infants; consequently, all specimens from neonates suspected of having congenital toxoplasmosis should be sent to the Toxoplasma Serology Laboratory, Palo Alto, CA which has the most experience with infant testing.
Serological determination of active central nervous system toxoplasmosis in immunocompromised patients is not possible at this time. Toxoplasma-specific IgG antibody levels in AIDS patients often are low to moderate, but occasionally no specific IgG antibodies can be detected. Tests for IgM antibodies are generally negative.
Several commercial kits for Toxoplasma serologic testing are available. However, the sensitivity and specificity of these kits may vary widely from one commercial brand to another. This is of concern because serology results can influence decisions on continuation or termination of pregnancies
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以下是FDA CDRH中关于Toxoplasma IgM 诊断试剂LIMITATION的一些建议：
The Food and Drug Administration (FDA) is advising physicians that they should not use the result from any one Toxoplasma IgM commercial test kit as the sole determinant of recent Toxoplasma infection when screening a pregnant patient. Because these tests can have false-positive results, reliance on a single test result could lead to misdiagnosis, resulting in unnecessary treatment of the patient and/or termination of the pregnancy.
Background Information ：
Anti-Toxoplasma IgM commercial test kits are used to screen pregnant women to determine recent maternal Toxoplasma infection that might place the fetus at risk for toxoplasmosis. The kits contain reagents used to detect antibodies to Toxoplasma gondii in serum, and were cleared by FDA as an aid in the diagnosis of recently acquired infections which are often without signs or symptoms.
FDA has recently become aware of inaccurate test results from clinical reference laboratories, proficiency testing surveys, the Centers for Disease Control and Prevention (CDC), and the scientific literature. As a result, FDA's Microbiology Devices Advisory Panel recommended that the Agency conduct a pilot study to assess the potential inaccuracy of these commercial test kits and alert the medical community if necessary. Results from the pilot study conducted by FDA and CDC clearly indicated that test kit specificity varies greatly and further study is warranted. At present, the feasibility of additional research is being considered and the FDA is working with the manufacturers of the test kits to provide appropriate labeling information.
Recommendations ：
Physicians are advised to interpret the results of anti-Toxoplasma IgM tests with caution. They should not rely on any single test result as the sole determinant in diagnosing recently acquired infection and deciding on further medical action. If acute infection is suspected, a patient sample should be tested for the presence of Toxoplasma-specific IgG and IgM antibodies. The results should be interpreted using the suggested algorithm for interpretation provided in the accompanying table. The decision to treat or to undertake other medical interventions, including the termination of pregnancy, should be based on clinical evaluation and additional testing performed in reference or research laboratories with experience in the diagnosis of toxoplasmosis.
General Guidelines for Interpretation of Toxoplasma gondii Serology Results：
（1）Igg Result（Negative），Igm result（Negative），Report/interpretation for all except infants ：No serologic evidence of infection with Toxoplasma gondii.
（2）Igg Result（Negative），Igm result（Equivocal），Report/interpretation for all except infants ：Possible early acute infection or false-positive IgM reaction. Obtain a new specimen for IgG and IgM testing. If the new specimen result remains the same, the patient is probably not infected with Toxoplasma gondii.
（3）Igg Result（Negative），Igm result（Positive），Report/interpretation for all except infants ：Possible acute infection or false-positive IgM result. Obtain a new specimen for IgG and IgM testing. If results from the second specimen remain the same, the IgM reaction is probably a false-positive.
（4）Igg Result（Equivocal），Igm result（Negative），Report/interpretation for all except infants ：Indeterminate: obtain a new specimen for testing or retest this specimen for IgG in a different assay.
（5）Igg Result（Equivocal），Igm result（Equivocal），Report/interpretation for all except infants ：Indeterminate: obtain a new specimen for both IgG and IgM testing.
（6）Igg Result（Equivocal），Igm result（Positive），Report/interpretation for all except infants ：Possible acute infection with Toxoplasma gondii. Obtain a new specimen for IgG and IgM testing. If results with the new specimen remain the same or the IgG becomes positive, both specimens should be sent to a reference laboratory with experience in the diagnosis of toxoplasmosis.
（7）Igg Result（Positive），Igm result（Positive），Report/interpretation for all except infants ：Infected with Toxoplasma gondii for more than one year.
（8）Igg Result（Positive），Igm result（Equivocal），Report/interpretation for all except infants ：Infected with Toxoplasma gondii for probably more than one year or false-positive IgM reaction. If results from the second specimen remain the same, both specimens should be sent to a reference laboratory with experience in toxoplasmosis.
（9）Igg Result（Positive），Igm result（Positive），Report/interpretation for all except infants ：Possible recent infection within the last 12 months. Send the specimen to a reference laboratory with experience in the diagnosis of toxoplasmosis.
NOTE: Spiramycin, which is not FDA approved, is manufactured by Rhone-Poulenc Pharmaceuticals and available via individual investigator IND for treatment of pregnant women with toxoplasmosis. As part of this program the company strongly encourages requesting physicians to submit samples for toxoplasmosis testing to Dr. Jack Remington's laboratory in Palo Alto, California. Information on the Spiramycin program is available by calling the Division of Special Pathogens and Immunologic Drug products at FDA at (301) 827-2335.
NOTE: This table was originally developed at FDA/CDRH and refined in cooperation with Jack Remington, MD of the Palo Alto Medical Foundation and the CDC.
出售的标准血清多少钱，谁代理。
您好！我想请教一个问题：在哪里可以找到做TORCH的仪器？我知道有的大型发光仪器可以做，但是我听人说有小一点的仪器也可以。只是不知道在哪里能找到？另外，对TORCH方法学方面，我想请教一下：除了酶免手工、自动ELISA以外，还有其他方法吗？以前好像欧蒙有玻片法？谢谢！！！
elm80tree wrote:
本人从事临床TORCH血清学检验二年多，对国内检验科或妇产科的TORCH血清学检测现状有一些了解，也参加过一些卫临检中心的QA以及美国CAP的anti-toxoplasma igg质评。自已也碰到了不少问题，曾在弓形虫病感染的血清学诊断上载过跟头，因此，对弓形虫病感染的血清学诊断有一些了解，ANTI-TOXPLASMA，IGM/IGG，ELISA/金标法 KIT，国内外试剂皆不稳定，既使是FDA认可的试剂，结果也不敢保证。为了客观评价ANTI-TOXOPLASMA GONDII SEROLOGICAL RERULTS ，FDA特别在1999年提出了一个：FDA Public Health Advisory: Limitations of Toxoplasma IgM Commercial Test Kits,同时美国NCCLS了制定了：clinical use and interpretation of serological toxoplasma gondii ;proposed guideline(M36-P)。目前，国内较好的商业化的ANTI-TOXOPLASMA IGG，为珠海海泰药业的，已有国家批号，而国产的ANTI-TOXOPLASMA IGM，可能尚无质量过得去的商业化的ELISA KIT，更别说金标了。最经典参考方法的ANTI-TOXOPLASMA 检测方法是SABIN-FELDMAN DYE TEST。在美国有专门从事TOXOPLASMOSIS DIAGNOSIS REFERENCE LAB：。在美国所有其他实验室检测的TOXOPLASMA SEROLOGICAL POSITIVE RESULTS SHOULD BE SENT TO THEM TO VERIFY。
希望正在从事此类临床检验工作的同行们，互相交流，解决问题，不能解决问题也要增加认识！但愿未来的日子，我们发出的检验报告能够少一些投诉，多一些自信！
指出一个小错误：珠海海泰药业有注册证的是弓形虫(Toxo)IgM！
请问在各大医院做Torch如何收费?
good
furong_sun wrote:
请问在各大医院做Torch如何收费?
某军医大学附属医院妇产科280元，检验科160元。某医科大学附属医院妇产科180元。都是全套，价格不同，不知道为什么。
anti-toxoplasma 的标准化的重大进展,第四代标准物质的出现.
ion for Human Anti-Toxoplasma Immunoglobulin G.pdf (79.43k)
最近一个朋友做了Torch试验.我感觉结果没有问题,但由于不是专业人士,特来向各位大虾请教.
结果如下:
toxo-igg(弓形体igg抗体测定)和toxo-igm的结果都是阴性
cv-igg(风疹病毒igg抗体测定)是(+)1:80而cv-igm是阴性
cmv-igg(巨细胞病毒igg抗体测定)是(+)1:16而cmv-igm是阴性
hsv-igg(单纯疱疹病毒igg抗体测定)是(+)1:16而hsv-igm是阴性.
各参考值是:
toxo-igg(弓形体igg抗体测定)是<1:1024;cv-igg(风疹病毒igg抗体测定);cmv-igg(巨细胞病毒igg抗体测定);hsv-igg(单纯疱疹病毒igg抗体测定)都是双份血<4倍升高
检查者是女性,32岁.准备怀孕!这个结果应该可以吧?还有什么好的建议?谢谢!
楼上的，兄弟水平有限，看不懂英语，兄弟最好能翻译一下！
单从所报的结果可见：
患者没有出现高滴度的Torch-IgG抗体，且IgM型抗体均为阴性
医生应首先排除患者有感染的其它异常症状如发热淋巴细胞数异常等，需再次实验确认！
此化验单说明排除患者处于感染的急性期！
